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    Pharmaceutical Company

Quality System Operations

appr. 30

Employees

Team SCALA

2

Consultants

Time Period

6

Months

Transforming Standard Operating Procedures (SOP’s) of Regulatory Affairs into Process Flows according to BPMN 2.0 Standard

Starting Point

  • Many different process modeling initiatives were carried out in the company, most of which were insufficiently with regard to the regulatory requirements; moreover, the SOP’s were described on different detail levels and were not very flexible in their use.
  • By converting the SOPs into process flows based on a common notation (e.g. BPMN 2.0), the level of detail should be made comparable and the use of the processes by the departments increased.

Approach

  • Analyzing and consolidating the SOP’s of Regulatory Affairs (more than 180 SOP’s).
  • Transferring the SOP contents and descriptions into a hierarchical process model in the process modeling tool Aeneis.
    • Modeling the process flows in compliance with the BPMN 2.0 notation.
    • Detailing process flows down to the reporting level relevant for audits (including mapping of additional process information such as roles, supporting tools and IT systems).
  • Introducing a further modeling level using a selected process (pilot process).
    • Describing processes on working level including assignment of additional process information (e.g. work instructions, manuals, training documents).
  • Conducting and moderating regular workshops with experts to coordinate results and optimize process flows.

Deliverables/Benefits

  • Uniform and standardized documentation (BPMN 2.0) of regulatory processes and requirements.
  • Documentation in a proven process modeling tool that supports evaluations with different views and thus for different recipients.

Further Project References

  • Developing a Process Model according to BPMN 2.0 Standard in Clinical Development22. March 2021 - 1:34
  • FT2E® (Analysis & Design) in the Corporate Communication Department (Interface: M&A/Corporate Finance)27. March 2021 - 10:59
  • Optimizing the Clinical Development Business Process Model and transfer to a web-based Solution20. March 2021 - 19:54
  • Managing a Program for the Implementation of an integrated Data Hub for Clinical Development21. March 2021 - 18:27
  • FT2E® (Analysis & Design) in the Regulatory Affairs Department of a French Subsidiary22. March 2021 - 1:14
  • Planning, managing and monitoring a Hardware and Software Roll-out for Fund Services & Private Banking22. March 2021 - 1:14

Our office in Cologne

SCALA Management Consulting GmbH & Co KG
EuroNova III
Zollstockgürtel 61
D-50969 Köln
n: +49 (0)221 / 27 64 59 82
x: +49 (0)221 / 27 64 59 83

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LAST PROJECTS

  • Developing a Process Model according to BPMN 2.0 Standard in Clinical Development22. March 2021 - 1:34
  • Developing a flexible and cross-functional Business Data Model in Clinical Operations20. March 2021 - 19:58
  • FT2E® (Analysis & Design) in the Corporate Communication Department (Interface: M&A/Corporate Finance)27. March 2021 - 10:59

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