Formpipe Life Science has been selected to provide Newcastle Emlyn-based biotech company, MicroPharm, with its new specialist electronic quality management system (EQMS) X-docs. The announcement comes just weeks after Formpipe Life Science added specialist IT regulatory compliance consultancy, Clarity Compliance, to its certified partner network.

Migrating quality assurance and compliance management tasks from a combination of paper-based processes and spreadsheets into a centralised, intuitive, and agile system, X-docs will be delivered to MicroPharm on a Software as a Service (SaaS) model. As a fully integrated developer and manufacturer of polyclonal therapeutics for the treatment of infectious disease and acute toxic events, MicroPharm will be using its X-docs subscription to manage processes including SOPs, CAPA, and training records. The module leading the implementation will be the Equipment manager module that will deliver MicroPharm control of their maintenance, calibration and servicing activities related to all production and analytical equipment. This initiative forms a critical element as MicroPharm expands and invests in a new manufacturing site. The system is pre-configured, and designed specifically for the pharmaceutical sector, validation requirements will be minimal, meaning it will benefit from quick deployment and instant access to all the features and benefits of the powerful EQMS, including its automated reporting functionality.

MediWales reports David Thompson, principle consultant at Clarity Compliance, said “MicroPharm is leading the charge in the development of polyclonal immunotherapeutic products for clinical use; carrying out invaluable work to discover treatments for often untreatable acute, life-threatening emergencies. With a market leading offering, and a growing portfolio of contract manufacture and development activity for third parties, MicroPharm recognised the need to create a best practice approach to its quality and compliance processes. Through implementing X-docs, MicroPharm will increase efficiencies in administration, documentation development, compliance and increase the assurance to internal stakeholders that documentation will be stored, accessed, and managed in accordance with compliance objectives. We reviewed a number of EQMS products, but X-docs ticked all the right boxes. It’s pre-configured, out-of-the-box, quick to deploy as it’s hosted in the cloud, and will best support the firm to take control of its quality and compliance functions.”

Welcoming MicroPharm into the Formpipe Life Science customer portfolio, alongside Recipharm and Alliance, Ben Saxton, head of Europe sales at Formpipe Life Science, said “Having access to X-docs will streamline MicroPharm’s quality and compliance functions, reducing risk and offering opportunity for the firm to assess trends and make more informed business decisions, through the EQMS’s automated reporting functionality. All of which will stand the company in strong stead as it continues its impressive journey to advance opportunities to safely and effectively treat complex medical conditions. We’re looking forward to working with the team at Clarity Compliance to offer an unrivalled product and service to MicroPharm.”