Critical Manufacturing, a subsidiary of ASM Pacific Technology, and Dataworks, a provider of innovative software solutions and validation services to the life sciences sector, today announced a strategic partnership to help ensure easier compliance and reduce the time and cost associated with validation within regulated industries. Critical Manufacturing, a company providing multi-site manufacturing execution systems (MES), aims to use the partnership to streamline and automate elements of the validation process. Streamlining the process will significantly reduce effort, time, and risk of error challenges.

“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 at Critical Manufacturing. “We are in a strong position to support companies in achieving the huge benefits this has to offer.”

Many companies within the medical device and life sciences industries still reportedly use manual validation processes like paper-based scripts, screen shots, and pdfs. However, the FDA and other regulatory bodies are now encouraging companies to instead take a more automated approach using computer system assurance (CSA).

CSA is a risk-based approach allowing manufacturers to concentrate testing on areas of greatest impact to product quality and, in turn, patient safety. Additionally, CSA recognizes that commercial off-the-shelf manufacturing software, such as MES, product lifecycle management, or quality control systems have a positive impact on healthcare cost outcomes and add value to users, venders, and patients.

“The faster companies can implement such systems, the quicker they can add value to production processes,” Almada Lobo said. “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.”

The FDA and European EMA require CSA to have end-to-end traceability between requirements and end-testing. Additionally, regulatory bodies require thorough execution of the tests themselves. Critical Manufacturing CSV can be run automatically at any time and will reduce the timeline of the validation phase from months to days.

“We are delighted to be partnering with Critical Manufacturing,” said Liam Curham, CEO at Dataworks. “We have a deep understanding of the processes in the medical device and pharmaceutical industries, and we know how to apply the right technologies. This leads to better outcomes for our customers, their team, and their patients. Both our companies use Azure DevOps for development, and this means there are many opportunities for deep technical collaboration to enhance the automation of the validation process. This is an exciting time for both our businesses and the agreement will deliver enormous benefits to our customers.”