Data integrity assessment and remediation
Worried about data integrity findings in your next inspection? A fixed-scope review of your GxP data integrity posture. It ends in a gap report and a remediation plan, so you find the exposure before an inspector does.
The challenges this solves
Shared logins and missing audit trails
These are common causes of 483s and warning letters, and we are not sure we have none.
Spreadsheets and hybrid records
Uncontrolled Excel files and paper-to-electronic transcription are hard to defend.
Expectations are tightening
The draft Annex 11 revision requires quality risk management across the system lifecycle.
What we deliver
- ALCOA++ review across systems: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available
- Audit-trail design and review practice
- Access and identity controls: unique accounts, role segregation, no shared logins, e-signature integrity
- Spreadsheets and hybrid records, including uncontrolled Excel and paper-to-electronic transcription
- Backup, archive and retention
- Governance and SOPs: policy, training and procedures
4 steps, clear deliverables
- 01
Scope
Agree the systems, records and timeframe.
You receive: Agreed scope
- 02
Assess
Document review, system walkthroughs and control testing.
You receive: System-by-system gap analysis and ALCOA++ scorecard
- 03
Report
Rate findings by patient or product risk and inspection exposure.
You receive: Risk-rated findings and board-ready summary
- 04
Remediate
Deliver prioritized fixes as a separate, scoped follow-on.
You receive: Sequenced roadmap of quick wins and structural fixes
Want to know what this would take for your systems? Start with a short scoping call.
Who we do this for
- Pharma & biopharma
- Biotech
- Medical devices
- Cell & gene therapy
- CROs & clinical
Related services
Questions we hear most
What standard do you assess against?
We assess to FDA and EMA investigator standards, including 21 CFR Part 11, EU Annex 11 and the draft Annex 11 revision.
What drives the price?
The number of systems in scope. Each engagement has a defined price and timeline, with no open-ended hourly billing.
Is remediation part of the assessment?
No. Remediation is a separate, scoped engagement. The roadmap splits quick wins from structural fixes, with effort estimates.
Know your data integrity exposure
Get a fixed-fee assessment before your next inspection.