Artwork Versioning & Pack Change Control

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated December 2025 • Labelling Governance, GS1, Claims, QMS & MES/WMS Integration • Food & Beverage, CPG, Personal Care, Household, Supplements, Pharma & Devices

Artwork versioning & packaging change control is the discipline of managing every change to labels, cartons, inserts and pack graphics under formal control – with version IDs, approvals, effective dates and system updates that keep packaging, master data and production all telling the same story. It is where “marketing wants a quick tweak” collides with labelling control & artwork changes, change control, GS1 GTIN rules and regulatory expectations. If artwork and pack changes are casual, your traceability, claims and recall posture are casual too – whether you admit it or not.

“If nobody can tell which artwork version is on which lot without opening boxes and guessing, you don’t have packaging control – you have expensive cardboard with opinions.”

1) What Artwork Versioning & Pack Change Control Actually Does

Artwork versioning & packaging change control makes packaging assets behave like any other controlled specification. For every SKU and market, it defines:

• Which artwork components exist (front label, back label, leaflet, carton, foil, wrap, display shroud, etc.).
• Which version of each component is current, approved and effective.
• What changes were made (text, claims, graphics, regulatory blocks, barcodes) and why.
• Which batches, lots, sites and markets used each version.

Change control then adds the process side: who can request, approve, implement and verify artwork and packaging changes; how risks are assessed; how systems and inventory are updated; and how old versions are retired. Together they give you a single, defensible answer to “what was on the pack?” for any lot and market, instead of a scramble through email archives and designer folders.

2) Why Artwork & Packaging Changes Are So Risky

Packs look harmless, but they carry a long list of risks:

• Regulatory: Incorrect or missing statements under 21 CFR 101, cosmetics and MoCRA rules, medical device and drug labelling requirements, local language and warning mandates.
• Safety & allergens: Undeclared allergens, wrong dosage or usage instructions, out-of-date safety info.
• Traceability: Wrong GTIN, lot, expiry or barcode symbology breaking traceability, recall readiness and retailer scans.
• Commercial: Misaligned promotions, wrong pack declarations, “off-brand” graphics or conflicting claims across channels.

Most serious label-related recalls, import holds and retailer delistings boil down to artwork and pack changes not being controlled, versioned and communicated properly. “We only changed the back panel” has blown up more than one brand when QA and Regulatory hear about the change from the market instead of from the workflow.

3) Relationship to Labelling Control, Claims and Regulatory Files

Artwork & pack change control sits on top of:

• Labelling & claims governance: As defined in labelling control & artwork changes.
• Regulatory dossiers & safety files: What products are authorised to say and where.
• Product profiles: Ingredients, allergens, nutritional panels, warnings and usage instructions.

Every artwork version should be traceable back to a controlled text and claims source – not be its own source of truth. When a claim, ingredient or regulatory requirement changes, the core text/spec is updated, and linked artwork versions are changed and re-approved under change control. If artwork is changed directly in a design file without referencing or updating these upstream sources, you’ve just created divergence that QA and Regulatory will eventually have to explain to someone in a suit with a badge.

4) Core Building Blocks – IDs, Versions, Libraries and Links

Good artwork versioning is largely a master-data problem. You need:

• Unique IDs for each artwork component (front label, bottle label, carton, leaflet, insert, display wrap, etc.).
• Version numbers and statuses (draft, under review, approved, obsolete) per component.
• Artwork libraries by SKU, market, language and pack-size family.
• Linkage between artwork IDs and GTINs, SKUs, products & formulas and regulatory text blocks.

Whether this lives in PLM, an artwork management system, ERP or a carefully curated doc management tool, the principles are the same: no orphan art files; every version traceable; every pack on the line mapped back to a controlled version ID that appears in your specifications and, ideally, in your batch record / packaging record.

5) Change Control – From “Idea” to “On the Line”

Packaging change control should feel familiar if you’ve ever run process or formula changes under a QMS. A basic flow:

• Initiation: Marketing, Regulatory, QA, Supply Chain or a customer requests a change.
• Impact assessment: Review of regulatory, claims, GTIN, artwork element, inventory, stability and system impacts.
• Approval: Cross-functional sign-off under change control – often QA + Regulatory + Packaging + Supply Chain at minimum.
• Implementation: Artwork creation, proofing, vendor changes, system and BOM updates, line validation where needed.
• Effectiveness check: Verification on the line and in WMS/MES that only new versions are used after the go-live date.

