Critical Manufacturing and Dataworks

Critical Manufacturing Partners with Dataworks To Enhance CSA Support

By MedTech Intelligence Staff
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Critical Manufacturing and Dataworks

“Many medical device and life sciences companies are still carrying out manual validation processes, using paper-based scripts, screen shots and pdfs. However, regulatory bodies, such as the FDA, are encouraging companies to take a more automated approach using computer system assurance (CSA). We are in a strong position to support companies in achieving the huge benefits this has to offer.”

Critical Manufacturing, developer of multi-site manufacturing execution systems (MES), has entered into a strategic partnership with Dataworks, a provider of software solutions and validation services for the Life Sciences sector.

“Dataworks focuses on the provision of transformational software solutions and validation services within the Life Science sector, and this partnership enables us to provide these services to our customer base,” said Francisco Almada Lobo, CEO and co-founder of Critical Manufacturing. “Many medical device and life sciences companies are still carrying out manual validation processes, using paper-based scripts, screen shots and pdfs. However, regulatory bodies, such as the FDA, are encouraging companies to take a more automated approach using computer system assurance (CSA). We are in a strong position to support companies in achieving the huge benefits this has to offer.”

CSA is a risk-based approach that allows manufacturers to concentrate testing on areas that have the greatest impact on product quality and, ultimately, patient safety. It recognizes that commercial off-the-shelf (COTS) manufacturing software, such as MES, product lifecycle management (PLM) or quality control systems have a positive impact on healthcare cost outcomes and add benefits to users, vendors and patients.

“The faster companies can implement such systems, the quicker they can add value to production processes,” said Almada Lobo. “Our partnership with Dataworks will help facilitate this and, through the combined knowledge and expertise of our companies, will ensure customers are getting a solution that will deliver benefits today and into the future.”

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