Transforming Standard Operating Procedures (SOP's) of Regulatory Affairs into Process Flows according to BPMN 2.0 Standard - SCALA Management Consulting

International
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.

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