Standard Operating Procedure Software Pharmaceutical Case Study
A Major Pharmaceutical Company
Client Problem:
Making new Pharmaceutical products is a major undertaking. At this pharamceutical company it is the responsibility of the Pharmaceutical Research Institute to create the manufacturing processes, develop the scale-up procedures, and specify the Standard Operating Procedures for new products being introduced.
Solution:
We introduced ExpressTrain Standard Operating Procedure Software to a major pharmaceutical company where we were able to help them capture core content relating to Pharmaceutical Operating Instructions and to create a single-source repository for all procedures, processes and related facts associated with manufacturing operations. ExpressTrain was also used to build a single-source knowledgebase for the DeltaV DCS.
By using ExpressTrain Standard Operating Procedure Software, the pharmaceutical 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. The area of Operating Instructions specification is particularly important, since this is where the rules for equipment operations are specified and where standard that are used in various manufacturing facilities, around the world, are originally determined and validated.
Financial Impact:
The ExpressTrain Standard Operating Procedure Software and Process was used to help subject matter experts specify the best set of operating instructions (OI's) for the initial product production as well as the roll-out to other larger scale facilities globally. ExpressTrain is now being expanded beyond the PRI/PRD organization. The pharmaceutical company has continued to use the ExpressTrain Standard Operating Procedure Software to standardize all of their new and revised work instructions and operating instructions. The pharmaceutical company needed to revise all of their work instructions for PRD/PRI within a twelve month period and without the ExpressTrain Standard Operating Procedure Software they never would have achieved this goal.
