Section 15 Security: The Digital Fortress that Pharmaceutical IT Never Knew It Needed

The draft Annex 11’s Section 15 Security represents nothing less than the regulatory codification of modern cybersecurity principles into pharmaceutical GMP. Where the 2011 version offered three brief security provisions totaling fewer than 100 words, the 2025 draft delivers 20 comprehensive subsections that read like a cybersecurity playbook designed by paranoid auditors who’ve spent too much time investigating ransomware attacks on manufacturing facilities. As someone with a bit of experience in that, I find the draft fascinating.

Section 15 transforms cybersecurity from a peripheral IT concern into a mandatory foundation of pharmaceutical operations, requiring organizations to implement enterprise-grade security controls. The European regulators have essentially declared that pharmaceutical cybersecurity can no longer be treated as someone else’s problem. Nor can it be treated as something outside of the GMPs.

The Philosophical Transformation: From Trust-Based to Threat-Driven Security

The current Annex 11’s security provisions reflect a fundamentally different era of threat landscape with an approach centering on access restriction and basic audit logging, assuming that physical controls and password authentication provide adequate protection. The language suggests that security controls should be “suitable” and scale with system “criticality,” offering organizations considerable discretion in determining what constitutes appropriate protection.

Section 15 obliterates this discretionary approach by mandating specific, measurable security controls that assume persistent, sophisticated threats as the baseline condition. Rather than suggesting organizations “should” implement firewalls and access controls, the draft requires organizations to deploy network segmentation, disaster recovery capabilities, penetration testing programs, and continuous security improvement processes.

The shift from “suitable methods of preventing unauthorised entry” to requiring “effective information security management systems” represents a fundamental change in regulatory philosophy. The 2011 version treats security breaches as unfortunate accidents to be prevented through reasonable precautions. The 2025 draft treats security breaches as inevitable events requiring comprehensive preparation, detection, response, and recovery capabilities.

Section 15.1 establishes this new paradigm by requiring regulated users to “ensure an effective information security management system is implemented and maintained, which safeguards authorised access to, and detects and prevents unauthorised access to GMP systems and data”. This language transforms cybersecurity from an operational consideration into a regulatory mandate with explicit requirements for ongoing management and continuous improvement.

Quite frankly, I worry that many Quality Units may not be ready for this new level of oversight.

Comparing Section 15 Against ISO 27001: Pharmaceutical-Specific Cybersecurity

The draft Section 15 creates striking alignments with ISO 27001’s Information Security Management System requirements while adding pharmaceutical-specific controls that reflect the unique risks of GMP environments. ISO 27001’s emphasis on risk-based security management, continuous improvement, and comprehensive control frameworks becomes regulatory mandate rather than voluntary best practice.

Physical Security Requirements in Section 15.4 exceed typical ISO 27001 implementations by mandating multi-factor authentication for physical access to server rooms and data centers. Where ISO 27001 Control A.11.1.1 requires “physical security perimeters” and “appropriate entry controls,” Section 15.4 specifically mandates protection against unauthorized access, damage, and loss while requiring secure locking mechanisms for data centers.

The pharmaceutical-specific risk profile drives requirements that extend beyond ISO 27001’s framework. Section 15.5’s disaster recovery provisions require data centers to be “constructed to minimise the risk and impact of natural and manmade disasters” including storms, flooding, earthquakes, fires, power outages, and network failures. This level of infrastructure resilience reflects the critical nature of pharmaceutical manufacturing where system failures can impact patient safety and drug supply chains.

Continuous Security Improvement mandated by Section 15.2 aligns closely with ISO 27001’s Plan-Do-Check-Act cycle while adding pharmaceutical-specific language about staying “updated about new security threats” and implementing measures to “counter this development”. The regulatory requirement transforms ISO 27001’s voluntary continuous improvement into a compliance obligation with potential inspection implications.

The Security Training and Testing requirements in Section 15.3 exceed typical ISO 27001 implementations by mandating “recurrent security awareness training” with effectiveness evaluation through “simulated tests”. This requirement acknowledges that pharmaceutical environments face sophisticated social engineering attacks targeting personnel with access to valuable research data and manufacturing systems.

NIST Cybersecurity Framework Convergence: Functions Become Requirements

Section 15’s structure and requirements create remarkable alignment with NIST Cybersecurity Framework 2.0’s core functions while transforming voluntary guidelines into mandatory pharmaceutical compliance requirements. The NIST CSF’s Identify, Protect, Detect, Respond, and Recover functions become implicit organizing principles for Section 15’s comprehensive security controls.

