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Solution · Global Regulatory Compliance
US FDA 21 CFR Part 11 & GxP Compliance Platform
Cryptographic e-signatures, immutable ALCOA+ audit trails, and pre-validated GAMP 5 execution packs
Navigating US FDA inspections requires demonstrable, tamper-proof electronic records and signatures. Novaqis delivers native 21 CFR Part 11 compliance across Document Management (DMS), Training (LMS), Quality Events (QMS), Laboratory Informatics (LIMS), and Batch Records (BRM) with pre-validated GAMP 5 documentation packages.
- 21 CFR Part 11 Ready
- ALCOA+ Data Integrity
- GAMP 5 CSV
- US FDA Audit Ready
Solution TelemetryGAMP 5 Cat 4
Validation Dossier:Pre-Scripted IQ/OQ
Deployment Footprint:On-Prem / Cloud Validated
Audit Architecture:SHA-256 Chained
Per-Seat Tax:$0 (Site License)
Product preview
See it in the platform
Cross-system compliance visualization and inspection rehearsal
Dashboard / Dashboard
Dashboard
Operations overview
Last updated: 6/15/26, 12:55 PM
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Roles
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Active sessions
1
7 functional groups in scope
Daily sign-ins
Site distribution and logins use Admin data for your scope.
Technical Architecture
Governed Operational Capabilities
Each capability is built directly into our shared regulatory fabric, eliminating integration glue and validation rework.
Core Engine21 CFR §11
21 CFR Part 11 Cryptographic E-Signatures
Enforce dual-credential password or passkey e-signatures with explicit manifestation of signer identity, title, and timestamp. Built-in meaning-of-signature prompts (Author, Reviewer, Approver, QA Release) compliant with §11.50 and §11.70.
Deterministic GxPValidated Module
Regulatory Integrity21 CFR §11
ALCOA+ Immutable Audit Trails
Automated, computer-generated time-stamped audit trails capture every record creation, modification, status transition, and deletion attempt. Audit logs are independently indexed and exportable for instant regulatory presentation.
Deterministic GxPValidated Module
System Architecture21 CFR §11
GAMP 5 Validation Documentation (IQ/OQ/PQ)
Pre-configured, executed validation evidence packs and automated regression testing scripts aligned with ISPE GAMP 5 risk-based approaches, reducing CSV timelines from months to weeks.
Deterministic GxPValidated Module
System Architecture21 CFR §11
Shop-Floor Controlled Print Governance
Eliminate 483 audit observations with copy-numbered issuance, dynamic anti-counterfeiting pantograph security patterns, and dual-signed electronic destruction verification.
Deterministic GxPValidated Module
System Architecture21 CFR §11
AuditLens Inspection Room Mode
Project clean, tamper-proof record histories with one-click export of cryptographically signed PDF evidence packages directly during FDA investigator walkthroughs.
Deterministic GxPValidated Module
Compliance & control
Built for regulated operations
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
CapabilityHow Novaqis delivers it
- Electronic Signatures (§11.50, §11.70)
Password-backed signatures with distinct user identity, timestamp, and legal meaning-of-signature manifestation.
- Audit Trail Integrity (§11.10(e))
Immutable system-generated audit logs with NTP server time synchronization and secure storage.
- Authority Checks & Security (§11.10(d),(g))
Role-based access control (RBAC), multi-factor authentication, and automated session timeouts.
- Record Retention (§11.10(c))
Long-term cryptographic archiving with full searchability and export in PDF/A standard formats.
Enterprise Outcomes
Why Regulated Operations Standardize on Novaqis
Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.
Zero 483 audit findings for electronic records and signature integrity
Instant multi-system traceability during regulatory inspections
Turnkey GAMP 5 validation packages for every software version release
Complete data sovereignty with on-premises or private cloud deployment
FAQ
Frequently asked questions
- Novaqis enforces 21 CFR Part 11 controls natively at the platform architecture layer: secure cryptographic e-signatures, immutable ALCOA+ audit trails, role-based segregation of duties, and time-stamped record histories across all 6 core modules.