How to build and implement an eQMS: efficiency, compliance and data integrity – Replay

Applications / Use cases / Artworks: Management of packaging items and promotions

Use case

Artworks: Management of packaging items and promotions

Management and validation of Artwork in-house up to the publication for the printer (subcontractor) for an international pharmaceutical company, with a 20% time-saving in validation.

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image of artworks management

Context of the digitalization request

A pharmaceutical company, which manufactures, distributes, and promotes its brands in 75 countries worldwide needs a solution to manage promotional and institutional media, with a process for checking and approving packaging items for its products right through to the publication of a final proof for the printer (subcontractor).

Challenges

Multiplication of packaging and advertising items, with local and regional constraints to be respected, and management of multiple versions following changes in local and international regulations.

A single platform is needed to centralize the management of packaging, training, and advertising items and a system supporting the required languages and typographies..

The application solution

An application to manage and control the verification and approval workflow for :

  • Various packaging items (boxes, leaflets, labels, etc.)
  • Training for healthcare professionals
  • Advertising aimed at healthcare professionals

Management by regulatory affairs through an approval system (multi-level workflow), right up to creating a ready-to-print (RTP) for the subcontractor when necessary.

The customer and end-users contributed to developing and enhancing the solution, which meets compliance requirements, manages user access, and ensures data integrity.

Artworks Application

GxpManager

More information

Key features

  • Advanced search tool
  • Audit trail: every data addition, modification, or deletion is tracked
  • Access management: 90% of users have limited read-only access, while 10% have administrator access and can make modifications.

The benefits

An application that saves users 20% time in approving packaging items, thanks to the centralization of all elements on a single platform.

  • Access management for all users
  • Management of mandatory data entry
  • Control of the approval process with electronic signature
  • Audit trail for tracking modifications
  • Version control for packaging items and promotional materials
  • Creation of publication in 1 click
  • Supplier Management

The solution was implemented over eight (8) weeks, with an initial workshop and four (4) sprints. The customer had access to the application between sprints to test it and request changes according to usage and requirements.

Results

  • 20% time-saving on approval of packaging items
  • Reduced time in the validation process for promotional materials by 30 %.
  • Simplified international regulatory affairs collaboration using a single platform.
  • Training follow-up simplified for healthcare professionals.

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