Risk Management – Manufacturing Software Validation

Quality risk management is a systematic process for the assessment, control, communication, and review of risks. It is an iterative process used throughout the entire computerized system life cycle from concept to retirement. Risk Management is based on clear process understanding and potential impact on patient safety, product quality, and data integrity.
Controls are measures that are put in place to reduce risk to an acceptable level. They may be part of a computerized system function, in parallel manual procedures, or they may be downstream and intended to trap fault conditions after they have occurred, e.g., QC release testing.

InstantGMP™ MD is a medical device manufacturing software system that was designed using Business Requirements Specifications. The software is a full-scope integrated manufacturing system that streams the entire manufacturing process including inventory control, material management, specification control, and electronic batch records. Overall, the software simplifies documentation and approval procedures, increases production efficiency, and provides a centralized system for manufacturing documentation. Furthermore, quality assurance procedures were written simultaneously during InstantGMP™ MD development in order to maximize quality, reduce errors, and ensure GMP compliance.

 

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