Asset Management and Risk Assessment requirements embedded throughout Section 15 align with NIST CSF’s Identify function. Section 15.8’s network segmentation requirements necessitate comprehensive asset inventories and network topology documentation, while Section 15.10’s platform management requirements demand systematic tracking of operating systems, applications, and support lifecycles.

The Protect function manifests through Section 15’s comprehensive defensive requirements including network segmentation, firewall management, access controls, and encryption. Section 15.8 mandates that “networks should be segmented, and effective firewalls implemented to provide barriers between networks, and control incoming and outgoing network traffic”. This requirement transforms NIST CSF’s voluntary protective measures into regulatory obligations with specific technical implementations.

Detection capabilities appear in Section 15.19’s penetration testing requirements, which mandate “regular intervals” of ethical hacking assessments for “critical systems facing the internet”. Section 15.18’s anti-virus requirements extend detection capabilities to endpoint protection with requirements for “continuously updated” virus definitions and “effectiveness monitoring”.

The Respond function emerges through Section 15.7’s disaster recovery planning requirements, which mandate tested disaster recovery plans ensuring “continuity of operation within a defined Recovery Time Objective (RTO)”. Section 15.13’s timely patching requirements create response obligations for addressing “critical vulnerabilities” that “might be immediately” requiring patches.

Recovery capabilities center on Section 15.6’s data replication requirements, which mandate automatic replication of “critical data” from primary to secondary data centers with “delay which is short enough to minimise the risk of loss of data”. The requirement for secondary data centers to be located at “safe distance from the primary site” ensures geographic separation supporting business continuity objectives.

Summary Across Key Guidance Documents

Security Requirement Area	Draft Annex 11 Section 15 (2025)	Current Annex 11 (2011)	ISO 27001:2022	NIST CSF 2.0 (2024)	Implementation Complexity
Information Security Management System	Mandatory – Effective ISMS implementation and maintenance required (15.1)	Basic – General security measures, no ISMS requirement	Core – ISMS is fundamental framework requirement (Clause 4-10)	Framework – Governance as foundational function across all activities	High – Requires comprehensive ISMS deployment
Continuous Security Improvement	Required – Continuous updates on threats and countermeasures (15.2)	Not specified – No continuous improvement mandate	Mandatory – Continual improvement through PDCA cycle (Clause 10.2)	Built-in – Continuous improvement through framework implementation	Medium – Ongoing process establishment needed
Security Training & Testing	Mandatory – Recurrent training with simulated testing effectiveness evaluation (15.3)	Not mentioned – No training or testing requirements	Required – Information security awareness and training (A.6.3)	Emphasized – Cybersecurity workforce development and training (GV.WF)	Medium – Training programs and testing infrastructure
Physical Security Controls	Explicit – Multi-factor authentication for server rooms, secure data centers (15.4)	Limited – “Suitable methods” for preventing unauthorized entry	Detailed – Physical and environmental security controls (A.11.1-11.2)	Addressed – Physical access controls within Protect function (PR.AC-2)	Medium – Physical infrastructure and access systems
Network Segmentation & Firewalls	Mandatory – Network segmentation with strict firewall rules, periodic reviews (15.8-15.9)	Basic – Firewalls mentioned without specific requirements	Specified – Network security management and segmentation (A.13.1)	Core – Network segmentation and boundary protection (PR.AC-5, PR.DS-5)	High – Network architecture redesign often required
Platform & Patch Management	Required – Timely OS updates, validation before vendor support expires (15.10-15.14)	Not specified – No explicit platform or patch management	Required – System security and vulnerability management (A.12.6, A.14.2)	Essential – Vulnerability management and patch deployment (ID.RA-1, RS.MI)	High – Complex validation and lifecycle management
Disaster Recovery & Business Continuity	Mandatory – Tested disaster recovery with defined RTO requirements (15.7)	Not mentioned – No disaster recovery requirements	Comprehensive – Information systems availability and business continuity (A.17)	Fundamental – Recovery planning and business continuity (RC.RP, RC.CO)	High – Business continuity infrastructure and testing
Data Replication & Backup	Required – Automatic critical data replication to geographically separated sites (15.6)	Limited – Basic backup provisions only	Required – Information backup and recovery procedures (A.12.3)	Critical – Data backup and recovery capabilities (PR.IP-4, RC.RP-1)	High – Geographic replication and automated systems
Endpoint Security & Device Control	Strict – USB port controls, bidirectional device scanning, default deactivation (15.15-15.17)1	Not specified – No device control requirements	Detailed – Equipment maintenance and secure disposal (A.11.2, A.11.2.7)	Important – Removable media and device controls (PR.PT-2)	Medium – Device management and scanning systems
Anti-virus & Malware Protection	Mandatory – Continuously updated anti-virus with effectiveness monitoring (15.18)	Not mentioned – No anti-virus requirements	Required – Protection against malware (A.12.2)	Standard – Malicious code protection (PR.PT-1)	Low – Standard anti-virus deployment
Penetration Testing	Required – Regular ethical hacking for internet-facing critical systems (15.19)	Not specified – No penetration testing requirements	Recommended – Technical vulnerability testing (A.14.2.8)	Recommended – Vulnerability assessments and penetration testing (DE.CM)	Medium – External testing services and internal capabilities
Risk-Based Security Assessment	Implicit – Risk-based approach integrated throughout all requirements	General – Risk assessment mentioned but not detailed	Fundamental – Risk management is core methodology (Clause 6.1.2)	Core – Risk assessment and management across all functions (GV.RM, ID.RA)	Medium – Risk assessment processes and documentation
Access Control & Authentication	Enhanced – Beyond basic access controls, integrated with physical security	Basic – Password protection and access restriction only	Comprehensive – Access control management framework (A.9)	Comprehensive – Identity management and access controls (PR.AC)	Medium – Enhanced access control systems
Incident Response & Management	Implied – Through disaster recovery and continuous improvement requirements	Not specified – No incident response requirements	Required – Information security incident management (A.16)	Detailed – Incident response and recovery processes (RS, RC functions)	Medium – Incident response processes and teams
Documentation & Audit Trail	Comprehensive – Detailed documentation for all security controls and testing	Limited – Basic audit trail and documentation	Mandatory – Documented information and records management (Clause 7.5)	Integral – Documentation and communication throughout framework	High – Comprehensive documentation and audit systems
Third-Party Risk Management	Implicit – Through platform management and network security requirements	Not mentioned – No third-party risk provisions	Required – Supplier relationships and information security (A.15)	Addressed – Supply chain risk management (ID.SC, GV.SC)	Medium – Supplier assessment and management processes
Encryption & Data Protection	Limited – Not explicitly detailed beyond data replication requirements	Not specified – No encryption requirements	Comprehensive – Cryptography and data protection controls (A.10)	Included – Data security and privacy protection (PR.DS)	Medium – Encryption deployment and key management
Change Management Integration	Integrated – Security updates must align with GMP validation processes	Basic – Change control mentioned generally	Integrated – Change management throughout ISMS (A.14.2.2)	Embedded – Change management within improvement processes	High – Integration with existing GMP change control
Compliance Monitoring	Built-in – Regular reviews, testing, and continuous improvement mandated	Limited – Periodic review mentioned without specifics	Required – Monitoring, measurement, and internal audits (Clause 9)	Systematic – Continuous monitoring and measurement (DE, GV functions)	Medium – Monitoring and measurement systems
Executive Oversight & Governance	Implied – Through ISMS requirements and continuous improvement mandates	Not specified – No governance requirements	Mandatory – Leadership commitment and management responsibility (Clause 5)	Essential – Governance and leadership accountability (GV function)4	Medium – Governance structure and accountability

