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 will help to…
- Eliminate the “arts and crafts” of cutting electronic records and pasting them into a paper lab notebook.
- Guide scientists through complex, labor-intensive or infrequent activities using a step-wise approach.
- Guide technicians through activities to ensure SOPs are followed.
Reduce human error using integrated “remote” instrument interfacing.
Solution
A procedural electronic lab notebook to enable structured lab execution with individual analyst tracking and full documents/usage audit trail.
Tel: +46 (0)706 67 69 03
Lab Execution System – Carry out processes in a controlled environment.
Lab execution – Break down each SOP into steps that lead users through the process. An SOP can result in many different lab methods.
Reporting – Regenerate the paper SOP from the configured lab methods, including any execution outcomes.
Workflow and methods – Transform your paper/digital SOPs into electronic methods for process execution.
