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Universal SCORM/xAPI authoring freedom, built-in IEEE LRS, Part 11 e-signatures, and SOP retraining interlocks
Traditional corporate LMS platforms (Docebo, Cornerstone, TalentLMS) fail regulatory audits because they treat training as a casual checklist. Novaqis bridges universal e-learning content (SCORM 1.2, SCORM 2004, xAPI/cmi5) authored in Articulate 360, Adobe Captivate, and iSpring with FDA 21 CFR Part 11 compliant digital signatures, a native built-in IEEE 9274.1.1 LRS ($15k–$40k/yr savings), and automated SOP revision retraining interlocks.
Product preview
Facial mesh tracking, page dwell, and identity continuity during governed SOP reading
3. Sampling and testing
Collect samples per the approved plan before batch release. Document any deviation from the sampling schedule in the batch record and notify QA within one working day.
3.1 Retain samples
Retention quantities must match the effective specification attached to the product master.
Technical Architecture
Each capability is built directly into our shared regulatory fabric, eliminating integration glue and validation rework.
Upload any course built in Articulate 360 (Storyline and Rise), Adobe Captivate, iSpring Suite, or Lectora Online. Dynamic imsmanifest.xml parsing detects custom entry points (story.html, index_lms.html, scormdriver/indexAPI.html) with dual SCORM 1.2 & 2004 runtime adapters.
Eliminate $15,000–$40,000/year in standalone LRS subscriptions (Watershed, Rustici Engine). Novaqis includes certified IEEE 9274.1.1 endpoints (/xapi/statements, /xapi/activities/state) natively in the core platform with sub-millisecond statement streaming.
Trainees cannot simply reach the final slide to be certified. Every course completion triggers a statutory Part 11 e-signature modal capturing intent manifest, login credentials, quiz score, and cryptographic audit hash.
When controlled documents become effective in Novaqis DMS, retraining assignments flow automatically. Novaqis BRM and LIMS verify qualification in real time, preventing uncertified operators from executing active batch steps.
Eliminate collusion on shared plant terminals: deterministic per-attempt question bank sampling and distractor (A/B/C/D) reshuffling ensure questions and answer options are uniquely randomized per attempt, paired with webcam presence verification.
Run instructor-led and on-the-job sessions in governed virtual rooms: schedules, trainer controls, attendance capture, and completion evidence that rolls into competency matrices without exporting to spreadsheets.
Same users, roles, sites, and product licensing from Novaqis Admin. One SSO, one audit vocabulary, one validation narrative from training through quality and documents.
Enterprise Outcomes
Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.
Zero launch 404s across all major authoring suites (Articulate, Captivate, iSpring)
Eliminate $15k–$40k/yr in third-party LRS middleware fees
Legal non-repudiation with 21 CFR Part 11 e-signature gates on course pass
Continuous shop-floor qualification interlocks with BRM and LIMS
