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Pharmaceutical Industry Efficiencies With OpenText CSP-Based Custom ECM Installations

Pharmaceutical Industry Efficiencies With OpenText CSP-Based Custom ECM Installations

Executive Summary

A global pharmaceutical distributor needed to optimize its document management processes by making it paperless and innovative. The company implemented a solution based on OpenText CSP and automated the main business processes.

Customer Business Challenges

In an effort to make its business more efficient and effective, a global pharmaceutical distributor recognized the need to install an enterprise content management (ECM) system. Other aims included optimizing internal processes and reducing document processing times, which had been slowed by the requirement for manual or handwritten data entry. This would enable the company to improve the quality of reporting, reduce the decision-making time, and increase the company’s overall efficiency. And by introducing an ECM system into its organization, the company also hoped to better meet government regulations, industry requirements (such as Good Manufacturing Practice Standards, GMP, and 21 CFR Part 11), and requirements of partner organizations.

TerraLink's Contribution

TerraLink successfully implemented and deployed the OpenText Content Suite Platform (CSP) within the specified timeframe. CSP’s basic functionality allowed the legal and PV (pharma vigilance) departments to automate important processes such as accounting for suppliers and partners; evaluation of suppliers and manufacturers for pharmaceuticals, devices, and technologies; and equipment management. The prime advantage of the solution included improving change management procedures, standard operating procedures (SOP), and measures to prevent and correct deviations in accordance with audit results (CAPA). Implementation of the platform enabled the company to automate contract management business processes. In addition, the system helped with tasks such as forms, audit and audit planning, vendor variance management, and quality improvement measures.

The new solution had a big impact on generating the following reports: audit planning (for local and foreign suppliers), quality complaints, local suppliers list, and permit reports by users and by facilities. In addition, the solution allowed for the preparation of PV reports (pending cases, follow-up reports, reconciliation reports, active reminder reports), attribute history reports, legal agreement forms (NDA, partnership agreement, contract agreement, distribution agreement), and others.

Customer Business Outcomes

Implementation of the new system provided the company’s employees with instant access to all reports and the ability to generate different reports while preserving the accuracy of the data. The processing time was significantly reduced. The solution helped the quality department increase employee efficiency by 60%, saving up to several hundred working hours per employee. The new automated system allowed the PV department to complete more cases than had been previously possible.

The automated business processes helped the pharmaceutical distributor improve its job performance with its partners, suppliers, and customers.