Situation

  • In 2014, the FDA recalled 1 647 drug products and issued 100 warning letters to pharma companies.
  • The FDA’s inspections are increasing (+15% in 2015).
  • The average estimated cost of failing an audit is $480 000.

Challenges

46% of FDA observations are related to written procedures…

  • Do we have them?
  • Are they adequate?
  • Are they being followed?
  • Are we in control?

Success

An ideal solution provides…

  • ALL methods, equipment and SOPs documented.
  • Easy access & clear instructions for analysts.
  • A checked & verified documents and equipment database, including usage monitoring.

Solution

A centralized document database with individual analyst and equipment tracking, and with full documents/usage audit trail.

Anders Jernberg
Anders JernbergKey Account Manager
Tel: +46 (0)706 67 69 03

Ensure instruments and equipment are fit for purpose. Equipment records are managed within the solution, ensuring all information is up to date.

Centralized document database with individual analyst and equipment tracking and with full documents/usage audit trail.

Be confident that analysts have the required training to carry out tasks.