Document Archive & Submission Workflow at Merck-Serono

The customer

The Merck-Serono Corporate Regulatory Affairs department intended to replace the paper archival and submissions approval workflow with an electronic document archive.

Logica solution

• Logica had been selected to secure the required GxP standards and validate the new system.
• The solution supports the customer in achieving a higher degree in GxP compliance as well as increased software quality.

Customer benefits

• Online 24 x 7 hours access to the document archive
• Immediate response to regulatory authorities worldwide
• Management of the submission lifecycle