All of this belongs in the QMS, not in email threads. “We changed the label because the retailer asked us to last week” is not change control; it’s scope creep with legal consequences baked in.

6) GTIN, Pack Size and When a Change Needs a New Code

Packaging and artwork changes sometimes require new identifiers. Key considerations:

• Does the change affect consumer perception (size, count, quantity, functionality) enough to warrant a new GTIN per GS1 rules?
• Does the change materially affect regulatory status, such as claims, usage, ingredients or warnings?
• Will the change impact logistics (dimensions, weights, pallet patterns) used by retailers and 3PLs?

Artwork versioning & pack change control must integrate with GTIN governance. Sometimes a text or colour tweak can ride under the same GTIN; sometimes a “simple” formulation and claim change requires a new GTIN and updates to case labels, SSCCs, ASNs and customer item files. Guessing wrong here creates a long tail of data and scan failures.

7) Integration with MES, WMS and Printer Set-Up

Artwork and packaging decisions are only real when they hit the line and the warehouse. Integrations typically include:

• MES / line control: Jobs carry the correct artwork + label template IDs; hard-gating prevents start-up with mismatched versions.
• Printers & coders: Templates and content (GTIN, lots, dates, regulatory strings) are downloaded from controlled sources, not typed locally.
• WMS: Packaging BOMs and packaging BOM references align with current versions; old components are blocked when obsolete.

When these integrations are weak, “wrong label” and “wrong code” incidents multiply – even if the artwork library itself is beautifully governed. The pack room is where you find out whether your change-control process actually changed anything, or just generated a PDF that nobody implements.

8) Effectivity, Sell-Through and Mixed Inventory

Artwork versioning always lives in a world of “old vs new” stock. A workable strategy answers:

• From which batch or production date does the new version become mandatory?
• How will you handle existing printed packaging and finished goods inventory?
• Are there any markets or customers that must flip earlier (or later) than others?

Many organisations use batch or lot-based effectivity (e.g. “all batches from X onwards use v3.2”), sometimes tied to hold / release rules. WMS and MES need visibility of which version each pallet or batch carries, so that you can respond accurately to “which lots carried the old text?” questions during complaints, audits or recalls. “We think we finished the old labels in March” is not traceability – it’s hope.

9) Co-Packers, CMOs and Artwork Governance

Artwork and pack changes often involve external parties:

• Artwork agencies and pre-press providers.
• Printers of labels, cartons, foils and shippers.
• Co-packers and CMOs doing actual filling and labelling.

Quality agreements and technical contracts must clearly define who owns master artwork, who may update what, how approvals are communicated, and how obsolescence is handled. Allowing printers or co-packers to “fix text” or “adjust layout” locally without running through your change-control process is a fast route to unapproved claims, regulatory gaps and inconsistent packs across markets and channels.

10) Data Integrity, Approvals and Audit Trails

Artwork & pack change records carry the same data-integrity expectations as any other regulated decision:

• Every version should have a clear history – who changed what, when, and why.
• Approvals should use traceable signatures (electronic or physical) from defined roles (Regulatory, QA, Marketing, Packaging, etc.).
• Changes linked to deviations, complaints or CAPA should reference those records explicitly.
• Obsolete versions should be locked from further use, not just “moved to an old folder”.

When artwork is managed ad hoc in shared drives or email, it is almost impossible to reconstruct this history reliably. That becomes painfully obvious when regulators or customers ask for evidence that a specific change was assessed properly or that a pack involved in an incident was using the intended text and graphics for that market and date.

11) KPIs and Continuous Improvement for Artwork & Pack Changes

Artwork and pack change control should have metrics like any other core process. Useful KPIs include:

• Number of packaging- or label-related deviations and complaints per million units.
• Average cycle time from change request to artwork approval and then to implementation.
• Incidents of “wrong version on line” or “wrong label shipped” by site and SKU.
• Percentage of SKUs with current, mapped artwork versions and effectivity data.
• Obsolescence and scrap generated by packaging changes (cost of poor change control).

These metrics help you see whether your governance is practical and respected or bureaucratic and bypassed. If label-related incidents are high or static and cycle times are long, the honest conclusion is that your process design, not just user behaviour, needs fixing.

12) Common Failure Modes and Red Flags

Weak artwork versioning & pack change control leaves a trail you can spot from the car park:

• Multiple “current” PDFs for the same label in different folders, none clearly versioned.
• Production using printed artwork that doesn’t match any formally approved file.
• GTINs, allergen statements or warnings on pack that differ from specs and systems.
• Complaints or recalls where nobody can say exactly which text version was on which lot.
• Co-packers and printers holding their own “latest” version that doesn’t match yours.

