How does a loan-license marketing entity demonstrate 21 CFR Part 11 compliance during regulatory audits?

Under US FDA 21 CFR §211.22, WHO TRS 961, and CDSCO Revised Schedule M, marketing authorization holders and loan-license operators retain ultimate legal responsibility for batch quality and record integrity. Novaqis provides the digital compliance backbone: every batch COA review, deviation evaluation, and artwork sign-off is captured in an immutable ALCOA+ audit trail with dual-credential electronic signatures, proving data integrity to international inspectors.

How do external CDMO manufacturing plants upload batch records and COAs into Novaqis?

External CDMO partners receive secure, role-restricted guest portal access at zero additional license cost. CDMO QA personnel upload batch manufacturing records, environmental monitoring summaries, and analytical test results directly into the system, where files undergo cryptographic hash verification and are placed into an automated quarantine holding state pending sponsor release.

Can commercial packaging printers view artwork without seeing sensitive formulation records?

Yes. Novaqis enforces strict role-based access control (RBAC). External packaging printers and prepress cylinder engravers only see the approved vector artwork file, structural CAD dieline, and color separation specs with dynamic anti-tampering watermarks. They have zero visibility into chemical formulation masters, batch records, or financial data.

How does Novaqis compare to Veeva Vault or TrackWise for virtual pharma companies?

Legacy enterprise monoliths like Veeva Vault and TrackWise charge $100k+ to $250k+ in baseline platform fees plus $3,000 to $5,500 per user per year. For virtual pharma and merchant exporters coordinating with 10–25 external partners, seat taxes make complete digitization financially impossible. Novaqis provides flat enterprise site licensing ($0 seat tax), native packaging artwork proofing built into eDMS, and 4–6 week deployment.

Which Indian pharma clusters and export destinations does Novaqis support?

Novaqis is actively engineered for India's major formulation and contract manufacturing hubs—including Gujarat (Ahmedabad, Vadodara, Surat, Ankleshwar), Himachal Pradesh (Baddi, Nalagarh), Maharashtra (Mumbai, Pune, Tarapur), and Telangana (Hyderabad)—as well as merchant export operations shipping to the Middle East (Saudi SFDA, UAE MOHAP), Southeast Asia (ASEAN ACTD), Africa (TMDA, NAFDAC), and the Eurasian Union (EAEU Decision 78).

Virtual Pharma & Loan-License Compliance

Loan-License & Pharma Marketing Compliance Software

Multi-CDMO Quality Oversight, External Batch COA Quarantine Release & Packaging Artwork Proofing Under 21 CFR Part 11.

Virtual pharmaceutical marketing entities, loan-license operators, and merchant exporters face an acute regulatory challenge: health authorities (US FDA, WHO, SFDA, CDSCO) hold the marketing authorization holder strictly accountable for batch quality and artwork integrity, even when physical manufacturing is outsourced. Novaqis provides a turnkey GxP suite unifying external CDMO batch release, packaging shade card proofing, and CTD/ACTD dossier lifecycle without recurring seat taxes.

21 CFR Part 11 & EU Annex 11
CDSCO Revised Schedule M (2024–2026)
WHO TRS 961 Annex 2 Governance
GAMP 5 Category 4 Configured
Multi-CDMO Zero Seat Tax

Book an Architecture POC Explore Packaging Artwork Suite

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)

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

External CDMO Batch Records & COA Quarantine Custody

Eliminate uncontrolled WhatsApp and unencrypted email exchanges between marketing offices and contract manufacturing plants in Gujarat, Baddi, Maharashtra, and Hyderabad. Contract manufacturing sites upload batch manufacturing records, stability pull sheets, and certificates of analysis (COA) directly into validated external portals, enforcing automated quarantine holds until formal QA sponsor authorization.