Industry
GMP work instructions for pharma and biotech, audit-ready by design
Right-first-time batch preparation, line clearance and cleaning, with an audit trail inspectors can follow.
In short
In pharma, digital work instructions support GMP by enforcing the approved procedure version, capturing each completed step with user and timestamp, and requiring evidence photos at critical points. This reduces deviations during batch preparation, line clearance and cleaning.
Typical processes
- Batch preparation and weighing
- Line clearance
- Cleaning and changeover
- Equipment qualification
- Operator training records
- Scope
- 1–2 lines, 1 process
- Duration
- 6–8 weeks
- KPIs
- Deviations
- Prerequisite
- baseline across several shifts
Frequently asked questions
No platform is GMP-validated without context: validation is done per customer for the intended use, within your own quality system. We support you with documentation on the platform and with setting up roles, approvals and the audit trail.
No. Actarion guides execution on the floor. Results and records can go to your MES or EBR through the API or CSV export, so the batch record remains the source.
Changes follow your change-control process. Only the approved version is published to devices.
See your own process as a digital work instruction.
In 30 minutes we look at your process, your numbers and the fastest route to a measurable pilot. No sales pitch, just concrete advice.