M-GXP Consulting
Expert Validation, Quality, and Compliance for Life Sciences
M-GXP Consulting
About M-GXP Consulting
What we do
M‑GXP Consulting provides high‑impact expertise in Validation, Quality, and Compliance for regulated life‑science organizations. With more than two decades of leadership experience across biotech, pharma, CDMOs, and regulated SaaS, M‑GXP Consulting delivers practical, compliant, and scalable solutions that accelerate operational readiness and withstand regulatory scrutiny.
What we deliver
Commissioning, Qualification & Validation (CQV)
- Specification development, revision, management.
- Master plan and schedule development.
- Risk assessment development and review.
- Factory and site acceptance testing.
- Integrated C&Q for new and renovated facilities, utilities, manufacturing equipment, and laboratory systems.
Computer System Validation (CSV) & Computer Software Assurance (CSA)
- On-Prem and SaaS GxP applications.
- Vendor assessments/audits.
- Infrastructure mapping, documentation, and testing.
- CSA risk assessment delivery.
- Targeted CSV and CSA testing to supplement vendor provided test cases.
- Data integrity planning, assessments, and remediation.
Additional Validation
- Simulated and real-world shipping validation, including package integrity testing.
- Cleaning assessments, calculations, for cleaning verification and validation protocols.
- Risk-based swab/sample site selection and identification.
- Stage 1, 2, and 3 Process Validation / Process Performance Qualification documentation
Quality Systems & Compliance
- SOP, policy, and work instruction development and enhancement.
- On-site and remote audits of vendors, suppliers, as well as internal audits.
- Regulatory audit response support.
- Management and leadership to support deviation closure, CAPA creation and management, and change control programs.
- QMR development and delivery.
Documentation Excellence
- CQV protocol development, execution, and summary.
- Periodic review of validated state.
- User access and audit trail review.
- Document archival.
- Electronic signature implementations (DocuSign, Adobe Sign).
Contact Us
Questions or Comments?
We know that our clients have unique needs. Send us a message, and we will get back to you soon.
