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Artworks Decision

Artwork approval and packaging project management for pharmaceutical labeling, with version control and regulatory compliance tracking.

Solution by SolutionsMax
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Overview

Artworks Decision is a packaging project management platform developed by PharmaMax Ecosystem Solutions, designed for regulated industries including pharmaceuticals, biotech, healthcare, and consumer packaged goods (CPG). It centralises artwork and packaging workflows across multiple stakeholders — including SKU managers, dieline creators, copy text developers, translation agencies, pre-press studios, printers, and suppliers — to support regulatory compliance and on-time product releases.

The platform covers the full lifecycle of pharmaceutical packaging artwork, from initial mock-ups and new product launches through to print-ready files, supporting packaging types such as folding boxes, patient information leaflets (PIL), summary of product characteristics (SmPC), blister foils, and multi-language projects for EU and other markets.

Artwork Approval Workflows

  • Initiate artwork projects and attach relevant files for review.
  • Route artworks to designated reviewers with defined roles and responsibilities.
  • Approve or reject artworks within the platform.
  • Automated email alerts notify stakeholders of pending tasks.
  • Track the status of artworks across all stages to keep teams aligned.
  • Customisable workflow configuration to match organisational approval processes.
  • Automated notifications and reminders to maintain approval timelines.

Asset Library

  • Centralised repository for storing dielines, artworks, packaging specifications, and regulatory documents.
  • Keyword tagging for searchability across the asset library.
  • Automatic version management to track changes and maintain version history.
  • Thumbnail previews for quick file identification.
  • Browse files via folder structure or filter using metadata.
  • Access controls to restrict viewing or modification to authorised personnel.

Collaboration and Proofing Tools

  • Checklists and annotation tools to support review and reduce rework cycles.
  • Barcode, font, colour, and layer verification within artworks.
  • Version comparison tools to identify differences between artwork iterations before sign-off.
  • Real-time collaboration features for cross-functional teams including regulatory, design, production, and quality assurance.
  • Commenting tools to facilitate communication during the review and approval process.

Reporting and Metrics

  • Real-time data insights into project and workflow status.
  • Identification of bottlenecks and causes for rework within the approval process.
  • Monitoring of project progress and compliance metrics.
  • Customisable reports on approval status and packaging project timelines.
  • Data analytics tools to support trend analysis and process improvement.

SKU and Dieline Management

  • SKU creation and management tools with hierarchical organisation for navigation and tracking.
  • SKU relationship mapping to understand dependencies between different product versions and packaging variants.
  • Dieline creation, editing, version control, and history tracking.
  • Integration with design software to support collaboration between design and production teams.

Supplier Collaboration

  • Supplier portal for communication and coordination with external partners.
  • Integration with supplier systems to support order processing and material tracking.
  • Tools to assess and monitor supplier performance.

Audit Trails and Compliance

  • Comprehensive audit trails logging all changes, approvals, and communications related to packaging projects.
  • Support for regulatory compliance audits through transparent activity records.
  • Integration with regulatory databases and tools to stay current with industry standards.
  • Automated checks to verify that packaging designs and materials meet regulatory requirements.
  • Supports compliance with FDA and EU submission regulations, including multi-language pharmaceutical artwork requirements.

Additional Platform Capabilities

  • Project planning and scheduling tools to manage timelines across packaging projects.
  • Task assignment and progress tracking across teams.
  • Quality assurance checklists and automated quality control checks during the approval process.
  • Mobile-friendly interface with mobile approval capabilities for remote access.
  • Integration with Enterprise Resource Planning (ERP) systems for data exchange and synchronisation.
  • Security features including encryption, user authentication, and regular security audits.
  • Training resources and documentation available within the system.

Implementation Approach

  1. Learn: Understand the organisation's specific needs and existing processes.
  2. Plan: Develop a deployment plan aligned to regulatory and operational requirements.
  3. Deploy: Implement the platform with customisation based on organisational needs.
  4. Support: Provide ongoing support to maintain system performance and compliance.

Artworks Decision is described as customisable to specific organisational requirements and is positioned as compliant with various regulatory agency standards. The platform is offered by PharmaMax Ecosystem Solutions, with offices in the USA (Princeton, NJ and Sacramento, CA) and India (Hyderabad, Visakhapatnam, Chennai, and Trivandrum).

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Quality Management System (QMS)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechMedical Devices
Development stage(s)
ManufacturingPost-Market & RWE
Target user(s)
Lab Manager / Core Facility ManagerQA / Regulatory Affairs
Compliance standard(s)
21 CFR Part 11GxP