Annex 11 Section 5.1 “Cooperation”—The Real Test of Governance and Project Team Maturity

The draft Annex 11 is a cultural shift, a new way of working that reaches beyond pure compliance to emphasize accountability, transparency, and full-system oversight. Section 5.1, simply titled: “Cooperation” is a small but might part of this transformation

On its face, Section 5.1 may sound like a pleasantry: the regulation states that “there should be close cooperation between all relevant personnel such as process owner, system owner, qualified persons and IT.” In reality, this is a direct call to action for the formation of empowered, cross-functional, and highly integrated governance structures. It’s a recognition that, in an era when computerized systems underpin everything from batch release to deviation investigation, a siloed or transactional approach to system ownership is organizational malpractice.

Governance: From Siloed Ownership to Shared Accountability

Let’s breakdown what “cooperation” truly means in the current pharmaceutical digital landscape. Governance in the Annex 11 context is no longer a paperwork obligation but the backbone for digital trust. The roles of Process Owner (who understands the GMP-critical process), System Owner (managing the integrity and availability of the system), Quality (bearing regulatory release or oversight risk), and the IT function (delivering the technical and cybersecurity expertise) all must be clearly defined, actively engaged, and jointly responsible for compliance outcomes.

This shared ownership translates directly into how organizations structure project teams. Legacy models—where IT “owns the system,” Quality “owns compliance,” and business users “just use the tool”—are explicitly outdated. Section 5.1 obligates that these domains work in seamless partnership, not simply at “handover” moments but throughout every lifecycle phase from selection and implementation to maintenance and retirement. Each group brings indispensable knowledge: the process owner knows process risks and requirements; the system owner manages configuration and operational sustainability; Quality interprets regulatory standards and ensure release integrity; IT enables security, continuity, and technical change.

Practical Project Realities: Embedding Cooperation in Every Phase

In my experience, the biggest compliance failures often do not hinge on technical platform choices, but on fractured or missing cross-functional cooperation. Robust governance, under Section 5.1, doesn’t just mean having an org chart—it means everyone understands and fulfills their operational and compliance obligations every day. In practice, this requires formal documents (RACI matrices, governance charters), clear escalation routes, and regular—preferably, structured—forums for project and system performance review.

During system implementation, deep cooperation means all stakeholders are involved in requirements gathering and risk assessment, not just as “signatories” but as active contributors. It is not enough for the business to hand off requirements to IT with minimal dialogue, nor for IT to configure a system and expect the Qulity sign-off at the end. Instead, expect joint workshops, shared risk assessments (tying from process hazard analysis to technical configuration), and iterative reviews where each stakeholder is empowered to raise objections or demand proof of controls.

At all times, communication must be systematic, not ad hoc: regular governance meetings, with pre-published minutes and action tracking; dashboards or portals where issues, risks, and enhancement requests can be logged, tracked, and addressed; and shared access to documentation, validation reports, CAPA records, and system audit trails. This is particularly crucial as digital systems (cloud-based, SaaS, hybrid) increasingly blur the lines between “IT” and “business” roles.

Training, Qualifications, and Role Clarity: Everyone Is Accountable

Section 5.1 further clarifies that relevant personnel—regardless of functional home—must possess the appropriate qualifications, documented access rights, and clearly defined responsibilities. This raises the bar on both onboarding and continuing education. “Cooperation” thus demands rotational training and knowledge-sharing among core team members. Process owners must understand enough of IT and validation to foresee configuration-related compliance risks. IT staff must be fluent in GMP requirements and data integrity. Quality must move beyond audit response and actively participate in system configuration choices, validation planning, and periodic review.

In my own project experience, the difference between a successful, inspection-ready implementation and a troubled, remediation-prone rollout is almost always the presence, or absence, of this cross-trained, truly cooperative project team.

Supplier and Service Provider Partnerships: Extending Governance Beyond the Walls

The rise of cloud, SaaS, and outsourced system management means that “cooperation” extends outside traditional organizational boundaries. Section 5.1 works in concert with supplier sections of Annex 11—everyone from IT support to critical SaaS vendors must be engaged as partners within the governance framework. This requires clear, enforceable contracts outlining roles and responsibilities for security, data integrity, backup, and business continuity. It also means periodic supplier reviews, joint planning sessions, and supplier participation in incidents and change management when systems span organizations.

