Document Management Software
Document management, document control, and document archiving in one software including SOPs, electronic signatures, and version management. Create, maintain, control, and archive all your documents with just one program. The document management software QBD.Net is fully embedded in your existing MS Office environment, allowing you to continue to work with the programs you are familiar with and use QBD.Net to control all document monitoring and maintenance processes. Amongst a host of other functions, the software includes sophisticated escalation management, rights management, electronic signatures, project tracking, and facilitates a 100% paper-free documentation.
Advantages of the Document Management Software
- Document processing in everyday office programs
- 100% paper-free documentation
- Process, element, and standard oriented
- Document control in accordance with ISO regulations
- FDA compliant (validated and qualified)
- Escalation Management for action and due-date tracking
- Integrated PDF creator
- Electronic signatures
- Parallel version management
- Automatic and uninterrupted revision management
- Archiving of historic document statuses
- Connection to training management
- Freely definable attributes
Functions of the Document Management Software
In areas such as quality management, it is almost impossible to meet the strict requirements of standards and guidelines regarding the handling of documents without holistic and fully integrated Document Management Software. Apart from guidelines regarding the document creation process, standards and specifications such as ISO 9001, IATF 16949, and ISO 13485 also contain detailed guidelines relating to the maintenance, control, and archiving of documents. Even from a relatively small company size onwards, these requirements quickly exceed the limits of manual document management and, not only due to risk and economic considerations, make the use of sophisticated software solutions virtually unavoidable. And this is where the solution QBD.Net comes into play –because software beats paper.
The document control functions allow you to define, in advance, how a document is to be distributed or published upon completion. This can be determined either document, project, workflow, or job specifically. Prior to completion of the document, you can already predefine who should be allowed to print, copy, or distribute the document. You can also make your documents available to a predefined group of recipients via the integrated internet/intranet reader. The freely definable workflow allows you to determine e.g. whether a document should always be opened automatically in the PDF viewer or a watermark should be included in the printout in order to verify process status or validity. All in all, QBD.Net includes those diverse, freely-configurable options that any holistic Document Control Software must contain in order to ensure the standard-compliant control of your documents.
Rules and regulations include the need for consistent access control, rights monitoring, traceability, and history management. Simple SSO authentication when starting the software is only the beginning. The biometric access control, for instance, facilitates fulfilment of a variety of the rules and regulations. Same applies to the optional multi-password-protected document access system and individually configurable rights concept, which allows company-wide control of individual documents or entire document and project structures. All of this is also necessary because the basic requirements of ISO 9001, to which other standards also refer, are joined by several industry-specific requirements: IATF 16949, ISO 22000 / IFS, ISO 13485 or 820.40 “Document Controls“ of FDA Title 21 Part 820 “Quality System Regulation“ are familiar examples.
Each CAQ.Net Module Puts the Following at Your Disposal
- Management of systemwide actions and tasks
- Definition of attributes for all relevant entities
- Configuration of role concepts and access rights
- Use of multilingual application & transaction data, incl. translation tool
- Application in multi-tenant mode for cross-location and cross-database scenarios
- Modification of module-specific content and interfaces
- Creation and modification of reports and e-mail templates
- Analysis and evaluation of systemwide data across all CAQ.Net applications
- Data validation via Audit Trail
- Automated data exchange with existing IT-systems and infrastructures
Standards-Compliance of the Document Management Software
- DIN EN ISO 9001 (e.g. Chapter 7.5)
- IATF 16949
- DIN EN ISO 13485
- DIN EN 9100
- DIN EN ISO/IEC 17025
- FDA 21 CFR Part 820.40
- FDA 21 CFR Part 11
- More Regulations »
Document Management Software FAQ
According to chapter 7.5.1 of ISO 9001:2015, an organizations quality management system shall contain not only the documented information required by ISO 9001, but also the information that the organization has determined to be necessary for the effectiveness of the QM system. The standard also contains numerous requirements regarding updating, control, and archiving of documents. When, for example, creating and updating documents, the organization must ensure that appropriate marking and formatting as well as appropriate review and approval with regard to suitability and appropriateness are ensured. This means ensuring that documented information is always available where it is needed and adequately protected.
- Distribution, access, retrieval, and use of documents
- Filing/storage and preservation, including preservation of legibility
- Monitoring changes (version control)
- Storage and future whereabouts
Due to the high significance of documented information and its handling in ISO 9001, document management almost logically becomes an elementary component of a modern CAQ system.