Deviation & Nonconformity
Manage change at every level across the organization and supply chain ecosystem to ensure quality and compliance requirements are met.
Out-of-the-box Ready, the Dot Compliance solution includes built-in business processes and forms to capture and manage deviations, nonconformities and any other type of “Quality Events”. Investigate, plan and implement actions in order to find the root cause of a deviation or nonconformity, ultimately preventing its recurrence, and enabling the generation of consistent quality events. Ensure detailed tracking of all deviations, including detailed investigation and assignment of one or more investigators.
Step by step approval and review process with electronic signatures
Action plan creation including dependencies
Integrated risk management and impact assessments
Integrated processes with CAPA, batch records information, related investigation and assessments
Business automation and integration with training and document management, along with other quality processes
" The product is user friendly. The flows in the system are the best practices that are used in the pharmaceutical industry (21 CFR Part 11, Annex 11, GAMP 5). Almost no adjustments (customizations) are needed. The validation package is very thorough and comprehensive. The software is stable almost without faults."
Computerized Systems Validation in Pharmaceutical
Good value for money
" The overall experience is good, the company uses the system as part of our routine and it has become part of our DNA. we get good support when needed, numerous aspects of the QMS are captured in one system - easiness of use - easy communication with other company employees "
Avoid lengthy design and configuration processes with our core QMS processes