Computer System Validation and Computer Software Assurance under GAMP 5, 21 CFR Part 11, and EU Annex 11. Most of the hard questions in this work are about scope: how much testing a system really needs, and how to show an investigator why that was enough.
A system that calculates batch release data needs more scrutiny than one that schedules training. Some systems call for traditional CSV protocols. Others fit FDA's CSA guidance better. We decide based on risk.
Validation plans, requirements, IQ/OQ/PQ protocols, trace matrices, and summary reports.
We check electronic records, signatures, and audit trails against what the regulations actually require.
Closing validation gaps, including ones an investigator has already found.
Validation does not end at go-live. Change control and periodic review keep the system in a validated state afterward.
Pharma, biotech, and device companies apply these frameworks differently. Someone who has validated systems in one may need time to adjust to another, and we take that into account.
A biotech is facing its first pre-approval inspection. It needs a mock inspection, a review of its documentation, and confidence that its electronic records will hold up under Part 11 and Annex 11.
A pharma company is partway through an ERP upgrade and does not have enough people to keep up with IQ/OQ/PQ and change control.
A drug manufacturer has received a warning letter and committed to a remediation schedule. It needs a compliance lead and a CSV specialist to meet those dates.
A validation project with milestones. Examples are a new system implementation, a CSV remediation, or a move to CSA.
A CSV / CSA specialist who joins your team for a remediation, an upgrade, or a stretch when you are short on people.
Share your situation and the systems involved, and we will outline how we would approach it.