Market opportunities include enhancing medical device quality through robust process validation training, aligning with regulatory and QMS needs, and integrating GAMPv for improved data integrity.

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This ...

Valkit MSAT digitizes GxP tech transfer with global package cloning, CDMO isolation, paperless execution, and a fixed ...

Protocols will form key part of company’s quality system. Bio-Matrix Scientific Group is entering the facility validation process arena. Working with company’s chief scientific advisor, Geoffrey ...

The Food and Drugs Authority (FDA) is training local manufacturers of pharmaceutical products on process validation for non-sterile finished pharmaceutical products to help them meet the current codes ...

Continued process verification for a cleaning validation program begins once the validation study is complete. Continued process verification (CPV) for a cleaning validation (CV) program begins once ...