In the area of 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 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.

Controlling Documented Information

The ISO 9001:2015 standard 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. 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.

Document Management in the CAQ-System

The software QBD.Net allows you to create, maintain, control, and archive all your documents directly within your CAQ-System. It can be 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, QBD.Net includes sophisticated escalation management, project tracking, document access control, and facilitates a 100 % paper-free documentation.

Electronic Signatures and Biometric Access Control

Rules and regulations include the need for consistent access control, rights monitoring, traceability, and history management. Simple SSO authentication when starting the QBD.Net software is only the beginning. The biometric access control in QBD.Net, for instance, facilitates fulfilment of a variety of the aforementioned documentation rules and regulations. Same applies for 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.

Industry-Specific Requirements

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. These can be found in chapters 4.2.4 “Control of Documents” and 4.2.5 “Control of Records” of ISO 13485. The regulations of the US-American FDA also apply in this environment. In Section 820.40 “Document Controls” of FDA Title 21 Part 820 “Quality System Regulation”, the FDA requires very similar measures and underlines its requirements with the use of its feared “Warning Letters”.

Gateway to Successful Business Conduct

Document management, however, is about much than merely fulfilling the requirements of standards and regulations. It is also about structuring and controlling company processes and production workflows. Suitable documentation and the transparent visualization of processes, responsibilities, targets, and risks directly assist companies on their way to successful business conduct.

The combination of QBD.Net and the process management module Process.Net, for instance, puts a variety of powerful process visualization functions at your disposal. Applying Process.Net and QBD.Net in tandem also allows you to set the tracks for efficient and effective product documentation right from the product development process onwards. With these functions at your disposal, said documentation can then be consistently maintained throughout the entire product lifecycle. Using QBD.Net means that you can always provide sound and verifiable information with respect to your entire product history.

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