Every QMS workflow. One system.
No modules bolted together from acquisitions. Every quality workflow was designed to talk to every other one from the start.
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Document Control
Your numbering schema, your prefixes, your taxonomy. SOPs, CCPs, work instructions: all versioned, reviewed, and approved through configurable workflows. Review your document control details.
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Nonconformance (NC)
Capture, classify, and route nonconformances the moment they're identified. Lot hold triggered automatically. NC linked to CAPA with full audit chain preserved.
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CAPA
Corrective and preventive action workflows with root cause analysis, action assignment, effectiveness review, and closure sign-off. Fully electronic. Fully auditable.
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Supplier Corrective Actions (SCAR)
Issue SCARs, track supplier responses, and escalate to vendor qualification impact, all without leaving the platform. SCAR chain links directly to Partner Management.
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Batch Records
Electronic manufacturing records tied to lot numbers, operators, and equipment. Sign-offs at every critical step. Built-in yield tolerance checks and CCP verification. Production reports generated automatically.
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QC Release
Two-person lot release enforced at the database level, not just the UI. Test results linked to COAs. Certificates of Analysis and Conformance generated and issued from the platform.
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Lot Traceability
Full forward and backward traceability: raw material lot to finished product, finished product back to every input. Recall-ready. FSMA 204 compliant.
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Electronic Signatures
21 CFR Part 11 compliant e-signatures with PIN validation. Every signature tied to a specific user identity, a specific record, and a specific timestamp. Immutable.
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Internal Audit
Schedule, execute, and close internal audits with findings linked directly to the CAPA module. Audit history maintained for external auditor review.