Vivaldi Software will be discussing Vivaldi QMS, a platform which has been developed to meet the precise and complex requirements associated with numerous quality standards, including ISO 13485, FDA and GxP for medical devices.
The platform includes a suite of tailored programs designed to make co-ordinating and controlling documents, processes and training records even easier.
Documents such as work instructions, SOPs and templates can be securely managed and controlled, according to the group.
Vivaldi Document Control offers management of versioning, archiving, flexible assessment and review processes, easy automatic distribution, permission management and access control, as well as document protection.
Also from Vivaldi is Process2Flow, a solution for risk management, audits, CAPAs, deviations, medical device master record and incident management.
Vivaldi QMS offers management of process records, with automation and a 360-degree overview, and Process2Flow allows users to view all registrations associated with their medical devices.
In addition, Vivaldi Training Manager enables the collective management of training courses, qualifications, employee training records-competences and targets.
Users can also evidence the skills against performing a task or job role, according to Vivaldi Software.
Vivaldi QMS is 100% compliant with quality standards and has been implemented already for ISO13485, FDA (21 CFR Part 11), GMP, ISO 9001, ISO 14001, ISO 17025, ISO 22000, OHSAS 18000, IFS and BRC.
The group explained that the software is useful in helping medical device manufacturers to alleviate concerns about validation.
As part of the ISO13485 QMS package, Vivaldi says it will facilitate the validation of Vivaldi Quality Management System. The options for this include self-validation, where the group can provide customers with the script templates for performing the validation themselves, or third party validation, where customers may have a validation partner or wish to use a Vivaldi Software validation partner who will validate the system against the specific requirements.
The implementation of Vivaldi QMS for ISO13485 certification “reduces the headaches and distractions that a typical QMS implementation can bring”, according to the group. A Vivaldi Business Consultant reportedly oversees all aspects from pre-sale specifications through to implementation and training. This, Vivaldi claims, ensures a smooth transition from manual to digital QMS or the early beginnings of a QMS system.