The alignment with ISO 27001 and NIST CSF demonstrates that pharmaceutical organizations can no longer treat cybersecurity as a separate concern from GMP compliance—they become integrated regulatory requirements demanding enterprise-grade security capabilities that most pharmaceutical companies have historically considered optional.

Technical Requirements That Challenge Traditional Pharmaceutical IT Architecture

Section 15’s technical requirements will force fundamental changes in how pharmaceutical organizations architect, deploy, and manage their IT infrastructure. The regulatory prescriptions extend far beyond current industry practices and demand enterprise-grade security capabilities that many pharmaceutical companies currently lack.

Network Architecture Revolution begins with Section 15.8’s segmentation requirements, which mandate that “networks should be segmented, and effective firewalls implemented to provide barriers between networks”. This requirement eliminates the flat network architectures common in pharmaceutical manufacturing environments where laboratory instruments, manufacturing equipment, and enterprise systems often share network segments for operational convenience.

The firewall rule requirements demand “IP addresses, destinations, protocols, applications, or ports” to be “defined as strict as practically feasible, only allowing necessary and permissible traffic”. For pharmaceutical organizations accustomed to permissive network policies that allow broad connectivity for troubleshooting and maintenance, this represents a fundamental shift toward zero-trust architecture principles.

Section 15.9’s firewall review requirements acknowledge that “firewall rules tend to be changed or become insufficient over time” and mandate periodic reviews to ensure firewalls “continue to be set as tight as possible”. This requirement transforms firewall management from a deployment activity into an ongoing operational discipline requiring dedicated resources and systematic review processes.

