Quality Systems and Validation form the core of the practice. ERP validation, MES/LIMS, and remediation work sit underneath that core as specialized areas. Each requires regulatory depth and the judgment that comes from working inside GxP-regulated organizations, whether pharmaceutical, biotech, medical device, or CDMO.
QMS design, maintenance, and improvement in GxP-regulated life sciences organizations. CAPA management, deviation handling, document control, and quality event workflows that function correctly under FDA inspection, not only in routine operations. Professionals with direct experience maintaining compliant QMS function during audits, warning letter responses, or consent decree oversight carry different value than those who have not.
Computer System Validation and Computer Software Assurance expertise across GAMP 5, 21 CFR Part 11, and EU Annex 11, including electronic records and audit trail integrity. Practitioners who can apply both legacy CSV protocols and the FDA's 2022 CSA guidance based on system risk classification, not just one approach across all systems. Pharmaceutical, biotech, and medical device environments differ significantly in how they operationalize these frameworks, and experience in one does not automatically transfer to another.
Professionals who manage compliant change workflows, remediation initiatives, and deviation resolution under FDA regulatory scrutiny. Frequently engaged during FDA Form 483 observation responses, warning letter remediation, pre-inspection cleanup efforts, and consent decree support at life sciences organizations.
Validation lifecycle ownership and quality module support for SAP, Oracle, and related enterprise platforms, including SAP S/4HANA, SAP ECC, and SAP QM. These professionals own IQ/OQ/PQ documentation, change control coordination, and inspection readiness for production-critical systems, carrying responsibility for maintaining compliant validation state through upgrades and configuration changes.
Validated integration and lifecycle management for manufacturing execution and laboratory information management systems. Experience with Werum PAS-X, DeltaV, LABVANTAGE, and similar platforms in pharmaceutical production environments and GLP laboratory settings.
Program-level oversight for validation remediation programs, system implementations, and upgrade efforts. These leaders understand validation lifecycle dependencies, cross-functional coordination between QA and IT, and the regulatory consequences of schedule slippage when an FDA inspection date or remediation commitment is fixed. Technical project management without GxP context is not a substitute.
Tell us about the role, its regulatory context, and your validated systems environment. We will scope the engagement accordingly.