Merck Serono: Artwork for big pharma, taking the headaches out of the process

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 40,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. Merck is the oldest pharmaceutical and chemical company in the world.

Merck was using three different solutions to manage the artwork packaging process: 1000+ new instances and 500+ modifications per year. Each solution had its own workflows, its own documents, its own IT tools and was dedicated to one packaging development group. This configuration limited information sharing between teams and led to productivity loss.
Merck decided to review and harmonise this situation by selecting a single artwork management solution with one common artwork process shared by all actors worldwide: artwork development groups, packaging sites and affiliates.

Challenges

Comply with GMP standards and 21 CFR Part 11: controlled access, electronic signature and audit trail.
Monitor artwork design changes to facilitate planning management, minimize obsolete stock destruction and improve collaboration among distributed teams.
Improve business process efficiency by simplifying and automating clerical activities.
Allow automatic comparison between artwork versions.

Our solution
Process Automation

We proposed a solution based on the Documentum D2 product for the new harmonised artwork management platform. D2 is specially designed for companies subject to strict regulatory limitations or quality procedures, such as those found in the pharmaceutical industry. The solution was implemented using an iterative approach by adding functionalities and perfecting a working prototype based on Merck’s specifications. This prototype evolved into the final delivery by integrating the feedback provided by the business users on previous iterations.
Most of the solution was built without any development, using the powerful configuration interface of D2. Only one dedicated plugin was created to interact with the artwork comparison product “Content Compare”.

In parallel to the solution configuration, we built a dedicated migration tool to import artwork that had been produced and was being stored in three different solutions to a new and unified Documentum repository.

Benefits

IMPROVED BUSINESS PROCESS EFFICIENCY

With centrally-managed electronic documents replacing paper, spreadsheets and e-mail attachments, the efficiency of business process improved. Time-consuming clerical activities were standardised and, in some cases, eliminated by using a workflow engine.

REDUCED APPLICATION MAINTENANCE

Now, one application fits the needs of the three European packaging development groups. This single solution is centrally maintained and is accessible to all process actors worldwide.

EXTENSIBLE SOLUTION

We built a complete solution using the configuration interface of D2 with limited specific development and designed the artwork process templates with the Documentum Workflow Manager tool. These strategic architectural choices simplify solution evolution.

IMPROVED SECURITY

With a unique storage place for electronic documents, we defined a single security policy to secure document access. Only relevant contributors have specific access and rights to files according to their profile, the stage in the process and the document status.

PROCESS VISIBILITY

D2 comes with out-of-the-box document monitoring features, users can follow the progress of the process flow and automatic notifications are sent to relevant process actors on completion of a step.

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