Validated integration and lifecycle management for manufacturing execution and laboratory information management systems, in pharmaceutical production environments and GLP laboratory settings.
Validation of manufacturing execution systems, including Werum PAS-X and DeltaV, and similar platforms.
Validation of laboratory information management systems, including LABVANTAGE, in GLP laboratory settings.
Validated integration between systems and lifecycle control from implementation through retirement.
Audit trail, access control, and record integrity assessed against Part 11 and Annex 11.
A biotech company transitioning from clinical to commercial manufacturing needs a validation lead and quality systems consultant experienced in biologics GMP production environments.
A biotech preparing for its first FDA pre-approval inspection needs contract compliance and CSV support, including mock inspections, documentation review, and validated systems and electronic records that meet Part 11 and Annex 11 requirements before the inspection window.
A pharmaceutical organization mid-ERP upgrade or revalidation without sufficient internal headcount to manage IQ/OQ/PQ and change control requirements.
A system validation project delivered against milestones tied to your implementation or upgrade.
An MES / LIMS validation professional embedded in your team for an implementation, upgrade, or capacity gap.
Tell us about the need, its regulatory context, and your systems environment. We will scope the engagement accordingly.