FDA regulations direct compliance with regulatory requirements for the validation and maintenance of computer systems used to manage, control and track the manufacturing and distribution of device and pharmaceutical products.

Strategic helps you manage ERP regulation and validation using our proprietary Software Validation Master Plan (SVMP), tailored specifically for your company.

We then generate a Traceability Matrix, Risk Analysis and Final Report that includes QAD validation conclusions and recommendations.

Validation Services Include

  • QAD documentation development
  • Installation Qualification (IQ) Protocols
  • Operational Qualification (OQ) Protocols
  • Performance Qualification (PQ) Protocols
  • QAD software Validation Master Plan (SVMP)
  • 21 CFR Part 11 QAD compliance services

In conjunction with our validation services, we also offer a QAD validation toolkit with predefined protocols for the QAD ERP system.

Life Sciences Industries Served

  • Pharmaceutical companies
  • Medical device companies
  • Biotechnology companies

Our past and current clients include drug and vaccine developers, generic houses, hospital equipment manufacturers, contract sales organizations, engineering companies, fulfillment companies, clinical research, device manufacturers (including implantables) and control system manufacturers.