Open GxP Architecture: How Novaqis Seamlessly Integrates with Third-Party ERP, LIMS, MES, CDS & IAM Systems

For decades, legacy life sciences software providers locked pharmaceutical manufacturers into proprietary, closed ecosystems. Integrating a third-party chromatography system or enterprise ERP required expensive, custom-coded point-to-point scripts that broke during every software update and created massive validation re-work.

Novaqis is engineered from the ground up on an open, API-first architecture (.NET 10 microservices with standardized OpenAPI 3.0 endpoints). Whether operating in the cloud or in an air-gapped on-premises plant network, Novaqis provides verified, secure, and bidirectional interoperability with existing enterprise systems.

Novaqis provides native connectors for enterprise resource planning platforms: • SAP S/4HANA & ECC Integration: Ingests SAP inspection lots (01 raw materials, 04 in-process/finished goods, 05 stability) directly into Novaqis LIMS worksheets. Upon final QA disposition, Novaqis automatically transmits Usage Decisions (UD) and stock postings back into SAP without manual re-entry. • Raw Material Reservation & Mass Balance (BRM): Electronic batch records (BRM) verify barcode scanning of active pharmaceutical ingredients (APIs) and excipients against ERP warehouse inventory, locking out expired or unreleased lots.

Eliminating manual data transcription from laboratory instruments is paramount for 21 CFR Part 11 and ALCOA+ compliance: • Chromatography Data Systems (CDS): Direct bidirectional interfacing with Waters Empower 3, Thermo Fisher Chromeleon 7.3, and Agilent OpenLab CDS. Novaqis LIMS pushes sample sequence lists directly to the CDS and ingests peak retention times, peak areas, and calculated assay percentages automatically. • Weighing Balances & Physical Testing: RS-232 and TCP/IP network integration with Mettler Toledo and Sartorius analytical balances, automatic titrators, and digital density meters, capturing gross/tare weights with verified electronic audit trails.

Bridging plant automation and corporate enterprise IT: • Industrial Plant Historians (OSIsoft PI & Aveva): Continuous streams of cleanroom differential pressure, HVAC temperature, and humidity sensors flow directly into Novaqis LIMS Environmental Monitoring modules, triggering automated out-of-limit deviation workflows in QMS. • Enterprise Single Sign-On (IAM): Native SAML 2.0, OAuth2, and OIDC connectors for Microsoft Entra ID (Azure AD), Okta, Ping Identity, and on-premises Active Directory/LDAP, enforcing role-based access control (RBAC) and 21 CFR Part 11 compliant re-authentication signatures.