Writing user requirements that simply state “the system shall meet FDA 21 CFR Part 11 requirements” or “the system shall comply with EU Annex 11” is fundamentally bad practice. These high-level regulatory statements create ambiguity, shift responsibility inappropriately, and fail to provide the specific, testable criteria that effective requirements demand.

Crafting Good User Requirements

The Core Problem: Regulatory References Aren’t Technical Requirements

User requirements must be specific, measurable, and testable. When we write “the system shall meet Annex 11 and Part 11 requirements,” we’re not writing a technical requirement at all—we’re writing a reference to a collection of regulatory provisions that may or may not apply to our specific system context. This creates several fundamental problems that undermine the entire validation and verification process.

The most critical issue is ambiguity of technical scope. Annex 11 and Part 11 contains numerous provisions, but not all apply to every system. Some provisions address closed systems, others open systems. Some apply only when electronic records replace paper records, others when organizations rely on electronic records to perform regulated activities. Without specifying which technical provisions apply and how they translate into system functionality, we leave interpretation to individual team members—a recipe for inconsistent implementation.

Technical verification becomes impossible with such high-level statements. How does a tester verify that a system “meets Part 11”? They would need to become regulatory experts, interpret which provisions apply, translate those into testable criteria, and then execute tests—work that should have been done during requirements definition. This shifting of analytical responsibility from requirements authors to testers violates fundamental engineering principles.

Why This Happens: The Path of Least Resistance

The temptation to write high-level regulatory requirements stems from several understandable but misguided motivations. Requirements authors often lack deep regulatory knowledge and find it easier to reference entire regulations rather than analyze which specific technical provisions apply to their system. This approach appears comprehensive while avoiding the detailed work of regulatory interpretation.

Time pressure exacerbates this tendency. Writing “meet Part 11” takes minutes; properly analyzing regulatory requirements, determining technical applicability, and translating them into specific, testable statements takes days or weeks. Under project pressure, teams often choose the quick path without considering downstream consequences.

There’s also a false sense of completeness. Referencing entire regulations gives the impression of thorough coverage when it actually provides no technical coverage at all. It’s the requirements equivalent of writing “the system shall work properly”, technically correct but utterly useless for implementation or testing purposes.

Better Approach: Technical User Requirements

Effective regulatory user requirements break down high-level regulatory concepts into specific, measurable technical statements that directly address system functionality. Rather than saying “meet Part 11,” we need requirements that specify exactly what the system must do technically.

Access Control Requirements

Instead of: “The system shall meet Part 11 access control requirements”

Write:

• “The system shall authenticate users through unique user ID and password combinations, where each combination is assigned to only one individual”
• “The system shall automatically lock user sessions after 30 minutes of inactivity and require re-authentication”
• “The system shall maintain an electronic log of all user authentication attempts, including failed attempts, with timestamps and user identifiers”

Electronic Record Generation Requirements

Instead of: “The system shall generate Part 11 compliant electronic records”

Write:

• “The system shall generate electronic records that include all data required by the predicate rule, with no omission of required information”
• “The system shall time-stamp all electronic records using computer-generated timestamps that cannot be altered by system users”
• “The system shall detect and flag any unauthorized alterations to electronic records through checksum validation”

Audit Trail Requirements

Instead of: “The system shall maintain Part 11 compliant audit trails”

Write:

• “The system shall automatically record the user ID, date, time, and type of action for all data creation, modification, and deletion operations”
• “The system shall store audit trail records in a format that prevents user modification or deletion”
• “The system shall provide audit trail search and filter capabilities by user, date range, and record type”

Electronic Signature Requirements

Instead of: “The system shall support Part 11 electronic signatures”

Write:

• “Electronic signature records shall include the signer’s printed name, date and time of signing, and the purpose of the signature”
• “The system shall verify signer identity through authentication requiring both user ID and password before accepting electronic signatures“
• “The system shall cryptographically link electronic signatures to their associated records to prevent signature transfer or copying”

Annex 11 Technical Examples

EU Annex 11 requires similar technical specificity but with some European-specific nuances. Here are better technical requirement examples:

System Security Requirements

Instead of: “The system shall meet Annex 11 security requirements”

Write:

• “The system shall implement role-based access control where user privileges are assigned based on documented job responsibilities”
• “The system shall encrypt all data transmission between system components using AES 256-bit encryption”
• “The system shall maintain user session logs that record login time, logout time, and all system functions accessed during each session”

Data Integrity Requirements

Instead of: “The system shall ensure Annex 11 data integrity”

Write:

• “The system shall implement automated backup procedures that create complete system backups daily and verify backup integrity”
• “The system shall prevent simultaneous modification of the same record by multiple users through record locking mechanisms”
• “The system shall maintain original raw data in unalterable format while allowing authorized users to add comments or corrections with full audit trails”

System Change Control Requirements

Instead of: “The system shall implement Annex 11 change control”

Write:

• “The system shall require authorized approval through electronic workflow before implementing any configuration changes that affect GMP functionality”
• “The system shall maintain a complete history of all system configuration changes including change rationale, approval records, and implementation dates”
• “The system shall provide the ability to revert system configuration to any previous approved state through documented rollback procedures”

The Business Case for Technical Requirements

Technical requirements save time and money. While writing detailed requirements requires more upfront effort, it prevents costly downstream problems. Clear technical requirements eliminate the need for interpretation during design, reduce testing iterations, and prevent regulatory findings during inspections.

Technical traceability becomes meaningful when requirements are specific. We can trace from business needs through technical specifications to test cases and validation results. This traceability is essential for regulatory compliance and change control.

System quality improves systematically when everyone understands exactly what technical functionality needs to be built and tested. Vague requirements lead to assumption-driven development where different team members make different assumptions about what’s technically needed.

Implementation Strategy for Technical Requirements

Start by conducting regulatory requirement analysis as a separate technical activity before writing user requirements. Identify which regulatory provisions apply to your specific system and translate them into technical functionality. Document this analysis and use it as the foundation for technical requirement writing.

Engage both regulatory and technical experts early in the requirements process. Don’t expect requirements authors to become overnight regulatory experts, but do ensure they have access to both regulatory knowledge and technical understanding when translating regulatory concepts into system requirements.

Use technical requirement templates that capture the essential technical elements of common regulatory requirements. This ensures consistency across projects and reduces the analytical burden on individual requirements authors.

Review requirements for technical testability. Every requirement should have an obvious technical verification method. If you can’t immediately see how to test a requirement technically, it needs to be rewritten.

Technical Requirements That Actually Work

High-level regulatory references have no place in technical user requirements documents. They create technical ambiguity where clarity is needed, shift analytical work to inappropriate roles, and fail to provide the specific technical guidance necessary for successful system implementation.

Better technical requirements translate regulatory concepts into specific, measurable, testable statements that directly address system technical functionality. This approach requires more upfront effort but delivers better technical outcomes: clearer system designs, more efficient testing, stronger regulatory compliance, and systems that actually meet user technical needs.

The pharmaceutical industry has matured beyond accepting “it must be compliant” as adequate technical guidance. Our technical requirements must mature as well, providing the specific, actionable technical direction that modern development teams need to build quality systems that truly serve patients and regulatory expectations.

As I’ve emphasized in previous posts about crafting good user requirements and building FUSE(P) user requirements, technical specificity and testability remain the hallmarks of effective requirements writing. Regulatory compliance requirements demand this same technical rigor—perhaps more so, given the patient safety implications of getting the technical implementation wrong.