We deliver Computer System Validation and Computer Software Assurance across GAMP 5, 21 CFR Part 11, and EU Annex 11, including electronic records and audit trail integrity, for pharmaceutical, biotech, and medical device organizations.
We apply both legacy CSV protocols and the FDA's 2022 CSA guidance based on system risk classification, not one approach across all systems.
Validation plans, requirements, IQ/OQ/PQ, traceability, and summary reporting for GxP systems.
Electronic records, electronic signatures, and audit trail integrity assessed against the regulations.
Closing validation gaps, including gaps raised in inspection findings.
Change control and periodic review that keep systems compliant after go-live.
Pharmaceutical, biotech, and medical device environments differ significantly in how they operationalize these frameworks, and experience in one does not automatically transfer to another.
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 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 validation project delivered against milestones, such as a new system implementation, a CSV remediation program, or a CSA transition.
A CSV / CSA specialist embedded in your team for a remediation, upgrade, or capacity gap.
Tell us about the need, its regulatory context, and your systems environment. We will scope the engagement accordingly.