Manufacturing processes have long been paper-based with log entries, initialing, signoffs and other transactions to manually record. While automation systems have captured some of this manual recordkeeping, they have not been able to capture everything.In batch manufacturing processes that produce thousands of batches each year, maintaining paper records for each batch is a time-consuming, error-prone, and costly process. Ensuring the accuracy of thousands of records is difficult to say the least—and not very easily searchable. For cell therapeutics manufacturing operations with individualized batches, the difficulty is even greater.
I caught up with Emerson’s Bob Schiros who explained that many batch manufacturers are turning to manufacturing execution systems (MES) to provide paperless procedures and recordkeeping. With digital documentation, accuracy and accessibility are improved and it is easier to validate batch history for compliance audits.
Manufacturing execution systems, such as Syncade MES, help move manual, paper-based methods to online, digital methods including:
- Electronic Batch Records that reduce errors and help manufacturers ensure the identity, potency, purity, quality, and safety of right-first-time products.
- Material management within the electronic batch records that provide real-time verification during production and easy access to material data for review and compliance requirements.
- Comprehensive reports that offer aggregated information from multiple process historians, suitable for batch release, manufacturing intelligence, equipment optimization, quality documentation, and regulatory compliance.
The Electronic Batch Records module aggregates data across disparate sources of stored information and provides one consolidated record. Data from enterprise resource planning (ERP), clinical trial management systems (CTMS), laboratory information management systems (LIMS), corrective and preventive action (CAPA), computerized maintenance management systems (CMMS), distributed control systems (DCS), among others, is collected into a single comprehensive record of manufacturing – transforming distributed data into an integrated batch record.
The Weigh and Dispense module helps production personnel assign, track, weigh, dispense, and report all materials-related information. Automating the information gathering process eliminates the need for separate and disconnected dispense operations and associated paper logbooks.
These electronic batch records combined with integrated Document Management helps to streamline approvals, prepare for audits, and reduce the overall paper footprint of the batch manufacturing processes for manufacturers.
Bob noted that Emerson experts across the lifecycle of cell therapy and other pharmaceutical and biotech manufacturing process can help with a digital transformation from paper-based to fully digital recordkeeping.