Just an example of Martin Renke applying business analysis principles to a significant project for an East-coast-based global biopharmaceutical company.

1. M a r t i n R e n k eas an Agent of Change – Example 1 – Document ManagementProcess Re-Engineering (Business Analysis)

2. Client Size-up East-coast based biopharmaceutical firm >10,000 employees globally U.S. Regulatory Operations Department Martin retained to answer... “How can we best leverage electronic document management in our preparation for electronic submissions?” 2 Martin Renke as an Agent of Change >> Example 1: Document Management Process Re-Engineering

3. Project Approach 3 Martin Renke as an Agent of Change >> Example 1: Document Management Process Re-Engineering

4. Project Planning Objectives determination Mitigate inefficiencies Incomplete automation Heavy reliance on manual methods Difficulties in retrieval Duplication of information and effort Issues of reconciliation and disposition determination Existence of work-arounds Inefficient by their very nature Looking for optimization opportunities Martin Renke as an Agent of Change >> Example 1: Document Management Process Re-Engineering 4

5. Information Gathering Interviews of personnel Interviewees identified and informed Standard + tailored questions Interview notes completed and shared with interviewee to confirm understanding Process Map Q&A Job walk-throughs Questionnaire survey of personnel Martin Renke as an Agent of Change >> Example 1: Document Management Process Re-Engineering 5

6. Information Gathering Interviews of personnel Process Map Q&A Cumulative listing 129 questions addressed over 16 pages of content Job walk-throughs Questionnaire survey of personnel Martin Renke as an Agent of Change >> Example 1: Document Management Process Re-Engineering 6

7. Information Gathering Interviews of personnel Process Map Q&A Job walk-throughs Stepping through process stages as they occur Re-enactment + realtime Following the paper/ electronic record trail Identifying participants and paths Sourcing repositories Paper and electronic Formal and informal Questionnaire survey of personnel Martin Renke as an Agent of Change >> Example 1: Document Management Process Re-Engineering 7

8. Information Gathering Interviews of personnel Process Map Q&A Job walk-throughs Questionnaire survey of personnel Detailed 62 high-level questions Various survey questioning techniques employed Spanning 28 pages Martin Renke as an Agent of Change >> Example 1: Document Management Process Re-Engineering 8

9. Information Analysis Process mapping (as-is) Determined tabular approach best Permitted tracing of records for compliance purposes To-be process mapping not needed at this point Survey results compilation Identification of opportunities for optimization Martin Renke as an Agent of Change >> Example 1: Document Management Process Re-Engineering 9

10. Information Analysis Process mapping (as-is) Survey results compilation Responses consolidated into a single document 75 pages of content Anonymized for staff; named for project leader  MADE CLEAR TO ALL AT OUTSET Categorical statistics determined Analysis review annotations added Identification of opportunities for optimization Martin Renke as an Agent of Change >> Example 1: Document Management Process Re-Engineering 10

11. Information Analysis Process mapping (as-is) Survey results compilation Identification of opportunities for optimization Overall process evaluated over multiple process stages + general categories Each opportunity reflects an inefficiency of the process and an acceptance of related risk Relative risks categorized and each occurrence mapped relative to the associated process stage Clustering of risks evident Martin Renke as an Agent of Change >> Example 1: Document Management Process Re-Engineering 11

12. Information Reporting Recommendations Many occurrences distributed over numerous categories Categories mapped relative to process stages Can visually see clusters of ‘inefficiencies’ Overall report Presentations Martin Renke as an Agent of Change >> Example 1: Document Management Process Re-Engineering 12

13. Information Reporting Recommendations Overall report 97 pages of content + 60 pages of appendices Structured presentation of recommendations Targets for optimization identified and described in context Each mapped back to process map Associated risks identified and described in context Recommendations presented as a means to mitigate current risks to an acceptable level Associated presentations Martin Renke as an Agent of Change >> Example 1: Document Management Process Re-Engineering 13

14. Information Reporting Recommendations Overall report Associated presentations Interim presentation Keep departmental staff informed of progress to-date and further expectations of their time Final presentation Inform management of findings Performed once intradepartmentally Performed another time interdepartmentally Martin Renke as an Agent of Change >> Example 1: Document Management Process Re-Engineering 14

15. Potential for Extension Include a greater focus on metrics Be more explicit about critical success factors and supporting key performance indicators Provide recommendations in terms of potential savings (in addition to relative risk) Acknowledged though that additional time would have been required to do so Conduct surveys electronically Allows for easier completion Permits more rapid compilation of results Acknowledged though that an additional expense is involved Martin Renke as an Agent of Change >> Example 1: Document Management Process Re-Engineering 15