ECM Usage Patterns in Life Sciences

By Richard Medina posted 06-18-2013 21:09

  
Different industries have their own typical set of ECM “usage patterns” for ECM. This post outlines the most common and important ECM usage patterns in life sciences companies. It also applies to pharma, biotech, and similar regulated research, development, and manufacturing companies.
 
Ad Hoc (one-to-one, interpersonal, collaborative).  
Interpersonal information sharing is the primary characteristic of this usage pattern: either one-on-one or in small, collaborative groups of known users, typically within a department or work team. In this usage pattern, users create unstructured content, typically without templates or final work product structure in mind. In many cases, the content highlights portions of an opinion, finding, or recommendation, often with links or reference to “known” content and data providing the appropriate context. The content, even in its most ad hoc form, likely relates to a particular drug compound or project. For searching, most users (in a very small community) would consider this content “known.” Outside of that community, the content would most assuredly be regarded as “unknown.”
 
Work Product.
This usage pattern involves the creation of final (often departmental) work products that are the main deliverables of a group. This pattern is historically the most heavily managed; it is relatively straightforward for users to leverage templates and common styles when creating content in this scenario, but that does not mean the processes are always followed. The work product content often relates to a particular drug compound or project, and the content’s metadata must be managed with the content in order to enable searching and retrieval once the work product is made available to others. In many cases, users are challenged to provide all the metadata that might someday be needed to aid in someone else’s retrieval, yet not wanting to spend much time on adding the metadata or content to the repository in the first place. For searching, there is a combination of both “known” and “unknown” documents in this set. A major challenge lies in migrating content created in ad hoc mode and elevating its “value potential” (content + metadata + content relationships) to “work product” form.

Regulatory. 
This pattern involves content interactions around key work product (content) classified as submission content that is destined for the regulators in the US, EU, Japan, and other countries. While created with the regulations in mind, this content must be easily accessible inside the organization so that your company can answer questions about it quickly and easily. In addition, the metadata typically must provide a reference back to the original work product, supporting a “where-used” concept to aid in retrievals.

Enterprise (Procedural/Operational).
This usage pattern involves the creation of procedural and operational content, such as SOPs. While the content may be departmentally focused, the content authoring, review, and publishing process should be very similar throughout the enterprise (involving similar steps for authoring, departmental review, QA review, approval, implementation, etc.). Generally, the process steps are not particularly complex, but the overall process is heavily controlled, and changes to the process are thoroughly documented (and often prove compliance with GxP). For searching purposes, most users would consider these documents and their content as “known” documents.
 
External. 
This pattern manages content that has value to partners and to potential and existing customers, including the general public. This content includes presentation and web site (extranet and public internet) content. While created with the external customer in mind, this content must be easily accessible inside the organization so that your company can answer questions about it quickly and easily. In addition, the metadata typically must provide a reference back to the original work product, supporting a “where-used” concept to aid in retrievals.
 


#lifesciences #biotech #pharma
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