Specifications that match the build
We write user requirement reviews, functional design specifications, hardware and software design specifications, alarm lists, interlock matrices and recipe structures, kept under version control alongside the code.
Risk-based qualification
Our IQ/OQ protocols and traceability matrices follow GAMP 5 (Second Edition) and the FDA’s Computer Software Assurance approach. Effort goes into the functions that affect product quality and patient safety, without repeating testing the vendor already did.
Data integrity built in
We assess every system against 21 CFR Part 11 and EU GMP Annex 11: unique logins, audit trails, electronic signatures, time sync, backup and restore. Gaps are closed in the design and tested in OQ, so audit findings don’t appear later.
Custom machinery
If you have an idea for a machine, we can take it through design, panel build, programming and documentation ourselves, so you deal with one supplier.
What you receive
- URS review & FDS
- HDS / SDS
- Part 11 / Annex 11 assessment
- IQ / OQ protocols & reports
- Traceability matrix
- SOP & training material
