Critical Manufacturing and Dataworks partner to take regulated industries into a new era of system validation

Critical Manufacturing, a pioneer in future-ready, multi-site manufacturing execution systems (MES), has announced its strategic partnership with Dataworks, a leading provider of innovative software solutions and validation services to the Life Sciences sector. The agreement will help ensure easier compliance and reduce the time and cost associated with validation within regulated industries, such as medical devices and life sciences.

Francisco Almada Lobo, Chief Executive Officer and co-founder at Critical Manufacturing, says, “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. One of our aims will be to streamline and automate elements of the validation process, which will significantly reduce the challenges in terms of effort, time and the risk of errors. 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. The approach 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 health care cost outcomes and add benefits to users, vendors and patients.

Almada Lobo continues, “The faster companies can implement such systems, the quicker 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 customers are getting a solution that will deliver benefits today and into the future.”

Computer Software Assurance (CSA), as defined by regulatory authorities such as the FDA in the USA and EMA in Europe, requires end-to-end traceability between requirements and end-testing along with thorough execution 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 timeline of the validation phase from months to just a few days.

Liam Curham, CEO at Dataworks, says, “We are delighted to be partnering with Critical Manufacturing. Its solutions are designed and proven to take the life sciences industry to a new and more dynamic era. Dataworks core business is providing solutions that digitally transform how our clients work within the Life Science sector. 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. We also provide validation services as part of our core business, and this fits perfectly with Critical Manufacturing’s MES, which is focussed on processes and requires validation once installation starts. 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. It fits with the direction in which regulatory bodies are pushing the industry to move, and a direction that makes complete sense in terms of the benefits it offers to all stakeholders.”