FDA Validation Toolkit Speeds The Process & Reduces Costs

GAMP 5 Guidelines describes in detail how cGMP requirements can be addressed by computerized systems and about the FDA validation strategy. As per GAMP 5, regulated companies have to document that GxP regulated systems (which keeps cGMP information) are compliant and fit well for the intended use. These guidelines define critical requirements expected of GxP computerized systems by building upon existing industry good practices in an efficient and effective manner.

FDA regulations say what a company should do, not how to do it. Without a set of templates to start with, many companies rely on their FDA validation service agency to write the necessary scripts, which adds time and cost to the validation process.

BatchMaster Software offers a set of validation templates in its FDA Validation Toolkit which satisfies FDA Guidance and ISPE GAMP® 5 best practices. These templates eliminate the need for the companies to write their own, thus accelerating the testing and validation processes, thus helping reduce validation services costs. The templates are kept in synch with FDA’s Validation best practices for documentation to reduce the risk of non conformance. For international businesses, the generated documentation is acceptable across multiple geographical boundaries, as they satisfy both FDA and ICH guidance’s (Q8, Q9 and Q10 ).