GMP compliance in pharmaceutical packaging & labeling

A key issue for highly regulated industries like pharmaceuticals and life sciences is compliance and adherence to the guidelines and principles of current Good Manufacturing Practices (GMP).

WebCenter QuickStart for Brands is a dedicated management system for GMP labeling and packaging artwork change management. WebCenter helps companies maintain GMP in the pharma industry.

Is WebCenter QuickStart for Brands GMP compliant?

About GMP software validation & GMP labeling requirements

Any software solution provided to a company in these industries must be GMP validatable (often referred to as ‘GMP compliant’), specifically ERES (Electronic Records, Electronic Signatures) regulations, and the vendor must be able to demonstrate that the software has been developed to contain all the necessary technical controls to ensure it meets these requirements.

Regarding GMP packaging and labeling requirements, Esko WebCenter has been developed according to GAMP5 (Good Automated Manufacturing Practices) guidelines with all the necessary technical controls in place to ensure it is fully validatable.

WebCenter QuickStart for Brands meets the GMP Pharma requirements of: FDA 21 CFR Part 11, and Eudralex EU GMP Annex 11 guideliness.

This includes ERES (Electronic Records, Electronic Signatures) and full audit trail capability.

Esko WebCenter enables Pharma and Life Science companies to effectively manage their regulatory content and artwork portfolio including pre-production specifications, content, graphics, and artwork files in a GMP compliant and secure way.

WebCenter allows you to optimize and standardize processes across all stakeholders, departments and suppliers. This will allow you to maintain absolute control over all of your artwork assets and copy, bringing consistency, repeatability and reliability to your packaging workflow.

Powerful label and artwork
management software.

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