Solutions · Pharmaceuticals & Life Sciences
Pharmaceuticals & Life Sciences
In a validated environment, who did what - and the unbroken trail proving it - is a licence-to-operate requirement, not a nice-to-have.
The pressure
What this sector is up against
Regulated pharmaceutical and life-sciences operations run validated GxP systems - LIMS, MES, QMS and manufacturing controls - where data integrity and complete, attributable audit trails are a licence-to-operate requirement under 21 CFR Part 11, WHO-GMP and Schedule M expectations. Access to these systems by staff, contract manufacturers and equipment vendors must be unique, controlled and fully logged, and inspectors expect the ALCOA+ principles to hold across every privileged action.
Frameworks that apply
How Tanflow helps
Controls mapped to this sector's reality
Every action on a validated system is tied to a unique identity - no shared logins on LIMS, MES or QMS.
Administrative access to GxP databases and application servers is vaulted, justified and recorded end to end.
Equipment and software vendors work through time-boxed, scoped, recorded sessions instead of standing accounts.
Append-only session and command logs support the data-integrity evidence inspectors expect.
Replays and access-review reports retained and exportable for regulatory and customer audits.
In practice
The LIMS upgrade and the software vendor
A LIMS vendor needs database access to apply a validated patch. With Tanflow: QA grants a time-boxed JIT window tied to the change control; the vendor connects through the browser gateway under a named identity with credentials they never see; changes to controlled data are recorded and destructive operations blocked; the session closes with the window. When the auditor asks for the data-integrity trail on that change, it is a replay away.
Business outcomes
What it means for the business
Security, compliance and efficiency in the same motion - the results leadership and auditors both care about.
- Attributable, ALCOA+ access to validated GxP systems
- Data-integrity audit trails that stand up to 21 CFR Part 11 inspection
- Lab and manufacturing equipment vendors supervised and time-boxed
- Regulatory and customer audits answered from evidence that already exists
- Shared logins on validated systems eliminated by design
Live in 2-4 weeks
Deployed on your infrastructure - on-premises, private cloud or hybrid - and backed by a local OEM team you can reach directly.
Get a Demo →Talk to us about Pharmaceuticals & Life Sciences
We'll walk through your environment, your regulator's expectations and a deployment plan measured in weeks.