A leading Biologics Company was able to see a 60% improvement of compliance of documentation, helping create a major revenue, cash flow and profit impact. A Process Management Discipline allowed for transparency of this improvement initiative and for related agile innovation.

    Organization Background

    A leading Biologics Company known for producing high quality products for various medical lifesaving applications has strict compliance requirements for the handling of those products and the related documentation. The company addresses those requirements in a manual way and strict quality controls of products and documentation; however, this approach was not sustainable due to the significant growth.

    Business Challenges and Opportunities

    Due to issues with the required compliance documentation, the shipment of many of the company’s items were significantly delayed. As consequence, there was an increased need for additional storage space which had a negative impact on cash flow and revenue. The company realized their compliance related business processes were inefficient and time consuming.

    The executives at the Biologics Company understood that by standardizing, digitalizing, and improving their compliance documentation related business processes, they could reduce errors and inefficiencies. Once this project was initiated, the organization realized they could substantially reduce their compliance issues. They decided to look for help to address these challenges and reached out to BPM-D to provide guidance and clear directions for improving their business processes.

    Identification of Improvement Opportunities

    Rapid As-is process analysis leveraging the SAP Signavio tool to identify what causes the compliance issues and define actionable improvement opportunities.

    Design of Innovative

    To-Be Processes To-be processes were defined in Signavio addressing in improvement opportunities. They show in detail how the document-related noncompliance can be significantly reduced.

    Value-Packages as Basis for Pragmatic Realization

    The required realization initiatives were defined in the form of “value-packages”, describing how the To-be processes were to be implemented. Core was the definition of a simple compliance application digital check lists and its focused use.

    Start of an Agile Innovation Approach

    A short term To-be process scenario was complemented with a medium-term scenario for further improvement leveraging a combination of workflow and document management systems. This started the ongoing innovation process.


    • Process Innovation resulted in reduction of over 60% in document-related compliance issues in less than 3 months.
    • Significant improvement of cash flows as well as strong impact on revenue.
    • Process governance structure in place the ensures an ongoing improvement and innovation.
    • Approach for agile process innovation defined that guides the process governance.
    • Generation of “Process Playbook” out of to-be mode to support change management, especially education about new process.
    • Update of Business Process Management Playbook to reflect applied approach and use of the SAP Signavio tools.

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