Qualify My Laboratory
What You Are Dealing With
Your laboratory operations touch every product your company makes and every result that gets reported to a regulator. When laboratory equipment is not properly qualified, methods are not validated, or systems are not compliant with GMP and data integrity requirements, the downstream risk extends well beyond the lab. An audit finding in the laboratory can hold up a batch release, delay a submission, or trigger broader regulatory scrutiny. You need someone who understands both the technical requirements and the compliance standard your lab has to meet.
How We Approach It
We assess your laboratory operations against GMP, GLP, and applicable regulatory requirements, identify the gaps that carry the most risk, and execute the qualification, validation, and compliance work needed to close them. That covers equipment qualification, instrument validation, computer system validation, inspection readiness, and audit support across all laboratory functions.
What We Have Done
An API manufacturer engaged MEDVACON to perform laboratory equipment qualification and system suitability testing across a full range of analytical instruments including HPLCs, spectrophotometers, particle sizers, and pH meters. MEDVACON produced all qualification and system suitability documentation onsite, and the client retained MEDVACON for ongoing support following the engagement.
A pharmaceutical manufacturer engaged MEDVACON to conduct computer system validation and equipment qualification for the implementation of Waters Empower 3 Chromatography Software across their laboratory. MEDVACON developed the full validation plan, all protocols, and executed all validation documentation. The project resulted in successful validation and MEDVACON was retained for additional work at the site.