The main market opportunities involve providing training and solutions for regulatory compliance and V&V best practices in regulated industries. This includes developing Master Validation Plans, ...

The life science industry faces opportunities in enhancing cGMP compliance by developing robust, risk-based Validation and Verification strategies. Training on creating effective Master Validation ...

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance ...

BOSTON--(BUSINESS WIRE)--Sware, provider of the most complete software validation solution for innovative life sciences companies, today announced that it raised $6 million in Series B funding, ...

On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on ...

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 ...

Inadequate process validation related to medical devices was cited more than 600 times by the US Food and Drug Administration (FDA) in 2013. In efforts to meet the agency’s standards, device ...

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.

Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support ...