Pharmaceutical and life sciences
Signed audit trail records for life sciences.
Security built for regulated labs and plants
Research and regulated production depend on records people can trust. A protected copy of available system activity supports security investigation while the laboratory or production system retains its own recordkeeping role.
Rules
| Rule | What the inspector tests | Supporting records | Stays with the company |
|---|---|---|---|
| 21 CFR 11.10(e) | An independent, time-stamped audit trail. | A signed, independent copy. → | The system’s own audit trail. |
| Annex 11 §9 | Audit trails regularly reviewed. | Scheduled reports, and alerts when logging stops. → | QA’s review. |
| FDA data integrity Q&A | One account, one person. | Flags shared accounts. → | Unique accounts in the GxP system. |
| 21 CFR 11.50, 11.70 | Electronic signatures. | None. → | Signatures. |
| 21 CFR 211.68(b) | Controls on computerized systems. | Role-based access and a console audit log. → | Validating Security support for its intended use. |
21 CFR Part 11
A retained copy gives security reviewers access to the relevant history without relying only on the source application’s console. Integrity checks support that review; the source system’s required audit trail and validation remain part of the quality program.
Logging gaps
Source-health alerts in a SIEM bring interruptions in expected records to the team’s attention. Preserve the gap and recovery history so reviewers can assess what evidence is available.
Data integrity
Attributable records need a reliable connection between an action and its user. Concurrent sessions or unusual account use can prompt review, but the investigation should establish the context rather than assume a shared login from one signal.
Trade secrets
DLP content and file-recognition policies can protect research information on covered transfers, including approved AI tools. Encryption and documented exceptions can support legitimate collaboration where those options fit the channel.
By rule
Annex 11 §9
Audit trails regularly reviewed. Collection-health monitoring in a SIEM shows when a source stops reporting and helps the team investigate the gap.
Questions
What about AI tools?
Apply the research data policy to covered prompts and uploads. The record should identify the relevant user, destination and policy decision without collecting more content than the review needs.
Does it change a validated system?
Analysis can use a copy of available logs. The organization’s quality and system owners determine whether the proposed collection or integration change requires assessment or validation.
What stays with the company?
The company retains its source-system audit trails, electronic signatures, quality review and validation responsibilities. The monitoring deployment has a defined security purpose within that environment.
Guide
What does 21 CFR 11.10(e) require?
Secure, computer-generated, time-stamped audit trails that record changes without obscuring earlier entries.
What is ALCOA+ data integrity?
Data that is attributable, legible, contemporaneous, original and accurate, plus complete, consistent, enduring and available.
What does EU GMP Annex 11 say about audit trails?
Audit trails should be available, readable and regularly reviewed.
How ARRTECH takes care of life sciences security
Connects security activity into a signed record, giving incident decisions and board reporting evidence that can be independently verified.
Protects intellectual property and customer trust, with content-aware controls that let organizations adopt AI on their own terms.
Expands response capacity through automation, with defined human authority and a record of who approved what.
Finds changes in behavior that predefined rules miss, connecting the signs of an attack so teams can understand what warrants action.
Investigates alerts, tests explanations and prepares the evidence, giving analysts more capacity while people retain authority over the response.
