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
What you receive
What's included in a 21 CFR Part 11 assessment?
Every engagement produces structured, traceable evidence - not just a checklist - that holds up when an FDA or EU GMP inspector asks how each control was verified.
Part 11 Gap Assessment Report
Requirement-by-requirement findings mapped to each system, ranked by compliance and data-integrity risk.
Audit Trail Verification Record
Evidence that audit trails capture the required who/what/when for every regulated record, with gaps flagged individually.
Electronic Signature Review
Confirmation that signature manifestation, uniqueness and record linkage meet Part 11 §11.50-§11.70.
Remediation Roadmap
Prioritized, dated action plan covering procedures, system configuration, validation evidence and governance - scoped so your team knows what to fix first.
Methodology
How does PHARPRO scope a Part 11 assessment?
The same founder-led, evidence-first approach used across PHARPRO's CSV and QA engagements: intended use and data risk first, checklist compliance second. A typical assessment runs 2-4 weeks depending on system count and complexity, starting with a remote evidence review before any on-site work is scoped. For system-level validation evidence beyond Part 11 scope, see Computerized System Validation; for wider audit-trail and access-control requirements under EU GMP, see the EU GMP Annex 11 Compliance Checklist.
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 CheckMore questions
What does a 21 CFR Part 11 gap assessment cover?
Electronic records and signatures, audit trails, user access, security, procedures, validation evidence, retention and operational practices.
Can PHARPRO support remote Part 11 assessments?
Yes. Remote evidence review is available, with onsite support across the Middle East when required.
Does Part 11 compliance require validation?
Validation and appropriate procedural and technical controls are central when regulated organizations rely on electronic systems for GxP records or signatures.