Software assessment under consideration of validation aspects: PPS and PMS systems

Area of Science:

• Pharmaceutical Manufacturing
• Computerized Systems Validation
• Regulatory Compliance

Background:

• Computer-based systems in pharmaceutical production are subject to stringent validation requirements by regulatory bodies like the FDA and EU.
• These regulations stem from critical safety aspects and business risks associated with drug manufacturing.

Purpose of the Study:

• To determine which modules within production planning and control (PPS) and production management systems (PMS) necessitate validation.
• To develop and apply a standardized questionnaire for assessing software supplier adherence to validation requirements.

Main Methods:

• A risk analysis procedure was employed to identify critical validation modules.
• A software supplier questionnaire, based on the V-model, was developed and administered to assess four prevalent pharmaceutical industry software products.

Main Results:

• The study identified that production management systems (PMS) modules are the primary focus for validation necessity.
• Application of the questionnaire revealed that software products, despite lifecycle concept development, exhibit varying degrees of compliance with validation requirements.
• A significant divergence in the interpretation of risk analysis was observed among software suppliers.

Conclusions:

• Validation efforts in pharmaceutical production should prioritize production management systems (PMS) modules based on risk assessment.
• The developed questionnaire serves as a tool to measure the validation readiness of software suppliers.
• Standardized interpretation and application of risk analysis are crucial for consistent validation outcomes in the pharmaceutical software industry.