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LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2017 16 By S. Wollowitz AN OUTSOURCING CHALLENGE: CREATING A KNOWLEDGE BASE WITH LEGACY VALUE KNOWLEDGE MANAGEMENT Documentation helpful for the sponsor to provide such a checklist or the parties to agree on expectations upfront to mini- mize review cycles, close out reports more quickly, and reduce later requests for archived or unfindable results. Including specific expectations as part of contrac- tual agreements will allow the CDMO to make sure the proposals are adequately structured and that the data is being collected most effectively to create requisite reports. Of course the format may be proposed as well for editing by the sponsor. In either case, the internal reviewers at the CDMO can subsequently use such "documentation agreements" as their own review cri- teria for the most efficient closure. Knowledge management of non-GMP documenta- tion may not fall under the purview of the current data integrity discussions. However, good documentation practices in R&D; labs, combined with the translation of primary data into high-quality reports, will render the results and findings useful to all readers during the project and product life cycle and ensure legacy value to the knowledge database. L ▶ Can a person skilled in the art, but not familiar with the project, repeat the work based on this document and any referenced materials (that are also in the knowledge base)? ▶ Are the results sufficiently traceable to primary documents and data that can be used to support regulatory and quality positions? ▶ Are key conclusions fully supported by the evi- dence provided in the document (and if not, should they be key conclusions)? Still, documentation doesn't have to be complicated or take a lot of time. In some cases, CDMOs already have systematized their reports to a certain level, and introduction of a "context" page by the sponsor before completion or filing is all that is needed. In other cases, CDMO documentation practices may require an upgrade, but I have found that, in the long run, CDMOs end up happy they made the requested changes. Sometimes a simple checklist is helpful for the review process. For example, are the types of test equipment, raw materials, and excipients adequately defined? Is there CDMO-specific jargon that needs clarification? Are referenced documents also on file with the spon- sor? Is sufficient (and clear) raw data and spectra provided to allow the sponsor to reanalyze the results a year from now? As part of good communication, it is Document Users What The Information Is Used For What They Need To Get From The Document Primary readers worked with the technical expert(s) at the CDMO, i.e., knowledge creators, to carry out the activities. Typically, they are techni- cal experts themselves, though not always. ▶ Making decisions about next technical steps ▶ Making quality decisions ▶ Providing support for regulatory submissions They need results from the experiments, analy- sis, and evaluations to help them understand and document a preferred (or failed) process, formulation, method, model, etc., or to make a decision on steps forward. Secondary readers were not involved in the creation of the information, but they have some ability to pull knowl- edge history from others. ▶ Effectively becoming team members or taking over projects ▶ Understanding key decisions made previously ▶ Identification of missing knowledge that needs completion They need all of the above, plus context for what problems were being addressed and how the document fits into the overall library of informa- tion on the project, e.g., references to prior work, dates, etc. Tertiary readers review documents without contact with the authors or those that hold knowledge history. They are forensic readers, trying to find details or understand whole projects based on the documents available. ▶ Intellectual property ▶ Manufacturing change control support ▶ Due diligence for in-licensing or investing ▶ Reactivation of a dormant program ▶ Regulatory document support in multicycled programs They need all of the above, plus information on where the work was done, where to find original data, who did the work, and who may have reviewed or approved the reports. Information on alternate names or identifiers that may have been used across companies is useful when mapping out project histories and re-creating files. TABLE 1 SUE WOLLOWITZ is president of Wollowitz Associates, LLC.