Regulatory Compliance in Pharma

Compliance isn’t a nice-to-have. When it comes to using a system to manage labeling and artwork, it’s a requirement. The impact of being caught short can be enormous to patient safety and your business.

Life SciencesArtwork ManagementContent ManagementEnd to End LabellingPackaging DesignRegulatory Compliance

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.

A Content Management Solution Minimizes Risk

Validation

Validation activities are incorporated into the Esko Solution Implementation LifeCycle (SILC) for each deployment. Esko uses a validation package, consisting of our methodology and templates, which are purpose-built for a WebCenter implementation. The validation activities provide documented evidence and traceability to demonstration that WebCenter has been validated, according to a customer’s requirements, and that it is fit for its intended use.


Traceability

Life Sciences companies need to have a clear view of the history of labeling content and artwork for auditing purposes, and also must have a way to accurately determine what is impacted by a labeling change request. In other words, being able to look backwards and forwards is needed to reduce risk and minimize errors. This can only be achieved with consistent processes and tight version control. 


Compliance

Esko’s validated, digital WebCenter solution enables you to efficiently maintain compliance with both internal policies and Health Authority regulations, following GAMP5 guidelines for validation of automated systems.

Esko Solutions for Minimizing Risk

WebCenter Content Management

A single source that helps you manage the process of creating, updating, and approving content like text and symbols for packaging and leaflets. Reuse content across a broad range of regulations and requirements quickly, efficiently, and cost-effectively.

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WebCenter Content Management

WebCenter Artwork & Labeling Management

WebCenter Artwork & Labeling Management

A collaborative digital tool for you to manage the process of creating and updating artwork, labels and IFUs. Enhance visibility, create and update artwork, and approve or reject content to effectively mitigate risk.

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MediaBeacon Digital Asset Management

A software solution allowing for the creation, storage, locating, and distribution of digital assets for pharmaceutical products.

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MediaBeacon

Esko Solutions for Minimizing Risk

WebCenter Artwork & Labeling Management

A collaborative digital tool for you to manage the process of creating and updating artwork, labels and IFUs. Enhance visibility, create and update artwork, and approve or reject content to effectively mitigate risk.

Learn More

WebCenter Content Management

WebCenter Content Management

A single source that helps you manage the process of creating, updating, and approving content like text and symbols for packaging and leaflets. Reuse content across a broad range of regulations and requirements quickly, efficiently, and cost-effectively.

Learn More

MediaBeacon

MediaBeacon Digital Asset Management

A software solution allowing for the creation, storage, locating, and distribution of digital assets for pharmaceutical products.

Learn More

Stories from Pharma Companies​

About Esko

Esko provides quality solutions for Pharma because Esko understands the challenges imposed on the Life Sciences industry. Working alongside top Pharma companies, Esko has developed a deep appreciation for the constraints and demands of the regulatory process and the need for Pharma companies to get it right the first time, every time.

Resources for Pharma Companies