This two-part article explores related tools and technologies that biopharmaceutical companies can leverage to build an efficient mechanism for capturing and delivering valuable information. In BioProcess International's December 2009 issue, part 1 of the series focused on infrastructure selection and how hardware, software, and information systems form a kind of ecosystem (1). Simplicity, sustainability, and scalability can be achieved only when that trio is designed holistically. Part 1 further explored structured data capture and analysis tools, whereas this second half is dedicated to unstructured data capture and analytics. Part 2 concludes by focusing on how an integrated environment can be created to leverage on both structured and unstructured data, providing a single access window to enterprise information for end users.

A GMP/GLP Environment

Currently the major portion (estimated >80%) of the knowledge space within a biopharmaceutical organization exists in unstructured form (free-form text and documents). This type of data lacks defined structure and schema (like the rows and columns of structured data) needed to make it easily interpretable by machines, so this is difficult to query and search. Unstructured data tools bring some level of structure and format to such highly unorganized information. At the same time, such tools provide an efficient and easy way to capture, share, and search through these data.

Before actually discussing unstructured data tools, it is important to understand the work processes that contribute toward most unstructured data and how they relate to one another. One such conglomerate of work processes is formed by the current good manufacturing practice (CGMP) and current good laboratory practice (CGLP) systems.

CGMP Systems: In the biopharmaceutical industry, much unstructured data comes from CGMP quality systems in which various work processes — such as corrective and preventive actions (CAPAs), nonconformance, training management, and standard operating procedure (SOP) revisions — involve creation of many documents. As Figure 1 shows, work processes within quality systems are linked to the central process of document management and control. They mainly involve task assignment, tracking, review, and approvals. So they require a good workflow engine that can route documents and issues through a well-defined cycle while capturing knowledge and events generated at each stage. There are two approaches to managing QA system work processes: prepackaged solutions and custom builds.

The first approach involves implementing a prepackaged quality management solution specifically designed for GMP requirements. These solutions cover every aspect of quality management, from document management to training and investigation. One major benefit of this approach is that prepackaged solutions provide a single interface and integrated work flow for all interconnected work processes, which helps in efficient closure of issues related to the quality management. High costs involved in this route can make it unsuitable for the small to medium-sized enterprises, however. Two major players in this field are Master Control, Inc. (www.mastercontrol.com) and Trackwise software from Sparta Systems (www.sparta-systems.com).

The second approach is to assemble the different building blocks of a CGMP quality system (Figure 1) using independent solutions and integrating them. Typically this can be accomplished with a good document management system, a good issue tracker system, and/or a good workflow engine. The document management system takes care of document control, and the issue tracker can be used for tracking activities related to CAPAs, nonconformance, and change controls. Integration is the major challenge in this approach. Many open-source alternatives are available in this field, however, which makes it a viable option for small and medium-sized enterprises. Alfresco (www.alfresco.com) and Knowledge Tree (www.knowledgetree.com) provide good solutions for document and content management. The Request Tracker program from Best Practical Solutions, LLC (http://bestpractical.com/rt) offers a good solution for issue tracking and workflow management. ProcessMaker (www.processmaker.com) and Jira software from Atlassian Pty Ltd. (www.atlassian.com/software/jira) are a couple of other issue-tracking workflow engines offered as open source and for commercial license, respectively.

CGLP Quality Systems: Similar to the CGMP environment for manufacturing are CGLP work processes in research and development that involve documented experiments in laboratory notebooks, technical memos, and reports. These can be managed similarly to CGMP systems. Both mainly revolve around the creation, control, and workflow of documentation. Unstructured data tools (explained below) can play a major role in making document creation (authoring) itself an efficient process capable enough of handling control and work flow in an integral process.