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.

Anders Jernberg
Anders JernbergKey Account Manager
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.