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.
Specifically in terms of GMP packaging and labeling requirements, Esko’s WebCenter solution 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 meets the requirements of
- FDA 21 CFR Part 11 guidelines
- Eudralex EU GMP Annex 11 guidelines
This includes ERES (Electronic Records, Electronic Signatures) and full audit trail capability.
GMP software validation of WebCenter is a given and GMP verification is not an issue. This provides you with peace of mind that WebCenter will perform according to your requirements and will significantly reduce your own levels of resource and effort involved in validation and verification.
WebCenter allows you to optimize and standardize processes across all stakeholders, departments and businesses. This will allow you to maintain absolute control over all of your assets and copy, bringing consistency, repeatability and reliability to the workflow.