It’s great that Tim Alosi, from Emerson local business partner, New England Controls, was in town this past week. He saw the recent post, Shrinking Batch Record Creation Time and Document Management Complexity. Repligen is one of New England Controls customers, and Tim had more to share on this story.
The New England Controls team originally worked with the Repligen team to define the functional requirements for the electronic document management system. This included helping prioritize these requirements based on the business objectives and improved processes around managing procedural, quality, and business documents.
As I can fully appreciate, the Repligen team was already quite consumed in the day-to-day business of specialized protein production, and managing this project on top of it, required some support from team Emerson.
Tim noted that the functional requirements definition is a critical phase in any project. These functional requirements helped to flesh out the document types, subtypes, lifecycle, naming convention, review process, and change request review and approval responsibilities. These requirements extended to various procedures, processes, forms, specifications, and external supplier documentation.
A key part of this team effort was to map out and document the workflows around document change requests, how these documents would be stored and archived, and the security structure, which needed to map into the existing IT security policies.
Some of the document types managed by the electronic document management system needed to support validated processes. Therefore, the Syncade Document Management and Archiving (DCA) solution needed to support the FDA 21 CFR Part 11 electronic signature requirements. Defining the complex printing requirements was also and important part of this planning effort.
Because the document management solution would impact people and their work processes, an extensive training program was developed to aid with the culture change. The team identified training modules required around the Syncade software, new skills not related to the software, and socialization topics to give the plant staff the full picture of the of this project, why it was important in meeting the business objectives, and how these new work processes help achieve these objectives–the what, why, and how of this effort. This training was based on the roles required for the biotech manufacturing process from start to finish.
This upfront planning helped the execution of the project and the training was a big part of growing the acceptance of this new way of managing the critical documentation around the production process.