Critical Manufacturing, Dataworks Partner for a New Era of System Validation


Critical Manufacturinga pioneer in future-ready multi-site manufacturing execution systems (MES), announced its strategic partnership with Data Works, a leading provider of innovative software solutions and validation services for the life sciences industry. The agreement will help facilitate compliance and reduce the time and cost associated with validation in regulated industries, such as medical devices and life sciences.

Francisco Almada Lobo, CEO and Co-Founder of Critical Manufacturing, said, “Dataworks is focused on delivering transformational software solutions and validation services to the life sciences industry, and this partnership enables us to provide these services to our customers. . One of our goals will be to streamline and automate elements of the validation process, which will significantly reduce the challenges in terms of effort, time and risk of errors. Many medical device and life science companies still perform manual validation processes, using paper scripts, screenshots, and PDFs. However, regulatory agencies, 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 help businesses realize the enormous benefits this has to offer. »

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

Almada Lobo continues: “The sooner companies can implement such systems, the sooner they can add value to production processes. Our partnership with Dataworks will help facilitate this and, through the combined knowledge and expertise of our companies, will ensure that customers get a solution that will deliver benefits now and in the future.

Computer Software Assurance (CSA), as defined by regulatory authorities such as the FDA in the United States and the EMA in Europe, requires end-to-end traceability from requirements to final testing, as well as execution. depth of the tests themselves. Critical Manufacturing CSV ensures a smooth and automated validation process, which can be run automatically at any time and reduce the time for the validation phase from months to just days.

Liam Curham, CEO of Dataworks, said, “We are delighted to partner with Critical Manufacturing. Its solutions are designed and proven to usher the life sciences industry into a new, more dynamic era. Dataworks’ core business is providing solutions that digitally transform the way our customers work in the life sciences industry. 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 clients, their team and their patients. We also provide validation services as part of our core business, which fits perfectly with Critical Manufacturing’s MES, which is process driven and requires validation once installation has begun. Both of our companies use Azure DevOps for development, which means there are many opportunities for deep technical collaboration to improve automation of the approval process. This is an exciting time for both of our businesses and the agreement will bring tremendous benefits to our customers. This is the direction in which regulators are pushing the industry to move, and a direction that makes sense in terms of the benefits it delivers to all stakeholders.


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