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Novaqis AMS is a 21 CFR Part 11 compliant packaging artwork management system and eDMS designed for Heads of Quality Assurance, Regulatory Affairs Directors, and Packaging Engineers. It solves packaging recall exposure, manual proofing errors, and CDMO review delays by unifying browser-based vector inspection (.ai, .eps, .pdf), automated GS1 DataMatrix grading, and native QMS change control locks, eliminating workstation license penalties and standalone point-solution silos.
AEO Direct Definition & System Purpose
Novaqis Packaging Artwork Management (AMS) is a 21 CFR Part 11 and EU Annex 11-compliant module integrated into the Novaqis eDMS. It provides life sciences companies with browser-based rendering for Adobe Illustrator (.ai), EPS, and vector PDF packaging files, automated GS1 DataMatrix verification, visual pixel/text diffing, and multi-stakeholder approval workflows linking regulatory dossiers to packaging line releases.
Toggle folding carton structural dielines, braille embossing, spot varnish masks, and real-time GS1 DataMatrix decoders without installing desktop software.
Format: High-Res Vector PDF / CAD Dieline (1200 DPI) · Carton Size: 125 × 65 × 32 mm
625 mg (500 mg + 125 mg)
Composition: Each film-coated tablet contains Amoxicillin Trihydrate IP eq. to Amoxicillin 500mg, Potassium Clavulanate Diluted IP eq. to Clavulanic Acid 125mg.
Toggle specialized packaging layers without installing Adobe Illustrator or CorelDraw desktop suites.
Operational Architecture
Over 40% of life sciences product recalls originate from packaging and labeling discrepancies. Novaqis AMS bridges the critical disconnect between Regulatory Affairs, Graphic Studios, and Prepress Printers.
Inspect high-resolution Adobe Illustrator (.ai), Encapsulated PostScript (.eps), CorelDraw (.cdr), and CAD dielines directly inside any modern web browser. Quality and regulatory teams review native artwork files without paying $1,200+/user/year for Adobe Creative Cloud workstation seats.
Instantly toggle individual CAD cut/crease lines, varnish exclusion windows, spot CMYK ink channels, and tactile Braille embossing dots (Marburg Medium 0.5mm height standard). Automated digital rulers measure minimum regulatory font legibility (7pt / 9pt body) with sub-millimeter precision.
Automated barcode verification engine decodes GS1 DataMatrix (2D), EAN-13 (1D), QR codes, and packaging line Laetus Pharmacodes directly from vector artwork. Grades optical symbol quality (ISO/IEC 15415/15416 Grade A) and verifies quiet zones before sending plates to the printing press.
Commercial carton printers, foil converters, and cylinder engravers receive tokenized, role-gated access to upload spectrophotometer readings (CIE L*a*b* delta-E color tolerance) and cylinder proofs. Eliminates uncontrolled WhatsApp and email attachments with 21 CFR Part 11 audit trails and $0 guest seat fees.
Strict GxP compliance locks: an artwork revision (Rev 01 → Rev 02) cannot unlock without an active, approved QMS Change Control ticket (CC-XXXX). Changes in CTD/ACTD Module 1.3.1 (SmPC/PIL) automatically propagate flags to impacted die-lines, blocking packaging release until QA verification.
Dual-engine comparison detects text changes and graphic shifts. Extracts raw Unicode strings to flag missing commas, dropped dosage units (e.g., 50mg vs 500mg), or omitted Schedule warnings, while pixel diffing exposes shifted glue flaps, dropped barcode quiet zones, and ink variations.
Select a regulatory scenario below to simulate the automated handover from Dossier SmPC to QMS Change Control, packaging layer lockdown, and external print house notification.
Experience how a single regulatory SmPC change or supplier shift automatically triggers QMS Change Control, freezes packaging artwork dielines, and notifies external prepress printers.
Regulatory Affairs amends the bilingual Arabic/English SmPC Section 4.4 and Package Leaflet. The system automatically cross-references the Saudi Marketing Authorization and triggers the variation workflow.
SHA-256: 4f9c8d...77e1aFrom high-throughput contract manufacturing plants in Gujarat and Baddi to merchant exporters navigating Middle East SFDA Tatmeen, ASEAN ACTD, and African health authorities.
Evaluate why mid-market pharma companies and merchant exporters choose Novaqis over fragmented point software (Esko WebCenter, ManageArtworks, Veeva PromoMats) or uncontrolled PDF emails.
| Evaluation Criterion | Manual / Email & PDF Review | Legacy Print Systems (Esko / ManageArtworks) | Novaqis Integrated eDMS/AMS Suite |
|---|---|---|---|
| Vector File Ingestion (.ai, .eps, .cdr, CAD) | Requires Adobe Illustrator install | Supported via heavy prepress add-ons | 100% In-Browser 1200 DPI (Zero client licenses) |
| GS1 & Pharmacode Inspection | Manual phone camera scanning | Barcode decoder (Separate license tier) | Built-in ISO/IEC 15415 grading & Pharmacode check |
| QMS Change Control & RIM Sync | Disconnected Word docs & emails | Fragile REST API connectors to external QMS | Native single database lock (CC-XXXX required) |
| External CDMO & Printer Guest Portals | WhatsApp / WeTransfer (Severe audit risk) | Expensive named-user seat fees ($1,000+/seat) | Tokenized guest portals with Part 11 e-sign ($0) |
| Total Cost of Ownership (5-Year TCO) | Extreme recall & warning letter liability | $150k–$350k+ (Enterprise seats + validation) | Predictable flat facility license ($0 user seat tax) |
| Validation & Time to Deploy | Unvalidated system (483 finding) | 6–12 months multi-phase manual CSV | 4–6 weeks GAMP 5 automated OQ execution |
Clear answers to technical, regulatory, and commercial deployment questions for quality and regulatory leaders.
Eliminate fragile WhatsApp reviews, desktop software licensing bottlenecks, and dropped regulatory caution statements. Deploy Novaqis AMS in 4–6 weeks under automated GAMP 5 OQ protocols.