Laboratories third parties carrying out tests for the Pharmaceutical Industry, must demonstrate to their Client to be completely in accordance with the Regulatory regime that the same customer shall comply.
The checks on the validation activities (of methods, logical calculation, the software used), are more stringent and Reference Regulations are also those typical of Pharmaceutical ambit: 21 CFR Part 11, EU Annex 11, ..
In this case, the LIMS “Validation Kit” is crucial because it allows you to efficiently and professionally demonstrate the required compliance.
Among other offered media, the Validation Kit provides the correlation matrix among the User Requirements Regulators and functionality of the Software.
In the event that the Laboratory also deals with Product Certification, is important to manage the automation.