Platform and Patch Management requirements in Sections 15.10 through 15.14 create comprehensive lifecycle management obligations that most pharmaceutical organizations currently handle inconsistently. Section 15.10 requires operating systems and platforms to be “updated in a timely manner according to vendor recommendations, to prevent their use in an unsupported state”.

The validation and migration requirements in Section 15.11 create tension between security imperatives and GMP validation requirements. Organizations must “plan and complete” validation of applications on updated platforms “in due time prior to the expiry of the vendor’s support”. This requirement demands coordination between IT security, quality assurance, and validation teams to ensure system updates don’t compromise GMP compliance.

Section 15.12’s isolation requirements for unsupported platforms acknowledge the reality that pharmaceutical organizations often operate legacy systems that cannot be easily updated. The requirement that such systems “should be isolated from computer networks and the internet” creates network architecture challenges where isolated systems must still support critical manufacturing processes.

Endpoint Security and Device Management requirements in Sections 15.15 through 15.18 address the proliferation of connected devices in pharmaceutical environments. Section 15.15’s “strict control” of bidirectional devices like USB drives acknowledges that pharmaceutical manufacturing environments often require portable storage for equipment maintenance and data collection.

The effective scanning requirements in Section 15.16 for devices that “may have been used outside the organisation” create operational challenges for service technicians and contractors who need to connect external devices to pharmaceutical systems. Organizations must implement scanning capabilities that can “effectively” detect malware without disrupting operational workflows.

Section 15.17’s requirements to deactivate USB ports “by default” unless needed for essential devices like keyboards and mice will require systematic review of all computer systems in pharmaceutical facilities. Manufacturing computers, laboratory instruments, and quality control systems that currently rely on USB connectivity for routine operations may require architectural changes or enhanced security controls.

Operational Impact: How Section 15 Changes Day-to-Day Operations

The implementation of Section 15’s security requirements will fundamentally change how pharmaceutical organizations conduct routine operations, from equipment maintenance to data management to personnel access. These changes extend far beyond IT departments to impact every function that interacts with computerized systems.

Manufacturing and Laboratory Operations will experience significant changes through network segmentation and access control requirements. Section 15.8’s segmentation requirements may isolate manufacturing systems from corporate networks, requiring new procedures for accessing data, transferring files, and conducting remote troubleshooting1. Equipment vendors who previously connected remotely to manufacturing systems for maintenance may need to adapt to more restrictive access controls and monitored connections.

The USB control requirements in Sections 15.15-15.17 will particularly impact operations where portable storage devices are routinely used for data collection, equipment calibration, and maintenance activities. Laboratory personnel accustomed to using USB drives for transferring analytical data may need to adopt network-based file transfer systems or enhanced scanning procedures.

Information Technology Operations must expand significantly to support Section 15’s comprehensive requirements. The continuous security improvement mandate in Section 15.2 requires dedicated resources for threat intelligence monitoring, security tool evaluation, and control implementation. Organizations that currently treat cybersecurity as a periodic concern will need to establish ongoing security operations capabilities.

Section 15.19’s penetration testing requirements for “critical systems facing the internet” will require organizations to either develop internal ethical hacking capabilities or establish relationships with external security testing providers. The requirement for “regular intervals” suggests ongoing testing programs rather than one-time assessments.

The firewall review requirements in Section 15.9 necessitate systematic processes for evaluating and updating network security rules. Organizations must establish procedures for documenting firewall changes, reviewing rule effectiveness, and ensuring rules remain “as tight as possible” while supporting legitimate business functions.

Quality Unit functions must expand to encompass cybersecurity validation and documentation requirements. Section 15.11’s requirements to validate applications on updated platforms before vendor support expires will require QA involvement in IT infrastructure changes. Quality systems must incorporate procedures for evaluating the GMP impact of security patches, platform updates, and network changes.

The business continuity requirements in Section 15.7 necessitate testing of disaster recovery plans and validation that systems can meet “defined Recovery Time Objectives”. Quality assurance must develop capabilities for validating disaster recovery processes and documenting that backup systems can support GMP operations during extended outages.

Strategic Implications: Organizational Structure and Budget Priorities

Section 15’s comprehensive security requirements will force pharmaceutical organizations to reconsider their IT governance structures, budget allocations, and strategic priorities. The regulatory mandate for enterprise-grade cybersecurity capabilities creates organizational challenges that extend beyond technical implementation.

IT-OT Convergence Acceleration becomes inevitable as Section 15’s requirements apply equally to traditional IT systems and operational technology supporting manufacturing processes. Organizations must develop unified security approaches spanning enterprise networks, manufacturing systems, and laboratory instruments. The traditional separation between corporate IT and manufacturing systems operations becomes unsustainable when both domains require coordinated security management.