Auditors know these red flags well. When they appear, the conclusion is simple: artwork and packaging are not under the same level of control as formulations, processes and testing – which makes your overall quality and compliance story a lot less convincing than the slide deck suggests.

13) Digitalisation & Industry 4.0 – Artwork as Master Data

In a more connected, data-driven world, artwork and pack specs are first-class master data, not attachments:

• Artwork systems feed structured data (claims, symbols, regulatory blocks, allergens) into ERP, MES, WMS and e-commerce platforms.
• Version IDs appear in batch records, EPCIS events, mock recall tools and product information management (PIM) systems.
• Digital “twins” of packs are used across labelling, artwork, web, GS1 data pools and B2B exchanges, all driven from one source of truth.

That only works if artwork versioning & change control are solid. If the digital supply of pack data is inconsistent, your “smart” labelling and traceability initiatives will faithfully replicate that inconsistency at scale – and partners will notice. Sorting out artwork governance is a precondition for serious digital transformation in CPG and regulated packaging, not a side quest.

14) Where Artwork & Pack Change Control Touches Traceability

Artwork and pack changes intersect traceability and recall in multiple ways:

• Recalls driven by labelling errors or missing warnings.
• Confusion over which lots used which label, making recall scope hard to define.
• Mixed use of old and new barcodes or GTINs across the same date range.
• EAN/UPC or GS1-128 content changes breaking retailer scan and ASN alignment.

Solid artwork versioning & packaging change control makes these recalls and investigations faster, narrower and easier to explain. Weak control ensures that you will spend more time arguing about what was on the pack than fixing the underlying issue – and that customers and regulators will trust your answers less when timing matters most.

15) FAQ

Q1. Does every artwork tweak need to go through full change control?
Not every adjustment needs the same level of scrutiny, but every change should go through some formal path. A risk-based model can differentiate “administrative” changes (e.g. minor layout tweaks that don’t impact content or scannability) from substantive changes (ingredients, allergens, claims, regulatory statements, GTINs, barcodes). The key is that risk classification, not convenience, drives which path is used – and that even “minor” changes are recorded and versioned.

Q2. How do we decide when a packaging change requires a new GTIN?
Use GS1 rules and internal policy: changes that alter net content, dimensions, declared quantity, consumer perception of the product, or how it is traded/logistically handled often require a new GTIN. Subtle text or legal changes may not. Your artwork & pack change process should include a GTIN impact check by someone trained in GS1 standards; guessing based on “what we did last time” is how scan failures and data inconsistencies proliferate.

Q3. Can printers or co-packers manage artwork master files on our behalf?
They can host and print from artwork files, but the authoritative source and version control should remain with the brand owner or the designated central artwork system. External partners should only use approved versions referenced by unique IDs, and any proposed changes must come back through your change control process. Allowing partners to maintain their own “current” art outside your QMS usually ends in version drift and inconsistent packs across markets.

Q4. How do we handle old printed packaging when artwork changes?
Options include controlled run-out, relabelling/over-labelling, downgrade/different markets, or scrap – but the decision should be risk-based and documented. Factors include regulatory deadlines, claim changes, allergen or safety relevance, retailer tolerance and inventory levels. Whatever path you choose, you must be able to say which lots were packed in old vs new artwork and why that was acceptable, with corresponding entries in WMS, QMS and, if necessary, Regulatory records.

Q5. Where should we start if our artwork lives in shared folders and email?
Start by freezing the chaos for one product family or key customer: identify the “true” current artwork components, assign them IDs and versions, and log them formally in your QMS or a simple artwork register. Then design a lightweight change-control workflow for that scope – request, assess, approve, implement, communicate – and integrate basic version references into BOMs, specs and packing instructions. Once this pattern proves workable and reduces label-related issues, extend it to more SKUs and sites; avoid trying to clean up the entire historical artwork universe in one pass.

Related Reading
• Labelling & Claims: Labelling Control & Artwork Changes | GS1 GTIN | Application Identifier (AI) | GS1-128 Case Label
• Systems & Governance: Quality Management System (QMS) | Change Control | Products & Formulas | Packaging Bill of Materials (BOM)
• Traceability & Events: Traceability – End-to-End Lot Genealogy | Recall Readiness | Mock Recall Performance