08.13.2019 Celia Brown

    Xerimis Reduced their On-site Audit Time by 50%, Achieves Near Instant ROI with ZenQMS

    About Xerimis

    Xerimis is a specialized company that provides clinical packaging services to pharmaceutical, biotechnology, and clinical research organizations of all sizes and for each phase of clinical development. As a global company with over 20 years in the industry, Xerimis stays true to its traditions by building and keeping long-term relationships with clients.

    Business Need

    Because Xerimis’ clients are pharmaceutical companies, they expect Xerimis to meet all of the GMP requirements specified by the FDA (21 CFR parts 210 and 211, and related p.11 / Annex 11 electronic signature requirements). Additionally, due to the dozens of on-site audits they face each year, their quality systems had to be able to keep up with the speed and scale of their business.

    A decade ago, the Quality team at Xerimis recognized that moving away from their manual, paper-based quality management system was the smart choice. An electronic solution would be beneficial to their business and far more efficient. But after reviewing the available enterprise solutions, they couldn’t justify the $1M investment and ongoing running costs, including software licenses, maintenance, implementation/qualification, hardware, and IT support. They didn’t think an eQMS would be an option for them.

    That’s why ZenQMS has been such a help.

    “We’ve been able to reduce on-site audit time by more than 50% because we are able to provide auditors access to review documents in ZenQMS.” -Jason Bissey, Director of Quality Assurance, Xerimis

    Business Impact

    After a long search, Jason Bissey, Director of Quality Assurance at Xerimis, discovered ZenQMS. He calculated that he could achieve a nearly immediate ROI due to the cloud-based nature of the solution and was able to secure necessary funds. According to him, “We were able to convince our finance department that the amount we’d save relative to our current paper-based environment meant that ZenQMS would end up paying for itself very quickly.”

    In addition to their old paper-based system being slow and tedious, the support required for the dozens of audits conducted on-site weighed heavily on Xerimis’ QA team. They would be challenged to demonstrate that their SOPs were in a state-of-control in the manual system and required formal updates every two years. With ZenQMS in place, Xerimis is able to demonstrate to auditors a review of the SOPs that don’t require the same frequent updates.

    Jason Bissey reported, “We’ve been able to reduce on-site audit time by more than 50% because we are able to provide auditors access to review documents in ZenQMS.” He also noted that feedback from auditors regarding ZenQMS has been overwhelmingly positive.

    ZenQMS continues to scale to meet the changing needs at Xerimis as their business grows, including the addition of a United Kingdom site to the system. Instead of maintaining two entirely separate sets of SOPs, ZenQMS has enabled the quality team to support both sites remotely and also establish and maintain a set of global SOPs.

    Published by Celia Brown August 13, 2019
    Celia Brown