When simplifying and leaning the documentation and workflow first, the question “Are you ready for EBR/MES deployment?” can be answered and financially justified.
A workflow, such as creation of an electronic master production and control record (MPCR), is an intended use of a computer system to be checked through validation (see §§ 211.63, 211.68(b), and 211.110(a)).
If you validate the computer system, but you do not validate it for its intended use, you cannot know if your workflow runs correctly. For example, qualifying the Manufacturing Execution System (MES) platform, a computer system, ensures that it meets specifications; however, it does not demonstrate that a given MPCR generated by the MES contains the correct calculations. In this example, validating the workflow ensures that the intended steps, specifications, and calculations in the MPCR are accurate.
This is similar to reviewing a paper MPCR and ensuring all supporting procedures are in place before the MPCR is implemented in production (see §§ 211.100, 211.186, and 212.50(b), and the guidance for industry PET Drugs — Current Good Manufacturing Practice (CGMP)) 1.
We perform a comprehensive assessment of the batch record transactions, workflow, equipment capabilities, in-process testing frequencies, and data collected. We also assess interfaces with current and future systems to confirm and/or invalidate EBR/MES requirements.
This assessment can be conducted (recommended) as part of a batch record simplification and leaning initiative to identify where opportunities for improvement are needed before EBR/MES deployment. This results in reduced implementation time and costs.
( 1 Data Integrity and Compliance With CGMP Guidance for Industry, April, 2016)