Part 11 Gap Assessment
Requirement-by-requirement review of system use, procedures, validation evidence and technical controls.
Electronic records & signatures
21 CFR Part 11 Consulting Across the Middle East
Identify and close compliance gaps in electronic records, audit trails, electronic signatures, access controls and computerized system validation.
PHARPRO provides founder-led 21 CFR Part 11 consulting in the Middle East for pharmaceutical and life-sciences organizations in Jordan, UAE, Saudi Arabia and wider MENA. Every assessment is tied to intended use, data risk and defensible evidence.
FDA 21 CFR Part 11EU GMP Annex 11ISPE GAMP 5ALCOA+
Assessment scope
From gap assessment to inspection-ready remediation
A practical service for new implementations, legacy remediation, pre-inspection reviews and supplier-hosted systems.
Audit Trails & Data Integrity
Assess audit-trail generation, review, retention, time stamps, changes and ALCOA+ controls.
Electronic Signatures
Review identity, uniqueness, signature manifestation, record linkage and procedural governance.
Access & Security
Evaluate roles, privileges, account lifecycle, segregation of duties and administrator oversight.
CSV Evidence
Connect intended use and risk to URS, configuration, testing, traceability and release decisions.
Remediation Roadmap
Prioritized actions covering procedures, configuration, validation, supplier evidence and governance.
Systems covered
Part 11 support for regulated systems and digital projects
Suitable for systems that create, modify, maintain, archive, retrieve or transmit regulated electronic records.
- ERP, LIMS, QMS and DMS
- Laboratory instruments and software
- Manufacturing and facility systems
- Spreadsheets and configured tools
- SaaS and cloud platforms
- Electronic approval workflows
Frequently asked questions
21 CFR Part 11 consulting FAQs
What does a Part 11 gap assessment cover?
Electronic records and signatures, audit trails, access, security, procedures, validation, retention and actual operational practices.
Can the assessment be completed remotely?
Yes. PHARPRO supports remote evidence review and interviews, with onsite work available across the Middle East.
Will we receive a practical remediation plan?
Yes. Findings are prioritized by compliance and data risk with clear actions for configuration, procedures, validation and governance.
Make your electronic records defensible before the inspection.
Start with a focused fit check and identify the next practical decision for your system or remediation program.
Book a Free Fit Check