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Orientation in eight questions

Data Integrity Check for GxP Systems and Laboratory Instruments

In a few minutes, assess how robustly roles, audit trails, raw data, backups and responsibilities are organised. The evaluation identifies initial priorities without collecting personal data.

A transparent quick check, not an audit

The check draws on ALCOA+ and common requirements in EU GMP Annex 11, FDA and PIC/S guidance. Scoring is explicit: Yes = 3, Partly = 2, Unknown = 1, No = 0. The result provides orientation and is neither an audit nor legal advice.

Evidence Review · 8 questions
Step 1 of 2
Step 1: systems and data
01 · AttributionDoes every person use an individual account with role-based access, without shared logins?

Requirement aligned with EU GMP Annex 11, section 12: Security.

02 · Audit trailAre relevant audit trails enabled, protected and reviewed in a documented, risk-based manner?

Requirement aligned with EU GMP Annex 11, section 9: Audit Trails.

03 · Data lifecycleAre raw data, metadata, evaluations and changes fully defined and available throughout retention?

Requirement aligned with PIC/S PI 041-1, sections 5.1 to 5.2 and 7.4 to 7.7: data lifecycle and ALCOA+.

04 · RetentionAre backups created regularly, with restoration and archive retrieval demonstrably tested?

Requirement aligned with EU GMP Annex 11, sections 7.2 and 17: backup and archiving.

Step 2: processes and governance
05 · Data transferAre interfaces and manual transfers identified and protected by documented accuracy checks?

Requirement aligned with PIC/S PI 041-1, section 9.4: data transfer and migration.

06 · GovernanceAre data integrity responsibilities, SOPs and training current, understandable and effective?

Requirement aligned with PIC/S PI 041-1, sections 5.2 and 6.2 to 6.6: data governance, roles and training.

07 · Laboratory instrumentsDo system and supplier documents demonstrate adequate audit trail, user management, data export and long-term availability?

Requirement aligned with FDA 21 CFR Part 11, § 11.10: controls for closed systems and EU GMP Annex 11, sections 3 to 4: suppliers and validation.

08 · EffectivenessDo deviations, CAPA, changes and trends feed into documented periodic reviews?

Requirement aligned with EU GMP Annex 11, section 11: Periodic evaluation.

Regulatory context and target groups

For operators

Pharma, biotech and laboratory organisations gain an initial view of technical, procedural and organisational gaps.

For instrument suppliers

We support DI-ready system design, audit trail and user concepts, technical documentation, interfaces, supplier audits and qualification documentation.

Develop data integrity with robust evidence

Discuss the full questionnaire, your GAP Assessment or requirements for a new laboratory instrument with our advisory team.

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