Validation lifecycle ownership and quality module support for SAP, Oracle, and related enterprise platforms, including SAP S/4HANA, SAP ECC, and SAP QM, for production-critical systems in GxP-regulated manufacturing.
Planning, execution, and reporting for ERP implementations, upgrades, and revalidation.
Protocols and evidence for production-critical ERP functionality.
Coordinating change control between quality, IT, and operations during upgrades and configuration changes.
Support for SAP QM and related quality modules.
Keeping ERP validation documentation and validated state ready for inspection.
A pharmaceutical organization mid-ERP upgrade or revalidation without sufficient internal headcount to manage IQ/OQ/PQ and change control requirements.
A pharmaceutical organization under FDA warning letter needs a compliance lead, a quality systems consultant, and a CSV specialist to support remediation commitments within the agency's required timeline.
A biotech company transitioning from clinical to commercial manufacturing needs a validation lead and quality systems consultant experienced in biologics GMP production environments.
An ERP validation project delivered against your implementation or upgrade schedule.
An ERP validation lead or analyst embedded in 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.
Tell us about the need, its regulatory context, and your systems environment. We will scope the engagement accordingly.