Computer system validation and 21 CFR Part 11 compliance
Gap assessments, validation, and SOPs for electronic records and electronic signatures, including platforms like DocuSign, LIMS, and data-logging software.
What Part 11 requires
21 CFR Part 11 sets the conditions under which FDA accepts electronic records and electronic signatures in place of paper and wet ink. In practice that means validated systems, secure and attributable user access, computer-generated audit trails, record retention, and signatures that are uniquely linked to the signer and the record.
We run Part 11 gap assessments against your actual configuration and use, then close the gaps with validation, configuration changes, and procedures.
Right-sized validation
Not every system needs the same depth of testing. Using the risk-based approach in GAMP 5, we scale validation to the system's category, complexity, and impact on product quality and data integrity, and lean on supplier documentation where it is justified.
Data integrity is assessed against the ALCOA+ principles, so records are attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
What we deliver
- 21 CFR Part 11 gap assessments
- Validation plans and system risk assessments
- User and functional requirements
- IQ/OQ/PQ or risk-based test scripts
- Audit trail and access control review
- E-signature SOPs and policies
- Data integrity assessments (ALCOA+)
- Periodic review procedures
Regulations and standards
- 21 CFR Part 11
- GAMP 5
- ISO 22716
- FDA data integrity guidance
- ALCOA+
Common questions
Is DocuSign 21 CFR Part 11 compliant?
No software is compliant on its own. Compliance depends on how the system is configured, validated, and governed by your procedures. An e-signature platform can support Part 11 use when the right controls are enabled and your site SOP defines how signatures are applied and when hand signatures are still required.
Which systems need computer system validation?
Any computerized system used to create, modify, maintain, or transmit GMP records, or that controls a GMP process. Common examples are LIMS, electronic QMS and document systems, data loggers and environmental monitoring software, and automated equipment.
Does Part 11 apply to cosmetics manufacturers?
Part 11 applies to records required by FDA regulations, so it reaches sites making OTC drug products. Cosmetics-only sites working to ISO 22716 often adopt the same controls as good practice and to be ready if their product portfolio changes.
Tell us about your project
Whether it's a single qualification or an audit on the calendar, send a few details and we'll reply within one business day.