“When we want to review the SOPs, it’s important for us to have a very precise procedure and to be sure that we have a controlled environment to change an SOP,” said Denis Beauchemin, head of IT for Pharmascience. “You want to be sure that you have well-defined security and an audit trail.”
More than simply replacing paper with digital documents, Pharmascience needed a reliable Enterprise Content Management solution augmented with authorization and workflow capabilities that could be integrated into existing systems.
Integrated digital document management
In Canada alone, more than 45 million prescriptions per year are filled with Pharmascience products. In 2017, the pharmaceutical company established its own prescription for an effective document management solution: a central, compliant repository with integrated workflow across all users and locations.
Pharmascience deployed OpenText™ Content Suite and OpenText™ Regulated Documents in November 2017, working with OpenText™ Professional Services to implement the integrated solution and OpenText™ Managed Services to run the environment.
“We checked different software vendors,” said Beauchemin, “but the decision was easy to make after the evaluation of the cost benefits and also because OpenText provides smooth integration with SAP® and our other systems.”
Production employees now view digital SOPs in realtime. “Employees access recipes and procedures while they are doing the job. By bringing the SOPs on the floor directly we are able to see a big difference,” Beauchemin noted.
The right information is now accessed at the right time, avoiding duplication and ensuring compliance through standardized documentation of changes—crucial for adhering to CGMP (current good manufacturing practices) regulations.
Gathering all documentation into one place with Content Suite became critical to Pharmascience operations. It serves as the foundation and connects other enterprise applications, including LMS, QMS (learning and quality management systems) and OpenText™ Extended ECM for SAP® Solutions, aligning the company’s SAP environment with manufacturing best practices.
Pharmascience relies on Regulated Documents to manage SOPs throughout a controlled lifecycle. Authorized access ensures security and electronic signatures simplify approvals. Workflow capabilities enable classification and automated progression from revision through expiration and archiving all drive GxP compliance.
In all, OpenText content management reduces issues while speeding time to market. “Our OpenText document management system is now key in maintaining the quality of our products,” Beauchemin said.
Fewer deviations, faster delivery
Following the OpenText implementation, Pharmascience experienced fewer changes and faster time-to-market. “By following more precisely the recipes and the SOPs, we have less deviation,” Beauchemin stated. He noted that easy information access, improved collaboration and version control eliminated document duplication and delays. “It is a mix of different gains, but the result is a very big impact for Pharmascience.