Brands of all sizes rely on WebCenter
How WebCenter Works
WebCenter provides a central digital source for you to manage the process of creating and updating artwork, labels and IFUs. Enhance visibility by completing a brief that includes tasks, task assignments, information, and existing project materials. Once the updated artwork has been created, multiple reviewers can approve or reject the design from a single viewer until it meets requirements, effectively mitigating risk. Additionally, you have full version control to enhance traceability and compliance.
Say “hello” to WebCenter so you can say “goodbye” to the risk of errors and recalls, scattered processes, and confusing approval cycles.
A streamlined labeling and artwork process for the pharmaceutical industry
Scroll over each stop to follow the end-to-end labeling process
CCDS Update Request
- A formal change request is submitted to kick-off the labeling change process.
CCDS Authoring
- A content author will update the Company Core Data Sheet (CCDS) as a first step to capturing the required change.
CCDS Approval
- The CCDS approval process occurs prior to any changes to the labeling content that will be submitted to a HA.
Content Creation / Prep for Submission
- All content required for the HA submission will be created and approved. How this is executed across countries and regions may vary based on types of products (centralized, decentralized, national, mutually recognized) and lead country/reference country relationships.
Regional Update
- Different regions may have different HA requirements they must follow.
Localization
- Translations will be needed in many markets – in some cases multiple translations, along with other local changes needed to accommodate a local population.
HA Submission Ready
- Depending on a company’s roll-out strategy, HA submissions may be done in phases or in parallel.
HA Approval
- The HA submission & review process is a collaborative effort that may take weeks or years, depending on the change. Once this process is complete, the release of new labeling can occur.
Output to RIM
- The end-to-end labeling process encompasses an eco-system of technologies. An example of this is a Regulatory Information Management (RIM) system. Integration points may exist throughout the process for the exchange of data, content, or project status to create a streamlined process, removing the need for duplicate data entry and providing end-to-end visibility.
Labelling Change Notification
- Many events can trigger a labeling change, such as a safety, indication, storage, shelf-life, and even a corporate branding change. This notification will capture the type of change, along with details for the labeling team to begin the change process.
Impact Assessment
- Decisions will be made regarding what labeling needs to change, when it’s needed by, and which countries are impacted. A bundling/ unbundling assessment will also be completed (i.e., any impacted labeling currently in a change process and how should this new change impacts that activity).
Change Request
- A formal change request is submitted to kick-off the artwork process.
Artwork Mockup
- In many countries an artwork mockup is required with the Health Authority (HA) submission package. These mockups will include updates to content and layout as needed for the change and are mostly final.
Labeling Content Ready
- Once HA approval has been received, time is of the essence to hand off to supply chain for execution. The product packaging can be finalized for the print process.
Final Artwork Creation
- Artwork is being finalized, including any technical requirements for the print process. All regional versions are also being finalized at this stage or staggered based on required implementation dates.
Artwork Approval
- Any change to artwork requires an approval process. An initial approval may happen earlier in the process for content changes, but at this stage, a final approval may be needed before the print process begins.
Ready for Print
- All content and technical aspects of the artwork have been approved and it’s ready for the print process. Available inventory may factor into the timing of the print process.
Global Regulatory/Labeling
- 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.
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Global Artwork
- When it comes to Pharma, artwork is a lot more than a pretty picture. Pharma artwork is a serious business where the consequences for mistakes can be deadly. Artwork must not only be current and accurate, it must be easily shared and traceable.
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