When an ERP system controls batch records, inventory status, or quality decisions, it is a GxP system. We validate SAP, Oracle, and similar platforms, including SAP S/4HANA, SAP ECC, and SAP QM.
We plan, execute, and report validation for implementations, upgrades, and revalidation.
Test protocols and evidence for the parts of the ERP that affect product quality.
During an upgrade, IT wants to move fast and quality wants every change documented. We keep change control moving between them.
Configuration and validation support for SAP QM and similar modules.
Keeping the validation documents current so you are ready when an investigator asks for them.
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 biotech is moving from clinical to commercial manufacturing. It needs a validation lead who has worked in biologics GMP production before.
An ERP validation project run on your implementation or upgrade schedule.
An ERP validation lead or analyst who joins your team for the length of an upgrade or revalidation.
Hiring for an ERP validation role? Read The ERP Validation Hiring Manager’s Guide to Staff Augmentation.
Share your situation and the systems involved, and we will outline how we would approach it.