The network segmentation requirements in Section 15.8 demand comprehensive understanding of all connected systems and their communication requirements. Organizations must develop capabilities for mapping and securing complex environments where ERP systems, manufacturing execution systems, laboratory instruments, and quality management applications share network infrastructure.

Cybersecurity Organizational Evolution will likely drive consolidation of security responsibilities under dedicated chief information security officer roles with expanded authority over both IT and operational technology domains. The continuous improvement mandates and comprehensive technical requirements demand specialized cybersecurity expertise that extends beyond traditional IT administration.

Section 15.3’s training and testing requirements necessitate systematic cybersecurity awareness programs with “effectiveness evaluation” through simulated attacks1. Organizations must develop internal capabilities for conducting phishing simulations, security training programs, and measuring personnel security behaviors.

Budget and Resource Reallocation becomes necessary to support Section 15’s comprehensive requirements. The penetration testing, platform management, network segmentation, and disaster recovery requirements represent significant ongoing operational expenses that many pharmaceutical organizations have not historically prioritized.

The validation requirements for security updates in Section 15.11 create ongoing costs for qualifying platform changes and validating application compatibility. Organizations must budget for accelerated validation cycles to ensure security updates don’t result in unsupported systems.

Inspection and Enforcement: The New Reality

Section 15’s detailed technical requirements create specific inspection targets that regulatory authorities can evaluate objectively during facility inspections. Unlike the current Annex 11’s general security provisions, Section 15’s prescriptive requirements enable inspectors to assess compliance through concrete evidence and documentation.

Technical Evidence Requirements emerge from Section 15’s specific mandates for firewalls, network segmentation, patch management, and penetration testing. Inspectors can evaluate firewall configurations, review network topology documentation, assess patch deployment records, and verify penetration testing reports. Organizations must maintain detailed documentation demonstrating compliance with each technical requirement.

The continuous improvement mandate in Section 15.2 creates expectations for ongoing security enhancement activities with documented evidence of threat monitoring and control implementation. Inspectors will expect to see systematic processes for identifying emerging threats and implementing appropriate countermeasures.

Operational Process Validation requirements extend to security operations including incident response, access control management, and backup testing. Section 15.7’s disaster recovery testing requirements create inspection opportunities for validating recovery procedures and verifying RTO achievement1. Organizations must demonstrate that their business continuity plans work effectively through documented testing activities.

The training and testing requirements in Section 15.3 create audit trails for security awareness programs and simulated attack exercises. Inspectors can evaluate training effectiveness through documentation of phishing simulation results, security incident responses, and personnel security behaviors.

Industry Transformation: From Compliance to Competitive Advantage

Organizations that excel at implementing Section 15’s requirements will gain significant competitive advantages through superior operational resilience, reduced cyber risk exposure, and enhanced regulatory relationships. The comprehensive security requirements create opportunities for differentiation through demonstrated cybersecurity maturity.

Supply Chain Security Leadership emerges as pharmaceutical companies with robust cybersecurity capabilities become preferred partners for collaborations, clinical trials, and manufacturing agreements. Section 15’s requirements create third-party evaluation criteria that customers and partners can use to assess supplier cybersecurity capabilities.

The disaster recovery and business continuity requirements in Sections 15.6 and 15.7 create operational resilience that supports supply chain reliability. Organizations that can demonstrate rapid recovery from cyber incidents maintain competitive advantages in markets where supply chain disruptions have significant patient impact.

Regulatory Efficiency Benefits accrue to organizations that proactively implement Section 15’s requirements before they become mandatory. Early implementation demonstrates regulatory leadership and may result in more efficient inspection processes and enhanced regulatory relationships.

The systematic approach to cybersecurity documentation and process validation creates operational efficiencies that extend beyond compliance. Organizations that implement comprehensive cybersecurity management systems often discover improvements in change control, incident response, and operational monitoring capabilities.

Section 15 Security ultimately represents the transformation of pharmaceutical cybersecurity from optional IT initiative to mandatory operational capability that is part of the pharmaceutical quality system. The pharmaceutical industry’s digital future depends on treating cybersecurity as seriously as traditional quality assurance—and Section 15 makes that treatment legally mandatory.

Crowdstrike debacle, Three Brief Thougths

This is not an unexpected accident. It has happened before on a smaller scale. We’ve seen companies like Crowdstrike under-resource their system controls that should prevent this. There is probably a strong case for regulation here. Maybe the EU will do something.
Pharma companies should consider situations like the Crowdstrike incident in their business continuity plans. Plan for a week or more of what happened Friday.
While my flight was only delayed an hour, there were sure to be a lot of grumpy and angry-looking people at Sea-Tac and Logan. I really think if we didn’t have a dysfunctional Congress, we would have seen a real change in how the airline industry is regulated by now.