Internal IT must also be treated with the same rigor—a department supporting a GMP system is, under regulation, no different than a third-party vendor; it must be a named party in the cooperation and governance ecosystem.

Oversight and Monitoring: Governance as a Living Process

Effective cooperation isn’t a “set and forget”—it requires active, joint oversight. That means frequent management reviews (not just at system launch but periodically throughout the lifecycle), candid CAPA root cause debriefs across teams, and ongoing risk and performance evaluations done collectively. Each member of the governance body—be they system owner, process owner, or Quality—should have the right to escalate issues and trigger review of system configuration, validation status, or supplier contracts.

Structured communication frameworks—regularly scheduled project or operations reviews, joint documentation updates, and cross-functional risk and performance dashboards—turn this principle into practice. This is how validation, data integrity, and operational performance are confidently sustained (not just checked once) in a rigorous, documented, and inspection-ready fashion.

The “Cooperation” Imperative and the Digital GMP Transformation

With the explosion of digital complexity—artificial intelligence, platform integrations, distributed teams—the management of computerized systems has evolved well beyond technical mastery or GMP box-ticking. True compliance, under the new Annex 11, hangs on the ability of organizations to operationalize interdisciplinary governance. Section 5.1 thus becomes a proxy for digital maturity: teams that still operate in silos or treat “cooperation” as a formality will be missed by the first regulatory deep dive or major incident.

Meanwhile, sites that embed clear role assignment, foster cross-disciplinary partnership, and create active, transparent governance processes (documented and tracked) will find not only that inspections run smoothly—they’ll spend less time in audit firefighting, make faster decisions during technology rollouts, and spot improvement opportunities early.

Teams that embrace the cooperation mandate see risk mitigation, continuous improvement, and regulatory trust as the natural byproducts of shared accountability. Those that don’t will find themselves either in chronic remediation or watching more agile, digitally mature competitors pull ahead.

Key Governance and Project Team Implications

To provide a summary for project, governance, and operational leaders, here is a table distilling the new paradigm:

Governance Aspect	Implications for Project & Governance Teams
Clear Role Assignment	Define and document responsibilities for process owners, system owners, and IT.
Cross-Functional Partnership	Ensure collaboration among quality, IT, validation, and operational teams.
Training & Qualification	Clarify required qualifications, access levels, and competencies for personnel.
Supplier Oversight	Establish contracts with roles, responsibilities, and audit access rights.
Proactive Monitoring	Maintain joint oversight mechanisms to promptly address issues and changes.
Communication Framework	Set up regular, documented interaction channels among involved stakeholders.

In this new landscape, “cooperation” is not a regulatory afterthought. It is the hinge on which the entire digital validation and integrity culture swings. How and how well your teams work together is now as much a matter of inspection and business success as any technical control, risk assessment, or test script.

The Challenges Ahead for Quality

Discussions about Industry 4.0 and Quality 4.0 often focus on technology. However, technology is just one of the challenges that Quality organizations face. Many trends are converging to create constant disruption for businesses, and the Quality unit must be ready for these changes. Rapid changes in technology, work, business models, customer expectations, and regulations present opportunities to improve quality management but also bring new risks.

The widespread use of digital technology has raised the expectations of stakeholders beyond what traditional quality management can offer. As the lines between companies, suppliers, and customers become less distinct, the scope of quality management must expand beyond the traditional value chain. New work practices, such as agile teams and remote work, are creating challenges for traditional quality management governance and implementation strategies. To remain relevant, Quality leaders must adapt to these changes..

The traditional Value Proposition of quality management is no longer sufficient to meet the expectations of stakeholders. With the rise of a digitally native workforce, there are new expectations for how work is done and managed. Business leaders expect quality leaders to have full command of operational data, diagnosing and anticipating quality problems. Regulators also expect high data transparency and traceability.

