Validating software process


10-Dec-2017 10:50

It can also be defined as to demonstrate that the product fulfills its intended use when deployed on appropriate environment.

It answers to the question, Are we building the right product?

For majority of the regulated life science companies, the guidance created a systemic shift in the expectations of their validation programs.

Moving from current 3 batch process to 3 stage process requires significant changes with traditional validation process and approach.

Your software may be compliant, but you may not be.

This article provides answers the top five most common software validation and documentation questions asked by others in FDA regulated industries and demonstrates best practices for meeting the guidelines. The FDA mandates that software used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use shall be validated.

Verification is concerned with whether the system is well-engineered and error-free.

These systems allow you to configure the software to meet your business needs.In year 2011, FDA published its new guidance for industry on Process Validation: General Principles and Practices.Even though the new guidance aligns process-validation activities with the product life-cycle concept and with existing harmonized guidelines such as the ICH Q8, ICH Q9 and ICH Q10.An additional challenge is that traditional process validation is a paper-based very inefficient and time consuming process.

Paper-based process validation lifecycle creates a significant amount of challenges while managing the process validation lifecycle as per new process validation guidance.

Have passed 11 years playing with automation in mammoth projects like O2 (UK), Sprint (US), TD Bank (CA), Canadian Tire (CA), NHS (UK) & ASOS(UK).



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