Built for GxP.
From the ground up.
Designed around the risk-based lifecycle in GAMP 5, Second Edition. Requirements, configuration, verification and change control are part of how you build and improve processes in Seal.
Read the technical guide
Keep improving after validation.
Keep requirements and specifications (URS, FS, DS and CS) linked to the configured process and its verification. Reuse applicable supplier evidence and focus testing on your intended use and risks.
Run selected UATs in simulation alongside human testing. Keep results with the proposed revision. Your quality team owns risk acceptance and production approval; earlier work keeps its original version.
Every record.
Its full history.
See who changed what, when and which process version was used. Seal keeps the record, its audit history and electronic signatures together, including the signer’s name, time and meaning of approval.
Controls to support 21 CFR Part 11 and EU GMP Annex 11, qualified for your intended use.
“…seeking improved administrative efficiency, electronic signatures and audit trails. Seal ticked all these boxes.”
Bring AI into GxP work.
Neil investigates records within your permissions; your team controls production changes. Under Seal’s agreements, your data is not used to train the underlying AI models.
In line with the EU’s draft GMP Annex 22 on AI, Neil is not used in GMP execution. It helps set up configuration, which your team verifies and releases under change control.
Neil’s investigation
- Reads
- B-041, IPC-041
- Access
- Your permissions
Model processing
- Receives
- Selected context
- Used for training
- No
Proposed change
- Drafted by
- Neil
- Released by
- Your team
Put us through your review.
Bring your quality and IT teams. We’ll work through the supplier evidence, qualification scope and deployment arrangements together.