Laws, standards, customer requirements, the internal organization and all associated rules and specifications must be implemented, adhered to, and their fulfillment proven. RQM assists with these tasks in connection with the necessary actions, which must be defined and implemented. Standards are basic documents that describe the requirements in general terms.
With RQM, we help you implement these general requirements in concrete form. RQM has already been checked in many projects in the course of audits and FDA validations.
RQM supports the following standards, among others: ISO 9001, ISO/TS 16949, VDA volumes, FDA 21 CFR 11, ISO 13485, VDI 5600, and many more.
Examples of such tasks are:
- Validation: functions that support validation and agile release planning and development of RQM
- Access protection: User management, roles, rights, additional queries, etc.
- Audit trails: History in all modules as well as configurable audit trails
- Maintenance, protection, repeatability: Database, access, back-up, export
- Electronic signature: User ID, password, biometry, approval processes, etc.
- Document control: Operating/maintenance documentation, versioning, PDF/A, etc.