Compliance Integration in Product Development

Customer:

Leading European pharmaceutical companies

Challenge:

The customers encountered regulatory challenges stemming from siloed data access, change management, manual processes, and human factors.

Solution:

To address these challenges, Zircoo developed the SAP Batch Release Hub (BRH) solution. This solution offers data-driven batch release decisions and streamlines processes to ensure compliance with life sciences regulations efficiently.

Background:

The challenges faced by our customers included:

• Cumbersome manual identification process for impacted materials.
• Error-prone manual processes for adding changes to batches or updating batches after regulatory approval.
• Need to create new materials and associated master data for each change.
• Inaccessibility of regulatory dates for planners and the manual process of checking multiple systems for regulatory dates.
• Difficulty in tracking changes and aligning them with regulatory submission versions.
• Lack of visibility of regulatory dates in logistics processes.