Can we biuld Customized sections in Batch Records in Manufacturing Process Executuion (MES)
Dear All,
We are Using Oracle EBS 12.2. We are looking to move to electronic batch record keeping. We are using Oracle Process Manufacturing, but we understand that MES can manage batch records, and before proceeding with MES implementation and integration with OPM, and before we go further, we want to ensure MES meets our business requirement.
Our batch records include sections related to GcP and other regulatory standards, such as line clearance, special checks across different factory areas, and more.
My questions are:
- Does the Batch Record functionality in MES comply with 21 CFR Part 11 regulations?
- Can we add customized sections to be integrated into the Batch Record to accommodate our specific needs
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