Work Within the Regulations of a cGMP Compliant Environment
Esko’s labeling and artwork management system enables you to adhere and adapt to US FDA, EU EMA, and other government regulations regarding audits, system validations, audit trails, electronic signatures, and documentation. There are significant challenges to working without Esko’s system.
Complex SOPs
Many parties are involved in the creation and review cycles of labeling content and artwork, and that leads to complex processes and tracking methods. Every Life Sciences company has SOPs, but inefficiencies and manual processes introduce risk into the process.
Manually Intensive Ways of Working
Manual touchpoints, by their very nature, present opportunities for errors to slip into the process. They also present challenges with tracking things like reviews, change requests, checklists, and all of the related documentation needed.
Lack of Traceability
It’s hard to determine what’s happened when you don’t have a clear, full picture of the history. Especially when a Health Authority is (im)patiently waiting for audit results.
