How do you manage the lifecycle of regulated applications or projects without tedious and time-consuming paper- and pencil-based validation?

The traditional paper-based processes are often costly, inefficient, and labour intensive to administer.

The Pharma workflow & eSignature solution with Application Lifecycle Management (ALM) delivers a paperless, yet fully traceable and auditable process where Requirements, Tests and Defects will be electronically signed post every human interaction, rejection, or approval.

During this event we will discuss the case of Xellia Pharmaceuticals who improved application quality and reduced application testing time by 30-40%.

  • Eliminate the need for time consuming PDF documents
  • Reduce days to minutes when you lock a test case and route them to those who needs to sign off
  • Re-use Test Case for next release or as the foundation for another test case
  • Easily track your progress with out-of-the box reports like Test progress reports or test traceability matrix
  • Remove the need for archive rooms and archiving of documentation - Everything is stored electronically
  • All information at your fingertips - a repository for all test related issues (ready for any audit by FDA or EMA)

Agenda:

  • 09.45 - 10.00  Arrival and registration. We welcome you with chef’s healthy snacks
  • 10.00 - 10.30  Introduction to Micro Focus & Miracle42
  • 10.30 - 11.30  Xellia Pharmaceuticals –speakers  Per Biscehoff Kristiansen & Therese Schønemann Blom
  • 11.30 - 12.00 "How can we start?"
  • 12.00 - 12.30 Round table discussion
  • 12.30 - 13.00  Chefs delicious lunch
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