Case Study: Pharmaceutical

 

 

Client: Pharmaceutical Company

Based in Asia

Background

A large global pharmaceutical company was looking to move to a paperless calibration solution to save time and reduce costs. The company faced challenges managing assets, ensuring consistent standard calibration procedures were reliably followed, and maintaining thousands of records on paper.

Objectives

The company needed to transition from a paper-based system – one that consisted of spreadsheets and results all recorded manually – to a user-friendly paperless system. The company sought a way to migrate all its historical calibration records into a new system to stay compliant in the event of an FDA audit.

The three main objectives for this pharmaceutical company were:

1) Have all instruments (assets) in one place to most effectively manage them

2) Set standard procedures for how one calibrates – having it on the instrument record and easily accessible for the technician to follow.

3) Facilitate paperless calibration – meaning the whole process does not use paper (important for signatures as well, with info on who signed off, exactly when, etc.).

 

    Solution

    The company decided to use ProCal for its paperless calibrations. ProCal ensured that every instrument was monitored and maintained at the site via a cost-effective solution. The company was impressed with ProCal’s overall functionality, its integration with SAP, the connectivity with documenting process calibrators, and Prime Technologies’ software validation services. The client also took note of the technical expertise demonstrated by the Prime Technologies team, and took advantage of both the training and customized reporting provided by Prime.

    Results

    ProCal enabled this pharmaceutical company to manage most of its calibrations in-house and reduce outsourcing costs. The client was so pleased that ProCal met all of their objectives and sales support that they recently increased their 50-user license to a 70-user license. The smooth transition and upgrades with ProCal helped this client company increase overall efficiency, and have provided cost-effective solutions for the company.

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