Electronic production records in manufacturing use the ISA-88 model, with the master recipe, control recipe, electronic production record and batch report as the electronic equivalents of paper master and production batch records, and support review by exception, real-time disposition and cloud and distributed ledger technologies. Requirements definition identifies the data relevant to intended use from critical process parameters and quality attributes, verifies the GxP-supporting functionality of non-process systems, and defines production record data requirements, data audit trails, multi-language handling, linked external documents, security, user roles and rights, master data, specifications and metadata and time zone and time stamp handling. Data audit trails record the creation, modification and deletion of GMP records during normal operation, including status changes such as electronic approval and end-of-retention deletion, and are distinguished from technical logs; audit trail review is part of routine data review by the generating area with quality unit review where required, at the frequency the regulations set for the data or one determined by risk assessment, need not cover every system activity, may use validated exception reports, and requires reviewers with knowledge and access. ALCOA+ principles apply, master data and configuration versions are known and controlled and demonstrable for any master recipe, only regulation-required records are GxP records, and data flows across document, supply chain, execution, historian, resource planning, process control and laboratory systems are mapped with primary records defined. Data capture verifies the transformation from paper to electronic form, processing uses verified rounding rules, calculations, alerts and alarms with audit trails and security, and output uses verified methods to produce timely human-readable reports for disposition and investigation, with non-GxP reports verified for their purpose and interfaces designed, developed and verified with early partner involvement; processes and data flows are understood, periodically reviewed and assessed for data integrity gaps including through direct observation on the shop floor. Completion of production combines data by verified means into reports reviewed in sections with an overall disposition; review by exception filters verified data to the critical exceptions without altering the records, is applied to well-understood processes, requires defined system functionality, well-defined processes, operational experience, parallel comparison for novel processes, risk-based verification, retention of the underlying data in human-readable form, review at least as comprehensive as manual review, specification, verification and periodic review under configuration management, alerting of communication errors, a report generated and examined even when no exceptions occur, and exception context sufficient for retrieval, and may be phased in; real-time disposition brings quality activities close to execution with human intervention where required. Cloud hosting of process control functions requires analysis of interruption risk, data flow mapping, provider selection for data protection, edge deployment where real-time response matters, end-user responsibility for the validated state and cybersecurity including denial-of-service, and distributed ledgers are candidates for immutable audit trails.
This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.