Features
Everything regulated teams need.
One auditable system covering quality, manufacturing, clinical, and submissions — with cryptographic audit trails by default.
Audit Management
Plan, execute, and close out internal and supplier audits with electronic checklists, evidence capture, and signed audit reports.
Deviations & CAPAs
Risk-scored deviation intake, root-cause investigations, and corrective/preventive action workflows tied to effectiveness checks.
Controlled Documents
21 CFR Part 11 SOPs and protocols with versioning, multi-stage approval, electronic signatures, and training links.
Training Compliance
Curriculum management, role-based assignments, qualification matrices, and SOP-to-training linkage.
Clinical Trial Compliance
GCP protocol deviation tracking, IRB approvals, IP accountability, and monitoring visit reports.
Manufacturing (GMP)
Batch records, environmental monitoring, equipment qualifications, change control, and Annual Product Reviews.
Electronic Logbooks
Append-only equipment, calibration, and process logbooks with cryptographic immutability and amendments.
ISO 13485 / 9001
Clause-by-clause QMS mapping, certification lifecycle tracking, and design-control workstreams.
Risk Register
Cross-functional inherent/residual risk scoring, treatment plans, and trend tracking.
Supplier Management
Approved Supplier List, qualification audits, scorecards, and SCAR workflows.
Submissions Tracker
FDA, EMA, and notified-body submission Gantt with milestone and correspondence logs.
Inspection Readiness
Prior observation tracker, mock inspections, and live inspection war-room for agency visits.
Audit-Grade Trail
Append-only logs with before/after snapshots, IP capture, and electronic signature meanings on every change.
Enterprise Security
SSO, IP allowlisting, custom roles, audit log export, and HIPAA BAA — available on Enterprise.
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