26 September 2018 – A leading provider of assay solutions to pharma, biotech, and clinical research organisations has streamlined its approach to quality assurance and compliance management with the help of Epista Life Science and Formpipe Life Science.
Implemented earlier this year as part of a wider review of the Swedish analytical service provider’s compliance management, Formpipe’s X-docs EQMS platform will deliver the firm with enhanced visibility and control over the company’s quality processes and documents. Specifically, X-docs will facilitate better management of version control and updates of standard operating procedures; support easy access, audit trail insight and holistic visibility of training records; simply record, monitor and analyse deviations; easily manage corrective action activity; and optimise complaints processes.
Commenting on the implementation, Robert Pettersson, managing director (Sweden) of Epista Life Science – a specialist consultancy that works with life science businesses to continuously improve regulatory compliance, said: “This analytical services organisation has grown quickly over recent years, merging with and acquiring businesses that enhances its strength in the market. A byproduct of this is the use of multiple systems and ways of working, which can contribute to inefficiency and heightened compliance risk. By migrating all compliance processes and documentation into X-docs, a complex, disjointed and inefficient way of working is being replaced by a robust, effective and future proof method of quality assurance and compliance management.”
Providing a centralised, intelligent, simple to use and pre-validated system, X-docs is expected to slash the lead time associated with compliance-based processes by 1,000 hours per year. Time spent on document management is also anticipated to reduce by a similar amount.
Mark Stevens, managing director, Formpipe Life Science explains: “As an analytical services provider, this company carries out vital work; facilitating diagnosis, prognosis, monitoring and treatment of inflammatory diseases. X-docs will support the company to continue providing this high-level service to the life science sector, but with less manual administration and less compliance risk. We’re honoured to have been selected to support them as they work towards greater business efficiency and look forward to seeing our partnership flourish.”