Cato Software Solutions has been certified by TÜV SÜD for conformity of cato® and catoPAN® with GMP, GAMP and CFR21 Part 11
By means of "GMP Compliance Certification", the German TÜV SÜD has certified Cato Software Solutions that cato® and catoPAN® complies with the principles of GMP, GAMP and CFR21 Part 11, and that these software products are therefore suitable for the use in a validated environment of GMP-preparation sites.
The regulatory requirements for manufacturers of chemo-therapies, TPNs and similar medications are becoming more and more stringent. More and more pharmacies and compounding centers are obligated to validate their preparation systems according to the GMP- and GAMP-guidelines.
When using software such as cato® or catoPAN®, the system owner is not only obliged to prove that the quality assurance system of the software manufacturer and the functionality of the software meet the requirements of GMP and GAMP, but furthermore he must also prove the correct individual implementation of the software in his system (for example, by carrying out IQ, OQ, and PQ, together with all corresponding documentation).
Cato Software Solutions is the perfect partner for this. The functionality of our software and our QM-system do not only meet the requirements of the GAMP-guideline, but we also offer our clients extensive support by providing the required documents and services for the system validation.
These facts have been confirmed to Cato Software Solutions by the German TÜV SÜD within the framework of a "GMP-Compliance" certification with certificate no. 2213991, which is valid until August 2016.
During the certification process among others the following items have been checked by TÜV SÜD for compliance with GMP conformity:
• Company organization and QM System
• Employee qualifications
• Support organization and support implementation
• Software QS-structure, software documentation, change management
• Matching of software functionality with the requirements set forth in GMP, GAMP and CFR 21 Part 11
• Compliance with necessary data safety standards
• Documentation relevant to validation (such as, for example, risk analysis, qualification plans and validation plans,
IQ and OQ verification documents, etc.)
• GMP conformity of recommended hardware components.
If you have further questions, we are happy to inform you personally about all related issues. Please don't hesitate to contact us!