MES and LIMS sit close to the product. One records how each batch was made. The other records whether it passed testing. We validate both, in pharma production and GLP labs.
Validation of manufacturing execution systems such as Werum PAS-X and DeltaV.
Validation of laboratory systems such as LABVANTAGE in GLP labs.
Data moving between MES, LIMS, and ERP has to arrive intact. We validate those interfaces and manage each system from implementation to retirement.
We check audit trails, access controls, and records against Part 11 and Annex 11.
A biotech is moving from clinical to commercial manufacturing. It needs a validation lead who has worked in biologics GMP production before.
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 validation project with milestones tied to your implementation or upgrade.
An MES / LIMS validation professional who joins your team for an implementation, 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.