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Standard Operating Procedure (SOP) Software for Pharmaceutical and Biotech Companies

How Princeton Center’s standard operating procedure (SOP) software helps pharmaceutical and biotech companies manage their SOP’s, increase compliance and improve Q/A, while reducing risk.

In the past few years, Princeton Center for Education Services, Inc., has introduced a useful set of standard operating procedures software and SOP training tools to help pharmaceutical and biotech companies better manage their standard operating procedures while increasing quality and reducing risk of citations.

Princeton Center has been working with several pharmaceutical companies in the area of manufacturing operations with a novel approach to supporting and training operators and supervisors in implementing Batch Sheets and other Operating Instructions. By introducing the standard operating procedure (SOP) and training software to manage the SOP’s involved in the manufacturing operations and implementation in clean room processes, the company was able to create a single-source for critical content which can be used to automatically generate support materials that are consistent, concurrent and compliant. The implementation of the standard operating procedure (SOP) software has lead to reduced notations and citation for operational errors, and has significantly reduced the cost of creating up-to-date training and support materials.

Following this success, Princeton Center introduced the standard operating procedure (SOP) software to a second pharmaceutical company  this, where they were able to help capture core content relating to Operating Instructions and create a single-source repository for all procedures, processes and related facts associated with manufacturing operations. The standard operating procedure (SOP) software was also employed to build a single-source knowledgebase for the Emerson DeltaV – Distributed Control System (DCS). By using our standard operating procedure (SOP) software, the company was able to create core knowledge objects that were reassembled in a number of appropriate ways to create training and support for team members, operators and supervisors, all from the same library at a dramatically reduced cost.

Additionally, Princeton Center has begun working with a biotech company to help manage application support and training. By using our standard operating procedure (SOP) software, the company is able to create a single-source describing critical application operations, and automatically generate the web-based training, user guides and on-line Help files for the professional staff, increasing performance and reducing risk of error.

During this time, Princeton Center has been working to have portions of the standard operating procedure (SOP) software implementation “Validated” for use in Plants. ExpressTrain has passed the exhaustive PDA Audit and Princeton Center has the necessary Validation Scripts to help and assist any pharmaceutical or biotech company to validate the software within their own operations.

If you are interested in more information about our standard operating procedure (SOP) software, please browse our website at www.princetoncenter.com or contact us at sales@princetoncenter.com

About the Author:

Peter J. Rizza, Jr., PhD. is the Founder of the Princeton Center for Education Services, and has spent his entire professional career working with learning strategies, knowledge transfer and authoring tools. As past president of the MidNJ Chapter of ASTD and speaker at the Society for Applied Learning Technology, Dr. Rizza shares his lessons learned in improving the paradigms for training across several industries.

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