Services
ERP Validation Rationale
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) development
- 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.
Markets Served
Strategic serves the Life Sciences industry, including:
- 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.
By choosing an ERP that is designed to simplify validation and Strategic Information Group with considerable experience in this area, Vita-Tech was able to implement QAD including validation in just 90 days.
Without the technical, functional, FDA, and SOx expertise of the Strategic consulting group, We would not have been able to meet our aggressive schedule and overcome the inherent challenges in implementing and integrating QAD Enterprise Applications at sites across Europe, North America and Japan. The project exceeded our expectations.
