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GlaxoSmithKline Inc.
E-Lab
Automated Documentation System Earns Best-Practice Status for Pharmaceutical Company
Challenge
The Canadian division of GlaxoSmithKline (GSK), the global pharmaceutical company, employs more than 1,800 people. It is one of the top 15 contributors to Canadian R&D, investing almost $200 million annually. It is also one of Canada's top 10 corporate charitable donors. Canadian corporate headquarters is at the Mississauga, Ontario, plant.
Until recently, staff in the solid dose, liquids and topicals areas of the plant's quality control labs used an antiquated paper-based system to document their analyses and results. The only exception was the chromatographic analytical tests, which were managed by a data system called Atlas.
Almost all other data had to be written by hand and then manually keyed into GSK's quality module, called MERPS, an SAP product. About the only data that wasn't handwritten was that which emerged from instruments via printers, but the printouts were cut into strips and pasted into workbooks, and the data still had to be typed into MERPS.
The labs were not operating at peak efficiency because there were many transcription steps and manual hand-offs. The paper-based system required extensive archiving procedures and resulted in slow retrieval of information. Also, paper records can be prone to errors that are time-consuming to fix, including identification and correction of transcription and calculation errors, misfiling of analytical records and interpretation of handwriting.
Solution
Working in two teams, the QC staff all but eliminated paper in their workplace by creating E-Lab. It is actually two systems: a work-flow solution called SmartLab and a laboratory information management system, or LIMS. Both are linked to MERPS and Atlas, and (with the exception of raw materials testing, which still uses paper), all data now goes directly into E-Lab from the testing equipment or the testers' electronic tablets.
The elimination of paper was one of 10 goals that the teams set and met. The others were to:
- Increase efficiency by 18 per cent, which entailed automating most of the review process, building a calculation capability into the E-Lab worksheet and integrating method and results;
- Increase compliance by prompting the tester at each step of a procedure;
- Eliminate transcription and calculation errors;
- Ensure unambiguous identification of author and reviewer;
- Increase job satisfaction by eliminating routine calculations;
- Increase focus on results;
- Decrease costs of buying and storing paper;
- Enable the swift retrieval of results, in the event of an audit;
- Facilitate the trending of test results.
Results
The numerical results include an annual cost saving of $876,000; an 18-per-cent increase in lab efficiency; a 50-per-cent reduction in the time needed to review and approve analytical data and a 25-per-cent reduction in average sample cycle time.
The new system meets regulatory requirements for electronic records and signatures. Health Canada, which has auditing authority, has recognized it as a best practice.
Throughout E-Lab's planning and implementation, the two teams were in constant touch with quality control labs at GSK's other locations, and the Mississauga system was built to accommodate their requirements. As a result, all of the company's QC labs are now undergoing a similar transformation.
And, while 16 lab jobs were lost, the successful E-Lab implementation contributed to the Mississauga plant being awarded 22 new production mandates. To accommodate them, the facility is being expanded by 7,000 square feet and more than 150 permanent jobs are being created.
Innovative use of technology
The project teams were given one year to do the job. It was a complex application of technologies to the combined processes of R&D, data capture, data organization and documentation, and they did it in the allotted time.
Along the way, they devised such ancillary innovations as scripting macros that reduced the per-product testing method development time to two weeks from eight. The teams' entire effort was what one GSK executive lauded as "a tremendous display of technical mastery, innovative thinking and an intuitive take on change management."
A 2006 CIPA Winner!
For its exceptional application of information technology to solve real-world business problems, GlaxoSmithKline Inc. has been awarded a 2006 CIPA Silver Award of Excellence in the Organizational Transformation, For Profit category.
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