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21 CFR Part 11 electronic batch records, sterile cleanroom eLog, 22-module QC LIMS, and automated training gates for RTP life sciences manufacturers
As North Carolina's Research Triangle Park (RTP), Holly Springs, and Clayton hubs expand as global leaders in biologics, gene therapy, and sterile fill-finish, manufacturers face intense FDA scrutiny on data integrity and batch disposition speed. Novaqis provides a unified GxP platform—Dynamic eBR with Review-by-Exception, 6-state cleanroom eLog™, and 22-module paperless LIMS—with zero per-seat user taxes and 100% on-premise or private VPC sovereignty.
Technical Architecture
Each capability is built directly into our shared regulatory fabric, eliminating integration glue and validation rework.
Autologous and personalized therapies require rapid release. Novaqis Review-by-Exception checks 100% of Critical Process Parameters in real time, dropping QA review from 14 days to under 4 hours.
Autonomous 6-state eLog™ monitors particle counter integrations, clean-hold countdown timers, and airlock cascading for sterile fill-finish suites across RTP facilities.
Strict data isolation and client-specific master formula governance allow contract manufacturers to manage multiple sponsor pipelines within one validated system.
Eliminate unvalidated Excel worksheets with dynamic formula calculations, automated volumetric solution standardization, and bidirectional SAP QM integration.
Compliance & control
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
ES256 asymmetric signature envelopes with dual-witness credentials and tamper-evident audit logs.
Dynamic eBR automatically locks batch execution until eLog confirms verified cleanroom sanitization.
Prevents operators with expired SOP training from executing critical formulation or dispensing steps.
Enterprise Outcomes
Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.
Slash batch disposition cycles from 14 days down to 4 hours with Review-by-Exception
Eliminate FDA 483 data integrity risks under 21 CFR 211.68 and 211.192 with cryptographic audit trails
Deploy with pre-executed GAMP 5 Category 4 validation packs in under 60 days
Site-wide enterprise licensing: expand across operators and lab analysts without per-user seat penalties
FAQ
Eliminate the 12-month Computer System Validation (CSV) nightmare. Novaqis delivers pre-executed IQ/OQ protocols, automated regression test suites, and turnkey traceability matrices configured for modern life sciences.
Pre-executed verification of microservice container signatures, database schema hashes, and network isolation.
Automated regression testing of 21 CFR Part 11 e-signatures, audit log immutability, and eLog cleanroom state machines.
100% mapping of user requirements (URS) through functional specs (FS) to automated and scripted test results.
Risk-based testing classification focusing validation rigor on high-impact patient safety and product quality paths.
Request a redacted validation dossier to evaluate our GAMP 5 Category 4 evidence with your QA and CSV team.
