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Implementing electronic batch records for a new production area

Implementing electronic batch records for a new production area

The company is the largest pharmaceutical company in Japan and a leader in the global industry that operates more than 70 countries worldwide. It is ranked 12th by global Rx sales, 14th in the BRIC countries and 18th in Europe. In 2017, the company had net sales over 16 billion USD.

Customer need/ Project scope ​

PI-sheets and electronic batch records (EBR) had already been implemented in some areas of the plant. Production operators wanted to make the PI-sheet and EBR functionality available for a new product as well. The main objective of the project was to develop and implement a new PI-sheet and EBR that combined two processing steps into one PI-sheet, based on the existing PI-sheet elements already available.

Brief description of Akselera’s role, deliverables and results ​

Akselera performed the solution architect/PP-PI expert roles in the project, which was delivered together with TechWeaver. The processes covered by the deliverable were the weighing of raw materials and mixing of the semi-finished material​, full electronic batch record for these production steps​, and production reporting​.

Furthermore, this project was part of the company’s overall digitalization initiative. Some of the key business benefits achieved were:

Lead time reduction through parallelization.
The quality department could start the review of the first PI-sheet immediately after it is finished and before the QC results were available.
The deviation processing functionality highlighted all deviations in PI-sheets or inspection lots in a separate section of the EBR. For example, validation error in PI-sheet that weighing scale 2 was used, but scale 3 should have been used.
Inspection result outside the limits.​
Less risk of losing paperwork, which would lead to time-consuming deviation processing.​
Reduced man-hours when using system-supported validations of data entry because it was no longer necessary to have one person for data entry and another for control.​

Service Areas

«Until now we have produced batch documentation of approximately 150–200 pages per day in this production area that we now do not have to create, print, fill-in, control, and re-control. We are saving approx. 33,000 pages per year or approx. 165 kg of paper.»

Production supervisor

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