MHRA GMP · Annex 11 · ALCOA+ · Inspection readiness
Records and controls that support MHRA GMP data integrity expectations.
V5 provides the record controls inspectors look at; your procedures and validation decide compliance.
ALCOA+ pairing
Individual named identity on every action, contemporaneous capture, original values never overwritten, and a tamper-evident audit trail that can be…
Annex 11 Controls Documented
System risk assessment, validation pack, IQ/OQ support on private cloud, access control matrices, periodic review and disaster recovery evidence…
Calculations under Version Control
Potency and moisture corrections, yield and reconciliation are computed by the validated system, with the formula version recorded on the batch — not…
What goes wrong today3 common problems
Data Integrity Findings Come from Spreadsheets and Shared Accounts
Uncontrolled calculations, generic operator logins and unlocked records are the recurring themes in MHRA deficiency letters.
Annex 11 expectations are not met by 'the ERP has an audit trail'
Inspectors ask for risk assessment, validation, access control, audit-trail review and business continuity for each computerised system.
Inspection Preparation Consumes the QA Team
Weeks of assembling batch documentation, deviation histories and training records before every visit.
Everything V5 does here5 capabilities
ALCOA+ pairing
Individual named identity on every action, contemporaneous capture, original values never overwritten, and a tamper-evident audit trail that can be reviewed by exception.
Annex 11 Controls Documented
System risk assessment, validation pack, IQ/OQ support on private cloud, access control matrices, periodic review and disaster recovery evidence supplied as part of deployment.
Calculations under Version Control
Potency and moisture corrections, yield and reconciliation are computed by the validated system, with the formula version recorded on the batch — not typed into a spreadsheet.
Deviations, OOS and CAPA Connected to the Batch
Investigation history is attached to the lot, so a question at the inspection desk is answered in the system rather than from an archive box.
Audit-trail review that a human can actually do
Risk-based review queues surface the entries that matter — changed results, overridden limits, late signatures — instead of asking QA to read everything.
Standards Referenced
- EU GMP Part I / Annex 11 (as retained in UK law)
- MHRA 'GXP' Data Integrity Guidance and Definitions (2018)
- GAMP 5 (2nd edition)
- ICH Q9 / Q10
- 21 CFR Part 11 for dual US-facing sites
Common questions5 answers
- What does the MHRA expect from a computerised system?
- A validated system with documented risk assessment, controlled individual access, contemporaneous and attributable records, a secure audit trail that is reviewed, controlled changes, backup and recovery, and a business continuity arrangement — the Annex 11 set, read alongside the 2018 data integrity guidance.
- Does V5 come with validation documentation?
- Yes. Private-cloud deployments include IQ/OQ support and a validation pack, and V5 Ultimate 5.10 is undergoing an independent 21 CFR Part 11 / Annex 11 / GAMP assessment — see the validation page for current status and the update policy.
- How does V5 remove spreadsheet risk?
- Assay and moisture corrections, yields, reconciliations and limit checks are computed by the system under version control, with inputs and formula version recorded on the batch record.
- What about audit trail review workload?
- Review is risk-based: the system queues exceptions — changed results, overridden limits, late or delegated signatures — so review is a defined, evidenced activity rather than an unachievable read-everything exercise.
- Can data stay in the UK?
- Yes. Regulated enterprise clients run single-tenant private cloud, with a UK region available, or an on-premises install where required.