In today’s increasingly digital life sciences landscape, maintaining compliance with regulatory standards for electronic records and electronic signatures is paramount. Among these, 21 CFR Part 11 — a regulation issued by the U.S. FDA — stands as a critical benchmark for companies working in pharmaceuticals, biotechnology, medical devices, and clinical research.
But meeting 21 CFR Part 11 requirements isn’t just about checking boxes. It requires building systems that are validated, processes that are traceable, and data that is trustworthy. That’s where GAMP 5 and ALCOA principles come into play — guiding frameworks that support the design, implementation, and governance of compliant, high-quality computerized systems and data integrity processes.
This blog explores how life sciences organizations can ensure 21 CFR Part 11 compliance by applying GAMP 5 and ALCOA+ principles across their operations.
21 CFR Part 11 is a part of the Code of Federal Regulations that sets forth the FDA’s criteria for accepting electronic records and signatures as equivalent to paper records and handwritten signatures. It applies to any FDA-regulated organization that uses electronic systems for GxP (Good Practice) processes — including clinical trials, manufacturing, laboratory operations, and more.
Validation of systems to ensure accuracy, reliability, and consistent intended performance
Audit Trails that are secure, computer-generated, and time-stamped
Record Retention & Retrieval to allow accurate and prompt review
Access Control to ensure only authorized individuals can use the system
Electronic Signatures that are legally binding and traceable
Change Control processes to track and manage updates to software or data
These requirements aim to prevent fraud, ensure accountability, and support data integrity throughout the system lifecycle.
The Good Automated Manufacturing Practice (GAMP 5) framework provides a structured and scalable methodology for validating computerized systems. Developed by the International Society for Pharmaceutical Engineering (ISPE), GAMP 5 focuses on risk-based decision-making and lifecycle management.
Product and Process Understanding – Know the intended use and criticality of the system.
Lifecycle Approach – From concept to retirement, systems should be developed and maintained with compliance in mind.
Scalable Validation – The level of validation should match the system’s complexity and risk.
Supplier Involvement – Leverage vendor documentation and support when possible.
Risk Management – Identify, assess, and mitigate risks throughout the lifecycle.
GAMP 5 Categories of Software:
Category 1: Infrastructure Software
Category 3: Non-configurable Commercial Off-The-Shelf (COTS)
Category 4: Configured Software
Category 5: Custom Applications
By classifying software and following a tailored validation strategy, GAMP 5 allows organizations to avoid over-validation while ensuring compliance.
To maintain compliance with 21 CFR Part 11, data integrity is critical. The ALCOA principles, originally developed by the FDA and now widely adopted by regulatory bodies globally, serve as a guideline for ensuring trustworthy and reliable data.
Attributable – Who performed the action and when?
Legible – Can you read and understand the data?
Contemporaneous – Was it recorded at the time of the activity?
Original – Is it the source record or a certified copy?
Accurate – Is the data correct and complete?
Complete – All data including repeats, reanalysis, and out-of-spec results
Consistent – In chronological order and following expected patterns
Enduring – Recorded in a permanent and durable form
Available – Accessible for review and audit over the data retention period
Applying ALCOA+ ensures not just data integrity but also readiness for audits and inspections.
| 21 CFR Part 11 Requirement | GAMP 5 Contribution | ALCOA+ Contribution |
|---|---|---|
| System Validation | Lifecycle approach, risk-based validation, supplier documentation | Ensures records are accurate, complete, and trustworthy |
| Audit Trails | System design includes audit capabilities; testing during validation | Enables traceability (Attributable, Accurate, Consistent) |
| Access Control | Security and access management as part of system requirements | Ensures data is attributable and protected |
| Electronic Signatures | Defined during requirements/specifications; tested during validation | Signatures are attributable and contemporaneous |
| Change Control | Integrated into lifecycle management and documentation processes | Maintains data consistency and auditability |
Implement a Risk-Based Validation Plan
Use GAMP 5 methodology to prioritize validation efforts based on system complexity and impact on patient safety or product quality.
Design with ALCOA+ in Mind
Ensure that data capture, storage, and access mechanisms are built to enforce ALCOA+ principles from the outset.
Choose Compliant Technology Platforms
Select systems that support 21 CFR Part 11 capabilities out-of-the-box — such as audit trails, role-based access, and electronic signature features.
Train Teams on Data Integrity
Educate end users, QA, and IT personnel on ALCOA+, system usage policies, and the importance of compliant behavior.
Perform Periodic Assessments
Conduct internal audits and gap assessments to identify risks and improve your validation and compliance posture continuously.
Cloudbyz eClinical solutions — including CTMS, EDC, eTMF, and Safety platforms — are natively built on the Salesforce platform, enabling robust GAMP 5-aligned validation, built-in Part 11 features, and full ALCOA+ data integrity support.
Audit-ready electronic signatures and access controls
Comprehensive audit trails and change logs
Cloud infrastructure with configurable workflows
Integrated document lifecycle and metadata management
Validated system documentation aligned with GAMP 5
Our configurable, cloud-based platform accelerates compliance while reducing the burden on internal teams — giving you confidence during regulatory inspections and partner audits.
21 CFR Part 11 compliance isn’t a one-time event — it’s a culture of data integrity, system validation, and continuous improvement. By integrating GAMP 5 best practices and enforcing ALCOA+ principles, life sciences organizations can ensure their electronic records and systems are both compliant and audit-ready.
As regulatory expectations evolve and digital transformation continues, embracing these frameworks will be crucial not only for compliance but also for operational excellence.
Looking to strengthen your compliance posture?
Cloudbyz can help. Contact us today to learn how our validated, cloud-based eClinical solutions support your 21 CFR Part 11 journey.