As Life Sciences companies expand globally, opening new facilities or adding new suppliers, they face three main document and training management risks: compliance and regulatory issues, lost knowledge and change management.
Regulatory Scrutiny: Global regulatory agencies, including US FDA, have made procedural control a top enforcement issue. In fact, the most cited US FDA observation of pharmaceutical companies in 2015 was “Procedures not in writing, fully followed” (21 CFR 211.22(d)).
Lost Knowledge: When most of the operational knowledge resides with a few people, organizations are at risk to lose best practices. It could take many months for a new team to define and map the governance process when crucial individuals move to new job roles, draining organizational resources and impacting operational efficiency.
Change Management: Companies are expanding rapidly, either through organic business growth or acquisition. As business areas evolve, new procedures on managing SOPs, employee qualifications, and training are being implemented.
Document management systems (DMS) eliminate many of the “paper shuffling” tasks, reducing regulatory risk and allowing document owners to devote more time developing SOPs. Automating routing of documents and version control, and easily providing a full document history, streamlines the approval and filing process.
Integrating DMS and LMS applications facilitates timely SOP management and training. Well-integrated, modern solutions improve the process, making it more efficient and effective. When developing a governance strategy that spans both systems, organizations need to consider how it will impact existing processes and ensure the DMS to LMS integration supports the alignment approach.
To calculate the cost savings of automating the SOP training item creation in the LMS, we developed a case study, in which a Life Sciences company wanted to measure cost savings based on the amount of time employees were spending on SOP training management activities. The company did not have any DMS to LMS integration feed or application in place. The company used the UL CWConnector tool to integrate the Veeva Vault Quality Docs® DMS with ComplianceWire®. The company wanted to know the cost savings of automating the SOP training item creation. The team calculated the hours needed to “manually” build an SOP training item, on average, and believed that the CWConnector tool freed up the team to work on other critical training activities.
The company outlined the steps for creating and updating an SOP training item, as well as the hours needed to fulfill each step. With CWConnector, many steps, including notifying users of the new training item, were eliminated. In addition, the automated DMS to LMS flow reduces the risks associated with improper data entry when SOP training items are manually entered in the LMS. This automation also gives administrators more time to focus on other critical activities. Given the investment made in the applications, such an integration method can pay for the investment and generate a return on investment in six months.
UL, with Veeva’s support, has developed an integration tool that embeds governance best practices into the DMS to LMS integration. The tool, CWConnector, leverages Vault’s Public APIs to enable the integration between the Veeva Vault QualityDocs DMS and UL’s ComplianceWire LMS.
To learn more, and view a demo, contact Pat Thunell
For the full article from our Pharmaceutical Communiqué, click here.