ISO/IEC 27001:2022
ISMS governance, access, monitoring, incident response and evidence mapping. An organization-wide certification is separate from product control implementation.
BayesPeaQ / Trust & Validation
Show the evidence.
Keep the limits visible.
BayesPeaQ is designed for traceable quality work in regulated pharmaceutical environments. The relevant controls, their verification evidence and the customer's intended-use validation deserve detailed review—not a compliance badge.
Different frameworks, distinct responsibilities
Standards inform the design. Evidence determines readiness.
No software feature alone establishes a company's certification, GxP suitability or regulatory acceptance. Qualification depends on intended use, configuration, procedures and customer risk assessment.
ICH Q10 & ICH Q9
Pharmaceutical quality-system lifecycle and risk-management principles help frame investigations, CAPA, management oversight and product decisions.
21 CFR Part 11
Electronic-record and signature expectations require context-specific assessment of access, audit trails, identity, validation and procedural controls.
EU GMP Annex 11
Lifecycle validation, access, electronic signatures, audit trails, business continuity, backup and data integrity are considered within a customer's qualification process.
Evidence boundary: References above describe relevant frameworks; they do not claim Bayes Pharma or BayesPeaQ holds a specific certification, nor that any deployment is automatically compliant.
Control-to-evidence discussion
What your validation team should inspect.
Review the control implementation and the exact, current evidence applicable to your configured environment.
Identity, roles & independence
Tenant and role boundaries, session behavior, reviewer qualification, authority and separation of duties.
Record integrity & provenance
Original observations, source versions, corrections, evidence relevance, retention and audit history.
Electronic signatures & review gates
Re-authentication, signature meaning, reviewer authorization, linked records and revocation behavior.
Qualified integrations
Source ownership, field mapping, duplicates, retries, correction propagation and reconciliation boundaries.
Resilience & controlled change
Release traceability, rollback readiness, recovery testing, monitoring and documented deviations.
Responsible evaluation
Validate against your workflow—not a generic checklist.
Share your intended use, deployment scope, roles, source-system boundaries and evidence expectations with the Bayes Pharma team. Evidence availability is subject to review and access permissions.
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