The value proposition of quality management lies in predicting problems rather than reacting to them. The primary objective of quality management should be to find hidden value by addressing the root causes of quality issues before they manifest. Quality organizations who can anticipate and prevent operational problems will meet or exceed stakeholder expectations.

Our organizations are on a journey towards utilizing predictive capabilities to unlock value, rather than one that retroactively solves problems. Our scope needs to be based on quality being predictive, connected, flexible, and embedded. For me this is the heart of Qualty 4.0.

Quality management should be applied across a multitude of systems, devices, products, and partners to create a seamless experience. This entails transforming quality from a function into an interdisciplinary, participatory process. The expanded scope will reach new risks in an increasingly complex ecosystem. The Quality unit cannot do this on its own; it’s all about breaking down silos and building autonomy within the organization.

To achieve this transformation, we need to challenge ourselves to move beyond top-down and regimented Governance Models and Implementation Strategies. We need to balance our core quality processes and workflows to achieve repeatability and consistency while continually adjusting as situations evolve. We need to build autonomy, critical thinking, and risk-based thinking into our organizational structures.

One way to achieve this is by empowering end-users to solve their own quality challenges through participatory quality management. This encourages personal buy-in and enables quality governance to adapt in real-time to different ways of working. By involving end-users in the process of identifying and solving quality issues, we can build a culture of continuous improvement and foster a sense of ownership over the quality of our products and services.

The future of quality management lies in being predictive, connected, flexible, and embedded.

Predictive: The value proposition of quality management needs to be predicting problems over problem-solving.
Connected: The scope of quality management needs to extend beyond the value chain and connect across the ecosystem
Flexible: The governance model needs to be based on an open-source model, rather than top-down.
Embedded: The implementation strategy needs to shift from viewing quality as a role to quality as a skill.

By embracing these principles and involving all stakeholders in the process of continuous improvement, we can unlock hidden value and exceed stakeholder expectations.

Deaing with these challenges and implications requires the Quality organization to treat transformation like a Program. This program should have four main initiative areas:

Build the capacity for targeted prevention through targeted data insights. This includes building alliances with IT and other teams to have the right data available in flexible ways but it also includes the building of capacity to actually use the data.
Expand quality management to cover the entire value network.
Localize Risk Management to Make Quality Governance Flexible and Open Source.
Distribute Tasks and Knowledge to Embed Quality Management in the Business.

Across these pillars the program approach will:

Assess the current state: Identify areas requiring attention and improvement by examining existing People, Processes, Policies and Platforms. This comprehensive assessment will provide a clear understanding of the organization’s current situation and help pinpoint areas where projects can have the most significant impact
Establish clear objectives: Establish clear objectives to h provide a clear roadmap for success.
Prioritize foundational elements: Prioritize building foundational elements. Avoid bells-and-whistles for their own sake.
Develop a phased approach: This is not an overnight process. Develop a phased approach that allows for gradual implementation, with clear milestones and measurable outcomes. This ensures that the organization can adapt and adjust as needed while maintaining ongoing operations and minimizing disruptions.
Collaborate with stakeholders: Engage stakeholders from across the organization,to ensure alignment and buy-in. Create a shared vision for the initiative to ensure that everyone is working towards the same goals. Regular communication and collaboration among stakeholders will foster a sense of ownership and commitment to the transformation process.
Continuously monitor progress: Regularly review the progress, measuring outcomes against predefined objectives. This enables organizations to identify any potential issues or roadblocks and make adjustments as necessary to stay on track. Establishing key performance indicators (KPIs) will help track progress and determine the effectiveness of the Program.
Embrace a culture of innovation: Encourage a culture that embraces innovation and continuous improvement. This helps ensure that the organization remains agile and adaptive, making it better equipped to take advantage of new technologies and approaches as they emerge. Fostering a culture of innovation will empower employees to seek out new ideas and solutions, driving long-term success.
Invest in employee training and development: It is crucial to provide employees with the necessary training and development opportunities to adapt to new technologies and processes. This will ensure that employees are well-equipped to handle the changes brought about by these challenges and contribute to the organization’s overall success.
Evaluate and iterate: As the Program unfolds, it is essential to evaluate the results of each phase and make adjustments as needed. This iterative approach allows organizations to learn from their experiences and continuously improve their efforts, ultimately leading to greater success.