Back Up and Recovery Testing

Backup and recovery testing are critical to ensuring data integrity and business continuity for critical computerized systems. They are also a hard regulatory requirement in our computer system lifecycle.

Part 11 (21 CFR 11.10 and 11.30) requires that:
“For the availability of computerized systems supporting critical processes, provisions should be made to ensure continuity of the systems in the event of an incident or system failure. This includes implementing adequate backup and recovery measures, as well as providing sufficient system redundancy and failover mechanisms.”

Part 11 also requires that “The backup and recovery processes must be validated in order to ensure that they operate in an effective and reliable manner.”

Similarly, Annex 11 requires that backup and recovery processes be validated to ensure they operate reliably and effectively. Annex 11 also requires that the validation process be documented and includes a risk assessment of the system’s critical processes.

Similar requirements can be found across the GxP data integrity requirements.

The regulatory requirements require that backup and recovery processes be validated to ensure they can reliably recover the system in case of an incident or failure. This validation process must be documented, including a risk assessment of the system’s critical processes.

Backup and recovery testing:

Verifies Backup Integrity: Testing backups lets you verify that the backup data is complete, accurate, and not corrupted. It ensures that the backed-up data can be reliably restored when needed, maintaining the integrity of the original data.
Validates Recovery Procedures: Regularly testing the recovery process helps identify and resolve any issues or gaps in the recovery procedures. This ensures that the data can be restored wholly and correctly, preserving its integrity during recovery.
Identifies Data Corruption: Testing can reveal data corruption that may have gone unnoticed. By restoring backups and comparing them with the original data, you can detect and address any data integrity issues before they become critical.
Improves Disaster Preparedness: Regular backup and recovery testing helps organizations identify and address potential issues before a disaster strikes. This improves the organization’s preparedness and ability to recover data with integrity in a disaster or data loss incident.
Maintains Business Continuity: Backup and recovery testing helps maintain business continuity by ensuring that backups are reliable and recovery procedures are adequate. Organizations can minimize downtime and data loss, ensuring the integrity of critical business data and operations.

To maintain data integrity, it is recommended that backup and recovery testing be performed regularly. This should follow industry best practices and adhere to the organization’s recovery time objectives (RTOs) and recovery point objectives (RPOs). Testing should cover various scenarios, including full system restores, partial data restores, and data validation checks.

Level	Description	Key Activities	Frequency
Backup Tests	Ensures data is backed up correctly and consistently.	– Check backup infrastructure health – Verify data consistency – Ensure all critical data is covered – Check security settings	Regularly (daily, weekly, monthly)
Recovery Tests	Ensures data can be restored effectively and within required timeframes.	– Test recovery time and point objectives (RTO and RPO) – Define and test various recovery scopes – Schedule tests to avoid business disruption – Document all tests and results	Regularly (quarterly, biannually, annually)
Disaster Recovery Tests	Ensures the disaster recovery plan is effective and feasible.	– Perform disaster recovery scenarios – Test failover and failback operations – Coordinate with all relevant teams and stakeholders	Less frequent (once or twice a year)

By incorporating backup and recovery testing into the data lifecycle, organizations can have confidence in their ability to recover data with integrity, minimizing the risk of data loss or corruption and ensuring business continuity in the face of disasters or data loss incidents.

Aspect	Backup Tests	Recovery Tests
Objective	Verify data integrity and backup processes	Ensure data and systems can be successfully restored
Focus	Data backup and storage	Comprehensive recovery of data, applications, and infrastructure
Processes	Data copy verification, consistency checks, storage verification	Full system restore, spot-checking, disaster simulation
Scope	Data-focused	Broader scope including systems and infrastructure
Frequency	Regular intervals (daily, weekly, monthly)	Less frequent but more thorough
Testing Areas	Backup scheduling, data transfer, storage capacity	Recovery time objectives (RTO), recovery point objectives (RPO), failover/failback
Validation	Backup data is complete and accessible	Restored data and systems are fully functional

Risk Based Thinking

Risk-based thinking is a crucial component of modern quality management systems and consists of four key aspects: anticipate, monitor, respond, and learn. Each aspect ensures an organization can effectively manage and mitigate risks, enhancing overall performance and reliability.

Anticipate

Anticipating risks involves proactively identifying and analyzing potential risks that could impact the organization’s operations or objectives. This step is about foreseeing problems before they occur and planning how to address them. It requires a thorough understanding of the organization’s processes, the external and internal factors that could affect these processes, and the potential consequences of various risks. By anticipating risks, organizations can prepare more effectively and prevent many issues from occurring.

