Clarkston recently partnered with a client that is a biopharmaceutical company developing, manufacturing, and marketing regenerative biologics utilizing human placental allografts for multiple sectors of healthcare. The client has over 45 placental tissue issued and allowed patents on their products and technologies, with over 90 pending applications at this time.
The organization was originally questioning their “audit ready” status of their business systems. They determined an assessment of their validation documentation for the business systems and associated infrastructure housed at their third-party data center provider was the appropriate action to take.
Clarkston Consulting collaborated with the client to perform an assessment of their validation documentation and retrospective validation qualifications of the business systems and associated infrastructure housed at their third-party data center provider. The client wanted to create an “audit ready” packet of validation documentation to ensure compliance with industry standards. The benefits of this approach provided the client with traceability back to vendor settings, ability to troubleshoot, ability to regression test, and ability to upgrade.
The primary objectives for the application managed services provider team included performing an assessment and retrospective installation qualification for the business systems and associated infrastructure house at their third party data center provider, as well as perform an original risk assessment. The resolution for the team involved supporting documentation for systems that were reviewed and where gaps were identified. The team had the goal to get the Infrastructure Qualification (IQ) documentation to an ‘audit ready’ state. The team completed and loaded in the company’s QMS system for a number of items for the ERP System, shipping and receiving, quality and manufacturing including installation qualification, successful change management, release statement, system interactions and back-up, validation report, work instructions and training records, validation protocol, and training records.