White Paper: The Case for a Knowledge Process Suite

Abstract

The forces of globalization, technology, and economic liberalization are combining to make life harder than ever for established companies. Only the Knowledge Intensive companies will survive under these extreme competitive conditions.

The biggest change taking place in the IT industry is going up the value chain by developing KNOWLEDGE PROCESS. Princeton Center has been at the leading edge of this development by working with different industries for the past two decades defining and developing tools for the Knowledge Process.

The ExpressTrain Knowledge Process Suite is helping industries with this problem by developing a simple but elegant solution using Microsoft Office using Word, Access, PowerPoint and Internet Explorer.

The Need: In the last few years, compliance expectations for regulated industries have risen dramatically. These compliance regulations have been driven by US Government Agencies, like the FDA, as a response to the need for higher quality and product safety. Many companies have responded by adopting best practices in the form of Standard Operating Procedures (SOP’s), implementing current Good Manufacturing Practices (cGMP’s) and assuring quality compliance via enterprise Management Systems for Documents, Content, Training and Performance Support. The demand for KnowledgeBase Systems to support the transfer of information in consistent, concurrent and compliant formats is becoming the major challenge for regulated industries.  With the movement toward continuous improvement manufacturing processes, Knowledge Process strategies may become the most significant contribution to corporate success globally.

The Current Environment: Despite the drive to improve Knowledge Process, many organizations continue to rely on paper forms, manuals, and specifications—especially those that have been used for many years and have been approved by the regulating agency. Many companies have moved to implement on-demand information systems and web-based reference repositories. However, in the more regulated industries, such as the Pharmaceutical Industry, the very environment of a regulated “Batch-Oriented” process control system is holding back the introduction and development of “Continuous Improvement” systems that make knowledge available on-demand. Clearly the movement for “Process Analytic Technologies” (PAT) is helping the Pharmaceutical Manufacturers to employ continuous improvement strategies so essential to increased quality.

The Next Step: The next step in the implementation of Knowledge Processes is to make the content capture, structure and access readily available on every desktop. Once the process of capturing core content related to best practices can become as easy as writing a memo or sending an email, then the organization will proliferate essential information about the best practices to all those who need it. The dream of providing the “right information, to the right person, at the right time, at the right level, in the right format” may become a common part of a high quality manufacturing system. The focus on Knowledge Process has driven the creation of a number of tools that support the efficient transfer of information across the enterprise. Major tools such as PeopleSoft, SAP, Distributed Control Systems (DCS’s), Document Management Systems, and Learning Management Systems have all evolved to address critical aspects of the overall need, and are just now getting to focus on product integration across an enterprise. The creation of a  Knowledge Process Suite is the latest step in the evolution of knowledge transfer systems.

An Example: The ExpressTrain Suite is one of the most versatile and powerful methods for capturing, structuring and re-purposing core content across the enterprise. Princeton Center’s Standard Operating Procedure (SOP) Software and Training Suite supports Standard Operating Procedures (SOP’s) with automatic generation of Training (Web-based and Workshop-based), Performance Support (job aids, performance checklists and detailed procedures), and References (SOP Reports, Task Qualification verification, flexible reports).

All inputs and outputs are made available via Microsoft Office using Word, Access, PowerPoint, and Internet Explorer. All Documents integrate with document management systems (like Documentum), and all web-based training modules are SCORM conformant to interface with Learning Management Systems (like Plateau).

Conclusion

A Knowledge Process Suite helps in a number of ways to provide on-demand knowledge transfer (from the knowledge producers to the knowledge consumers). Some of the major advantages and advancements included in this Knowledge Process are:

• Enforces Standards (SOP’s, cGMP’s)
• Rapid Development (saves time & resources)
• Automatically supports the FDA Validation process
• Provides Training, Support, & Reference
• Easy Maintenance (w/version control)
• Rapid Updates for New Requirements
• Language and Cultural Translations

The Knowledge Process will need to integrates with other management systems, including:

• Knowledge Management Systems,
• Document Management Systems,
• Content Management Systems, and
• Learning Management Systems

The ExpressTrain Knowledge Transformation Suite has been Validated for Pharmaceutical Industry Standards for FDA approval. Princeton Center successfully completed the rigorous PDA-ACC audit.

 For further information about the ExpressTrain Suite go to www.princetoncenter.com or send an email request for a demonstration to sales@princetoncenter.com.