Monitor

Monitoring involves continuously observing and tracking the operational environment to detect risk indicators early. This ongoing process helps catch deviations from expected outcomes or standards, which could indicate the emergence of a risk. Effective monitoring relies on establishing metrics that help to quickly and accurately identify when things are starting to veer off course. This real-time data collection is crucial for enabling timely responses to potential threats.

Respond

Responding to risks is about taking appropriate actions to manage or mitigate identified risks based on their severity and potential impact. This step involves implementing the planned risk responses that were developed during the anticipation phase. The effectiveness of these responses often depends on the speed and decisiveness of the actions taken. Responses can include adjusting processes, reallocating resources, or activating contingency plans. The goal is to minimize the organization’s and its stakeholders’ negative impact.

Learn

Learning from the management of risks is a critical component that closes the loop of risk-based thinking. This aspect involves analyzing the outcomes of risk responses and understanding what worked well and what did not. Learning from these experiences is essential for continuous improvement. It helps organizations refine risk management processes, improve response strategies, and better prepare for future risks. This iterative learning process ensures that risk management efforts are increasingly effective over time.

The four aspects of risk-based thinking—anticipate, monitor, respond, and learn—form a continuous cycle that helps organizations manage uncertainties proactively. This approach protects the organization from potential downsides and enables it to seize opportunities that arise from a well-understood risk landscape. Organizations can enhance their resilience and adaptability by embedding these practices into everyday operations.

Implementing Risk-Based Thinking

1. Understand the Concept of Risk-Based Thinking

Risk-based thinking involves a proactive approach to identifying, analyzing, and addressing risks. This mindset should be ingrained in the organization’s culture and used as a basis for decision-making.

2. Identify Risks and Opportunities

Identify potential risks and opportunities. This can be achieved through various methods such as SWOT analysis, brainstorming sessions, and process mapping. It’s crucial to involve people at all levels of the organization since they can provide diverse perspectives on potential risks and opportunities.

3. Analyze and Prioritize Risks

Once risks and opportunities are identified, they should be analyzed to understand their potential impact and likelihood. This analysis will help prioritize which risks need immediate attention and which opportunities should be pursued.

4. Plan and Implement Responses

After prioritizing, develop strategies to address these risks and opportunities. Plans should include preventive measures for risks and proactive steps to seize opportunities. Integrating these plans into the organization’s overall strategy and daily operations is important to ensure they are effective.

5. Monitor and Review

Implementing risk-based thinking is not a one-time activity but an ongoing process. Regular monitoring and reviewing of risks, opportunities, and the effectiveness of responses are crucial. This can be done through regular audits, performance evaluations, and feedback mechanisms. Adjustments should be made based on these reviews to improve the risk management process.

6. Learn and Improve

Organizations should learn from their experiences in managing risks and opportunities. This involves analyzing what worked well and what didn’t and using this information to improve future risk management efforts. Continuous improvement should be a key goal, aligning with the Plan-Do-Check-Act (PDCA) cycle.

7. Documentation and Compliance

Maintaining proper documentation is essential for tracking and managing risk-based thinking activities. Documents such as risk registers, action plans, and review reports should be updated and readily available.

8. Training and Culture

Training and cultural adaptation are necessary to implement risk-based thinking effectively. All employees should be trained on the principles of risk-based thinking and how to apply them in their roles. Creating a culture encouraging open communication about risks and supporting risk-taking within defined limits is also vital.

Business Continuity Planning

The pharmaceutical regulations call, repeatedly for business continuity plans. For example, the FDA calls for fairly significant requirements for Medically Necessary Products:

Medically necessary drug products and their components are manufactured all over the world. An emergency situation anywhere in the world thus might affect the availability of drug products in the United States and result in drug shortages. Emergency preparedness for situations that could result in high employee absenteeism is an important goal for manufacturers of drug products and their components. For example, in an influenza pandemic, widespread human outbreaks of illness would be expected in the United States and around the world, resulting in widespread high absenteeism that could hinder normal production activities and cause shortages in the supply of drug products, packaging materials, and drug components. It is therefore vital for industry to prepare before an emergency situation occurs and to develop plans to ensure continuity of operations during emergencies (including, for example, an influenza pandemic, natural disaster, or personnel issue) that would prevent a significant portion of the work force from reporting. It is especially important for manufacturers of finished drug products to be aware of their suppliers’ and contractors’ responses to personnel shortages and, when appropriate, work with them to ensure the availability of high quality materials and services that contribute to the manufacture of MNPs.
FDA, Guidance for Industry Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products

You can find less definitive requirements throughout the various health authorities’ regulations and guidances.

