Compliance, traceability, and CoAs

Standards we support (through controls + evidence)

iMonitor is designed to support regulated manufacturing environments. Depending on your industry, the same underlying capabilities help with ISO-aligned quality systems (e.g., ISO 9001), food safety programs (e.g., FSMA), and GMP-style execution.

• Enforced steps, checks, and sign-offs (SOPs as execution workflows)
• Role-based access and approvals
• Time-stamped, attributable records (who/what/when)
• Exception handling: holds, deviations, rework, and escalation paths
• Searchable historical records for audits and investigations

Traceability and genealogy

Traceability is the ability to answer “what happened, and what did it affect?” Genealogy is the structure that links raw materials → WIP → finished goods → shipment.

• Lot/batch relationships across receiving, stores, production, packing, and dispatch
• Consumption, substitutions, and reconciliation captured at the step where they occur
• Fast recall scoping: identify impacted lots, customers, and shipments
• Evidence attached to the record (measurements, photos, signatures)

Certificate of Analysis (CoA) generation

If you generate CoAs, the bottleneck is usually compiling results and ensuring they match the released batch. iMonitor can generate CoAs from captured quality results and batch context, using your templates and approval steps.

• Pull test results and batch metadata into a controlled CoA template
• Link the generated CoA to the exact lot/batch record it represents
• Support review/approval before release or dispatch
• Reduce manual copy/paste and transcription error risk

21 CFR Part 11 (electronic records and signatures)

iMonitor includes common supporting controls used in Part 11 contexts (e.g., audit trails, access control, attributable actions). Part 11 compliance depends on intended use, configuration, and your validation and procedural controls.

• Audit trails: time-stamped records of creation/change with user attribution
• Electronic approvals/sign-offs tied to roles and workflow steps
• Versioning/controlled changes for workflows and specifications
• Exportable records to support validation and inspection readiness

How to evaluate fit for your standard

The fastest way to validate “does this support our compliance requirements?” is to walk one workflow end-to-end with your QA/operations team: inputs, checks, exceptions, approvals, and the final record.