Laboratory Managers
The chart below shows a typical activity flow in the ISO 17025 laboratory. The items colored brown can be easily managed using the EffiValidation software:
The user can apply the software as follows:
- Book of Samples to manage samples, link them with specifications and trace results.
- Book of Documents to control documentation and training of personnel.
- Book of Equipment to ensure equipment calibration and maintenance.
- The Method Validation module to plan validation studies, collect data, assess results and document all this.
- The Uncertainties module to estimate and document uncertainties of test results.
- Book of Deviations to record non-conforming results and manage quality deviations.
- Other Electronic Laboratory Logbooks to ensure data integrity, security and the 21 CRF part 11 compliance.
With our software, the better laboratory efficiency is achieved by reducing the labor-intensive calculations, leveraging automation and by making the generation and retrival of quality documents easier. The software is simple and easy to use, enabling all lab assistants to operate it , has a natural standardization effect via unified reporting and give managers better control to see the work in progress and the work completed.
Cross reference table ordered according to the standard requirements in the ISO 17025:
| Module in EffiValidation 3.0 software | ISO 17025 requirements | GxP practices |
|---|---|---|
| Calibration | Chapter 5.4.1 | – |
| Method validation | Chapter 5.4.5 | ICH Q2(R1) |
| Uncertainties | Chapter 5.4.6 | – |
| Software validation | Chapter 5.4.7.2 | GAMP® 5 |
| Electronic Laboratory Logbooks | Chapter 5.5 and 5.6 | 21 CRF Part 11 |
| Control charts | Chapter 5.9 | – |
| Inter-laboratory comparison | Chapter 5.9.1 (5.6.1) | – |
