I was digging around for the story behind the story of a biotech manufacturer, Repligen’s improved compliance through document management project. Emerson’s Lynn Richard was the solution architect who worked with the Repligen team. Given the production volumes for this highly specialized family of proteins, the batch production process is composed of manual procedures and has extremely complex processing requirements. The batches take around two weeks to complete. It’s critical that manufacturing processes not be interrupted due to errors, especially near the end of a batch.
The article highlighted the documentation challenges:
…Standard Operating Procedures (SOPs) and Work Instructions are critical. These documents must be clear, concise and complete-and they must be continually updated to reflect changes and improvements to the manufacturing process. Batch Records are generated and issued to production in order for the operators to document each step of the process during manufacture of a batch of material.
Numerous procedural and process documents are required with highly detailed information. For example, the facility has about 200 documents, with 15 related to the pure water systems alone. Company quality procedures require review of each controlled document annually.
The manufacturing documents combine the work instructions and the documentation of each step into one Production Record document referred to as a Batch Record. Plant personnel execute the work instructions, and write the results directly into the Production Record. Each Production Record document is 100-200 pages in length. This level of detail is required to ensure consistent completion of validated processes in order to produce quality product. Documentation of each manual step provides a record of all variables that could impact the final product, such as raw materials and solutions that were used during the process.
Lynn noted that there were document types numbering in the teens and each document had separate views for document administrators, views by product for plant engineers, and views by current binder for the operations and maintenance staff.
All of these different views required separate security models for easy and appropriate access to facilitate trained personnel quickly finding and properly performing all the documented procedures and workflows. Also, the existing review and approval process was extremely detailed and had a complicated and different workflow for each of the document types. Even the batch print rules were complex and required customization.
Lynn worked with the Repligen team to develop the security models and three or four of each type of configuration. He then worked with the team to take them through the configurations to learn all the ins and outs of the platform, Syncade Document Control and Archiving (DCA), used to manage the documents and associated workflow. From there, the project team executed the rest of the required configuration.
As with many industries, anything that can be done to shave time off the overall production time cycle increases the overall operational efficiency. For biotech manufacturers, fully completed and accurate batch records are a required part of this production process before the finished product can ship. For this project, issuance time per batch record was reduced from 4 to 2 hours and one week’s production records issuance time was reduced from 16 to 6 hours.
Because Lynn’s consulting and training were a key part of this project, the plant’s in-house staff developed the skills required for maintenance, upkeep, and expansion of their document management process.