A highly integrated and interconnected quality management software. In qmsWrapper, Quality Management is integrated with Project Management, Document Management, Risk management and Team Messaging rather than implemented as a separate management layer – in other words, QMS is sewn into the very fabric of qmsWrapper. That maximizes productivity and provides a seamless team based compliance experience. Streamline the way you approach FDA 510k or ISO 13485 standards, without adding another layer of management, administration and bureaucracy to the daily work. Everything you need to organize, create and manage projects. qmsWrapper is perfect solution for startups, creative teams, growing organizations and quality oriented teams including medical device and App manufacturers, who need help to achieve regulatory and Standards compliance.
Whether FDA or ISO, Regulation or Standard, any QMS system (even if purchased “off-the-shelf” (OTS)), should be validated to perform as intended in their chosen application.
Validation Documentation is extensive and takes a serious amount of team time.
Documentation, information, testing results and other validation evidence should show the product meets its predetermined specifications and quality attributes and that it will perform as intended in their chosen application.
Software validation is a requirement of the Quality System regulation, Title 21 Code of Federal Regulations (CFR) Part 820, and 61 Federal Register (FR) 52602, respectively.
Validation requirements apply to software used in the implementation of the device manufacturer's quality system.
If the OTS software vendor can provide the information about their system requirements, software requirements, validation process, and the results of their validation, the medical device manufacturer can use that information as a beginning point for their required validation documentation, which can be useful in establishing that the software has been validated.
Specific requirements for validation of device software are found in 21 CFR §820.30(g).
4.1.6 The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such [QMS] software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.
The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software.
When you subscribe to an annual qmsWrapper license you get an up to date and full set of QMS compliance documentation so you can prove compliance for either FDA’s Validation for Intended Use or ISO’s Validation for Use.
This complete set of FDA and ISO compliance documentation represents an estimated 423 hours of your team’s valuable time saved, and this for each software update so your compliance requirements are always current.
- Product Requirements Documentation set
- Product Specification Documentation set
- Design Impact Change Analysis
- Traceability Matrices
- Validations Test Plans
- Verification Test Plans
- Installation & Operational Qualification Validation
- Validation Reports
- Verification Reports
- Validation Certificates
Note: Most of these are sets, consisting of multiple documents and 1000’s of pages.