Laboratory Specialists
Meet regulatory and customers' requirements on:
- Method validation ISO/IEC 17025, chapter 5.4.5 and ICH Q2(R1)
- Estimation of the uncertainty of test results (chapter 5.4.6 and Eurachem guidelines)
- Software validation (chapter 5.4.7.2, GAMP 5 and FDA guidelines)
- Record keeping track of equipment calibration, maintenance and qualification (5.5 and 5.6)
- Control charts assuring quality of test results (5.9)
- Participation in a suitable program of interlaboratory comparisons where possible.
The chart below shows a typical laboratory-activity flow, the items colored brown can be handled with the EffiValidation software:
