This Major Pharmaceutical Company is recognized worldwide for the medicines they provide to patients, physicians and healthcare organizations. Their business develops and markets prescription drugs for important health needs. Their products are concentrated in specific major therapeutic areas. They are ranked in the top 10 in The World’s Top 50 Pharmaceutical Companies.

The Client Needed To…

  • Implement new applications for their Regulatory Affairs department
  • Develop User Requirements for validation of the End User process
  • Validate the applications according to Regulatory Requirements and Company Procedures
  • Merge the databases of the new systems with the already existing data
  • Ensure the data was Migrated correctly and Validate the integrity of the data
  • Create new Procedures (SOPs) for the newly acquired systems
  • Release the systems for production use within the agreed upon timelines of the system owner
  • Accomplish this within the allotted budget

JDS created a team of Validation Specialists, System Testers and Quality Assurance personnel. By traveling to the Global User Group in Europe, developed User Requirements and User Acceptance Testing. Rode shotgun over the projects to ensure their success.

Our Report Card for deliverables:

  • The Company is now able to take advantage of new integrated technology and conduct business as usual
  • The Company has satisfied the regulatory requirements to validate the newly implemented applications
  • The Regulatory department has a new updated system – On time, Within Budget!