So what do we mean by business continuity?

Business continuity is the holistic management process that ensures operations continue and that products and services are delivered at predefined levels (e.g. no shortages, no halt to an ongoing clinical trial). This approach is aligned with ISO 22301 Business Continuity Management Systems.

Business continuity management is an ongoing process based on the plan-do-check-act methodology that is made up of 4 key elements:

Emergency Action and Response Plans
Disaster Recovery Plans
Crisis Management Plans
Business Continuity Plans

Emergency Action Plans

An emergency action plan is designed to respond to an emergency with mitigating procedures to protect, secure and evacuate people to safety. This is more an OSHA thing; chances are your average Quality unit doesn’t end up owning it. Unless you have no HS&E unit, and then you write one.

This plan includes procedures for detecting, warning, and responding to specific potential emergencies such as fire, severe weather, earthquake, medical emergencies, workplace violence, and other potential threats.

Disaster Recovery Plan

Disaster recovery plans are designed to recover from a disaster, usually related to equipment, infrastructure, and information technology. Something big goes boom, how do you restore this vital support system or equipment as soon as possible and minimize downtime and loss of data. Very important for computer system lifecycle, disaster recovery plans should include specific plans for recovery functions, resumption strategies, critical personnel, equipment, services, and external and internal communications.

Crisis Management Plans

Crisis management is all about planning and mitigating situations that have risk, and are usually a lot of management of communications internally and externally. This includes with regulators, health care providers, etc. When we implement SOPs for health authority notifications we are engaging in crisis management planning.

Business Continuity Plans

Business continuity planning identifies and plans for disasters to events that could negatively an organization’s business functions, objectives, income, reputation, and ultimate survival. This planning takes place in advance of the potential disasters or events that could harm an organization. It takes potential disasters and events into consideration with their effects on suppliers, vendors customers, and the organization’s other stakeholders.

In a GxP environment, we are looking at the potential impact of disasters on drug supply and clinical study outcomes (amongst other key activities).

The BCP is all about minimizing the effects of the disaster or event on the organization and returning to normal operations as soon as possible.

These Plans are Interrelated

All four plans are interrelated and should be coordinated. The plans can be combined, but as there are usually very different owners they are often separated.

Documented Plans

The business continuity planning process should result in formal, documented plans that serve as a reference guide in the event of a disaster or event. The existence of the business continuity plans should be well communicated, with individuals with responsibilities having ready access and additional training.

Applying the Risk Management Process

The Business Continuity process should leverage existing risk assessments and sit around it.

Select Team

The team should be multifunctional and very knowledgeable about the organization’s business and the risks it faces. This should be a permanent team, not ad hoc, as this is a living process. You can always bring in ad hoc members for specific questions.

Define Context, Purpose, Scope

At a minimum you are tackling the disruption to product supply and cessation of critical GxP data but there may be other business requirements to tackle. Make sure everyone agrees on these.

Define Terminology

Make sure everyone is on the same page with just what disaster, event, crisis, stakeholder, and business continuity plan (and other important concepts) are.

Agree on the scales for likelihood and severity.

Critical Function Assessment

Identify the business functions that are sensitive to downtime, fulfill regulatory obligations and are vital for maintaining product supply.

Threat Assessment

Identify the threats to the performance of the critical functions.

Identify Hazards and Risks

There are three major categories of hazards:

Natural Hazards
- Meteorological
- Geological
- Biological
Human-Caused Hazards
- Accidents
- Intentional acts
Technological Hazards
- Information technology
- Utility
- Fire/explosion
- Hazardous material
- Supply Chain interruption

Utilize a risk matrix to assess the likelihood and severity of the identified hazards and risks.

Develop Business Continuity Plan(s)

After the hazards and risks have been identified, the impact understood and the risks assessed it is time to develop the business continuity plan (BCP). The BCP allows the organziation to survive the event or disaster with minimal disruption. The BCP focuses on mitigating the consequences of the event or disaster that could not be prevented. Recovery strategies for these cosnequences are determined, developed and become part of the BCP.

When many potential risks have been identified, use the risk score to prioritize.

BCPs cover management commitment, team ientification, team responsibilities, mitigation plans, recovery strategies, training, testing and evaluation and continious improvement. Basically the same thing any good plan does.

Mitigation plans are intended to lessen the negative effectis of an event or disaster.

Provide appropriate awareness training to everyone impacted, with more substantial trining to the BCP team.

Verify it periodically and ensure it is continues to be relevant.

Whenever relevant, procceduralize these BCP instructions.