Strategic Information Group – Validation Software and Services

FDA Software Validation

The FDA and other similar global regulatory agencies require that all production and quality systems software should have documented requirements that fully define its intended use and show that when tested the systems are performing as intended.

Strategic helps you manage the mandatory validation process using our proprietary Software Validation Master Plan (SVMP), tailored specifically for your company. Our validation rationale and pre-written protocols can save your company time and money. We have performed systems validations hundreds of times so you can be confident in our skills and abilities.

Our protocols - including Installation Qualification (IQ) Protocols, Operational Qualification (OQ) Protocols and Performance Qualification (PQ) Protocols - provide documented verification that all key aspects of the software were installed, and that they operate and perform in accordance to design requirements. We then generate a Traceability Matrix, Risk Analysis and Final Report that includes QAD validation conclusions and recommendations.

Our 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.

Validation Services

• 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

The Value of Strategic Information Group’s Validation Software for QAD Enterprise Applications

• Pre-written protocols to cover all areas of QAD Enterprise Applications requiring validation
• Version specific protocols available for eB2 through the current release
• Eliminates the need to manually create validation protocols for your system
• Reduces risk in times of an FDA audit
• Provides a written record of your companies validation procedures and process

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