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End-to-end carton, foil, label, and package insert proofing with character-level text diffing, pixel comparison, and QMS change control interlocks
Packaging artwork errors account for over 50% of commercial pharmaceutical recalls worldwide, resulting from uncoordinated SmPC revisions, manual proofreading fatigue, and unverified prepress print files shared over email or messaging apps. Novaqis delivers a dedicated, 21 CFR Part 11 validated Pharmaceutical Artwork Lifecycle platform. Unify carton die-lines, blister foil repeats, labels, and Package Inserts (PIL) with automated character-level text comparison, vector/pixel PDF diffing, Pantone shade card sign-offs, and hard fail-closed interlocks tied directly to Novaqis QMS Change Control.
Product preview
Vector overlay and character-level inspection comparing approved SmPC against prepress print files
| Authority / Territory | Product & Strength | Format | Contract CDMO | Status | Renewal Alert |
|---|---|---|---|---|---|
| Saudi Arabia (SFDA) | Novapressin 40mg Tab | GCC Centralised | Apex Formulations (Plant 02) | Approved | 90 Days (Due Nov 2026) |
| Philippines (FDA) | Novapressin 40mg Tab | ASEAN ACTD | Medispan Parenterals | Approved | 180 Days (Active) |
| Uzbekistan (SSPHC) | Novapressin 40mg Tab | National | Apex Formulations (Plant 02) | Query Responded | Submission Under Review |
| Kenya (PPB) | Novapressin 40mg Tab | EAC Harmonized | Apex Formulations (Plant 02) | Approved | 30 Days (Urgent Action) |
Technical Architecture
Each capability is built directly into our shared regulatory fabric, eliminating integration glue and validation rework.
Every packaging element (carton, label, blister foil, package insert) is governed by strict version control (Rev 01 → Rev 02). Artwork revisions cannot advance to commercial printing without an authorized, cryptographically signed Change Control record from Novaqis QMS.
Bring Regulatory Affairs (RA), Quality Assurance (QA), Medical/Legal, contract manufacturing sites (CDMO), and external packaging printers into a single collaborative review canvas. Capture inline annotations, die-line approvals, and dual-signature authorizations under Part 11 compliance.
Eliminate manual word-by-word proofreading. The system automatically inspects printer PDF proofs against approved SmPC, CCDS, and Package Insert masters, flagging font discrepancies, missing statutory warnings, dosage alterations, and punctuation shifts in seconds.
Overlay prepress graphic files against approved previous revisions or CAD die-lines with color-coded difference heatmaps. Detect millimeter-level shifts in glue flaps, embossed braille layouts, barcode positions, and color separation plates.
Govern physical prepress parameters digitally: register Pantone color specifications, varnish requirements, and gravure/flexographic printing cylinder IDs with sign-off workflows before commercial production commences.
When Rev 02 is released, Rev 01 is automatically flagged as obsolete across all connected plants. Novaqis BRM and eLog enforce electronic line clearance checks, preventing packaging lines from running decommissioned foil or carton batches.
Compliance & control
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
Automated diffing between approved text in SmPC/PI and the printer's graphic PDF proof catches minute character or font size errors.
Graphic overlays with opacity toggle highlight shifts in cutting lines, crease rules, braille dot placement, and color plates.
Artwork release requires an approved Change Control number and dual QA/RA electronic signatures.
Captures physical color shade card approvals, delta E spectrophotometer tolerances, and cylinder IDs.
Enterprise Outcomes
Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.
Eliminate packaging-induced pharmaceutical product recalls and scrap
Reduce artwork approval cycle times from 45 days to under 7 business days
100% automated catch rate for omitted statutory statements and die-line shifts
Direct audit defense with complete 21 CFR Part 11 revision history and e-signature logs
Unified coordination between brand marketing, regulatory affairs, external printers, and CDMOs
FAQ
