This Major Pharmaceutical Company makes medicines for a number of ailments, from stuffy noses and asthma to hypertension and arthritis. The pharmaceutical giant’s top prescription drugs include asthma medication, anti-inflammatory drugs, hypertension fighters and cholesterol combatants. They are ranked in the Top 5 in The World’s Top 50 Pharmaceutical Companies.

The Client Needed To…

  • Validate a Corrective Action Preventative Action (CAPA) application that was part of a Regulatory Audit requirement
  • Develop Vendor Requirements and RFP (Request for Pricing)
  • Write and Review all Validation Documentation
  • Write and Review Standard Operating Procedures for system release

JDS lead a team of Technical Writers, Validation Specialists, and created a Quality Unit. By working closely with the Vendors and End User group we selected a Software Application and created a Validation Team.

Our Report Card for deliverables:

  • The Company was able to obtain the best value software for the best price based on a solid set of requirements
  • The Company was able to Validate the application within the timelines and budget set for the project
  • Regulatory Requirements were satisfied and the CAPA system was up and running for the Regulatory audit