Pharmaceutical R&D Harmonization

imOne of the world’s largest pharmaceutical companies merged its decentralized pharmaceutical Research and Development (R&D) divisions in the United States, Japan and Europe into a single, centralized global organization. The objective was to increase operational efficiency and compete more effectively in the global market.

Challenges

pharma

In order to be successful, the company needed to harmonize existing Standard Operating Procedures (SOP’s) for all locations and eliminate inconsistencies in R&D global operations. To do so, they had to implement a quality system and create a policy document and related process documents for each quality system element.

Solution

Information Mapping’s experts assisted by

  • facilitating working sessions with subject matter experts for each integrated quality system element to define policies, processes and procedures.
  • developing a single global quality system that harmonizes policies, processes and procedures, with best practices defined and standards and model documents in place.
  • training and mentoring technical writers who used the Information Mapping skill set to develop and maintain the documentation.

Results

Information Mapping’s consultants and training professionals enabled this client to achieve 40% reduction in number of SOP’s $2.1mm annual reduction in SOP maintenance costs (change requests, verification, updating attributes, reviews and distribution), and $2.4mm annual savings in SOP-related training costs.

Information Mapping helped this client to successfully implement a new quality system and harmonize its SOP’s, increasing operational efficiency and enhancing the company’s ability to compete in the global pharmaceutical marketplace.