Quality, compliance, and validation help for drug and biologics manufacturers under 21 CFR Parts 210/211. FDA can show up at any time, so the documentation has to be ready all the time.
IQ/OQ/PQ protocols, reliable audit trails, and change control for quality systems, lab systems, and ERP.
In biologics and biosimilars, batch records, manufacturing execution, and quality events all run through validated systems.
When a biotech moves to commercial production, processes get bigger and FDA looks much more closely. The quality system usually has to grow up fast.
Getting documentation, systems, and electronic records in shape before the inspection.
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 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 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.
What do you make, what systems are involved, and what is the problem? We will tell you how we would approach it.