- 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.
46% of FDA observations are related to written procedures…
- Do we have them?
- Are they adequate?
- Are they being followed?
- Are we in control?
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.
A centralized document database with individual analyst and equipment tracking, and with full documents/usage audit trail.