Compliance matrix
Requirement, Axon control, evidence produced and customer responsibility. Who provides what is kept explicitly separate.
Axon is designed to support the requirements below. This table is not a certificate, an approval or legal advice; compliance is achieved together with validation of the system at your site and your procedures.
System validation
21 CFR 11.10(a) · Annex 11 cl. 4
- Axon control
- Template and protocol execution module runs validation activities paperless.
- Evidence produced
- Signed protocol results, version history
- Customer responsibility
- Risk-based validation of your own Axon install (GAMP 5).
Authorized access
21 CFR 11.10(d),(g) · Annex 11 cl. 12
- Axon control
- Role-based permissions, identity-provider integration, segregation-of-duties checks.
- Evidence produced
- User and role records, access events
- Customer responsibility
- User lifecycle and role-assignment procedures.
Audit trail
21 CFR 11.10(e) · Annex 11 cl. 9
- Axon control
- Time-stamped, append-only records; SHA-256 chain; raw-payload visibility.
- Evidence produced
- Audit trail entries, chain verification output
- Customer responsibility
- Audit-trail review frequency and owner.
Signature manifestation
21 CFR 11.50
- Axon control
- Name, date/time and signature meaning (author, reviewer, approver) are held in the signature record.
- Evidence produced
- Signature record and on-document manifestation
- Customer responsibility
- Defining signature meanings in procedures.
Signature and record linking
21 CFR 11.70
- Axon control
- A signature is bound to its record by digest; altering a signed record breaks the chain.
- Evidence produced
- Record digest and chain verification
- Customer responsibility
- Revision procedure for changing signed records.
Identification and password controls
21 CFR 11.100, 11.200, 11.300
- Axon control
- Identity re-authentication at signing; identity-provider policies.
- Evidence produced
- Re-authentication events
- Customer responsibility
- Password policy, identity management and training.
Change and configuration management
Annex 11 cl. 10 · ICH Q10
- Axon control
- CCMS: impact assessment, QA decision, task lock, effectiveness verification.
- Evidence produced
- Change record, impact matrix, closure signature
- Customer responsibility
- Defining change-classification criteria.
Controlled documentation
EU GMP Chapter 4 · 21 CFR 211.100
- Axon control
- DMS: version control, periodic review, read-and-sign tasks, controlled copies.
- Evidence produced
- Version history, training signatures
- Customer responsibility
- Document hierarchy and review intervals.
Deviations and CAPA
21 CFR 211.192 · EU GMP Chapter 1
- Axon control
- CAPA: containment, root-cause analysis, VOE tracking.
- Evidence produced
- Deviation and CAPA records, VOE result
- Customer responsibility
- Root-cause methodology and decision authority.
Risk management
ICH Q9(R1)
- Axon control
- RISK: FMEA/RPN scoring, CPP and CQA traceability.
- Evidence produced
- Risk assessment records
- Customer responsibility
- Risk acceptance criteria.
Qualification and validation
EU GMP Annex 15
- Axon control
- VMS: IQ/OQ/PQ protocol execution, cleaning validation, statistical calculations.
- Evidence produced
- Signed protocols, calculation records
- Customer responsibility
- Validation master plan and acceptance criteria.
Personnel competency and Training Gate
21 CFR 211.25 · ISO 13485 cl. 6.2
- Axon control
- TRN: Automatic Read & Understand assignment on SOP revisions; Training Gate e-signature locking for unqualified staff.
- Evidence produced
- Quiz scoring records, e-signature gate log, competency matrix
- Customer responsibility
- Defining curricula and exam passing thresholds.
Complaints and vigilance incident reporting
21 CFR 820.35 · EU MDR cl. 87 · ISO 10002
- Axon control
- CMP: Batch linking, regulatory countdown clocks for FDA eMDR (5/30 days) and EU MDR MIR, direct CAPA bridge.
- Evidence produced
- Timestamped vigilance submission logs, triage scores, linked CAPA records
- Customer responsibility
- Designating vigilance officers and field escalation SOPs.
Supplier qualification and incoming inspection
EU GMP Chapter 7 · Annex 16 · ISO 2859-1
- Axon control
- SCM: Dynamic ASL, PO holds on expired audits, SCAR 8D workflow, ISO 2859-1 AQL inspection and GDP temperature logs.
- Evidence produced
- ASL approval records, SCAR verification, AQL acceptance logs
- Customer responsibility
- Supplier audit criteria and incoming AQL inspection levels.
Internal audits and health authority inspections
ISO 19011 · FDA QMSR · EU GMP Chapter 9
- Axon control
- AUD: Auditor segregation of duties (SoD), inspection room document retrieval log, FDA 483 commitment tracking engine.
- Evidence produced
- Audit reports, SoD verification proofs, commitment countdown logs
- Customer responsibility
- Approving annual audit programs and inspection committee SOPs.
Data retention and continuity
Annex 11 cl. 7, 16
- Axon control
- Backup and restore per deployment model; on-premise option.
- Evidence produced
- Installation and operations documents
- Customer responsibility
- Backup policy, retention periods, disaster-recovery plan.
What we do not claim
- FDA approval, EMA approval or third-party certification
- Automatic or absolute compliance
- Unsubstantiated performance or savings figures