To do this leverage the eight accelerators to change.

Challenge	Means	Impact to Quality Management	How to Prepare
Advanced Analytics	The increase in data sources and improved data processing has led to higher expectations from customers, regulators, business leaders, and employees. They expect companies to use data analytics to provide advanced insights and improve decision-making.	Requires a holistic approach that allows quality professionals to access, analyze and apply insights from structured and unstructured data Quality excellence will be determined by how quickly data can be captured, analyzed, shared and applied	Develop a talent strategy to recruit, develop, rent or borrow individuals with data analytics capabilities, such as data science, coding and data visualization
Hyper-Automation	To become more efficient and agile in a competitive market, companies will increasingly use technologies like RPA, AI, and ML. These technologies will automate or enhance tasks that were previously done by humans. In other words, if a task can be automated, it will be.	How to ensure these systems meet intended use and all requirements Algorithm-error-generated root causes	Develop a hyperautomation vision for quality management that highlights business outcomes and reflects the use cases of relevant digital technology Perform a risk-based assessment with appropriate experts to identify critical failure points in machine and algorithm decision making
Virtualization of Work	The shift to remote work due to COVID-19, combined with advancements in cloud computing and AR/VR technology, will make work increasingly digital.	Rethink how quality is executed and governed in a digital environment.	Evaluate current quality processes for flexibility and compatibility with virtual work and create an action plan. Uncover barriers to driving a culture of quality in a virtual working environment and incorporate virtual work-relevant objectives, metrics and activities into your strategy.
Shift to Resilient Operations	Prioritizing capabilities that improve resilience and agility.	Adapt in real-time to changing and simultaneously varying levels of risk without sacrificing the core purpose of Quality	Enable employees to make faster decisions without sacrificing quality by developing training to build quality-informed judgment and embedding quality guidance in employee workflows. Identify quality processes that may prevent operational resilience and reinvent them by starting from scratch, ruthlessly challenging the necessity of every step and requirement. Ensure employees and new hires have the right skill sets to design, build and operate a responsive network environment.
Rise of Inter-connected Ecosystems	The growth of interconnected networks of people, businesses, and devices allows companies to create value by expanding their systems to include customers, suppliers, partners, and other organizations.	Greater connectivity between customers, suppliers, and partners provides more visibility into the value chain. However, it also increases risk because it can be difficult to understand and manage different views of quality within the ecosystem.	Map out the entire quality management ecosystem model and its participants, as well as their interactions with customers. Co-develop critical-to-quality behaviors with strategic partners. Strengthen relationships with partners across the ecosystem to capture and leverage relevant information and data, while at the same time addressing data privacy concerns.
Digitally Native Workforce	Shift from digital immigrants (my generation and older) to digital natives who are those people who have grown up and are comfortable with computers and the internet. Unlike other generations, digital natives are so used to using technology in all areas of their lives that it is (and always has been) an integral, necessary part of their day-to-day.	Increased flexibility leads to a need to rethink the way we monitor, train, and incentivize quality. Connecting the 4 Ps: People, Processes, Policies and Platforms	Identify and target existing quality processes to digitize to offer desired flexibility. Adjust messages about the importance of quality to connect with values employees care about (e.g., autonomy, innovation, social issues).
Customer Expectation Multiplicity	Customer expectations evolve quickly and expand into new-in-kind areas as access to information and global connectedness increases.	Develop product portfolios, internal processes and company cultures that can quickly adapt to rapidly changing customer expectations for quality.	Identify where hyperautomation and predictive capabilities of quality management can enhance customer experience and prevent issues before they occur.
Increasing Regulatory Complexity	The global regulatory landscape is becoming more complex as countries introduce new regulations at different rates. Increased push for localization.	Need strong system to efficiently implement changes across different systems, locations, and regions while maintaining consistent quality management throughout the ecosystem.	Coordinate a structured regulatory tracking approach to monitor changing regulatory developments — highly regulated industries require a more comprehensive approach compared to organizations in a moderate regulatory environment