Document Management Software

When working with the Document Management Software QBD.Net, you don’t need to master any new type of editor in order to create and manage your documents – you work right in your familiar IT-environment and use exactly the same e.g. MS Office programs you use today. The document control processes are managed via a simple, MS Explorer-oriented tree structure that you are familiar with from your day-to-day MS Windows. This all means that there is no need for extensive introductory trainings and you can work with your own tried and trusted tools right from the beginning on. All documents, Word files, Excel forms, or PowerPoint files can be transferred to your QBD.Net document environment at the click of a button and existing documents can be imported directly to the position in the workflow they are required at. You can also use existing templates as basis for your new documents.

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.

The Document Management Software QBD.Net allows you to simultaneously distribute two versions of a document in your system: one version that includes change mark-ups and one version in which the changes have already been implemented. When the document is published, the software automatically creates two PDF files and you can determine who should receive which version of the PDF file. This function means that you are always in command of two versions: one “chronology” document including all change mark-ups and one “clean” document where every change has been effected. If the document is revised, the software will once again create an “old” version of the document that includes mark-ups, changes and comments, and a “new” version that can be used for starting a fresh document, based on the changes previously implemented.

It often makes sense to make documents viewable and linkable beyond the system boundaries of document management. For this purpose, QBD.Net offers a variety of different export functions and interfaces (e.g. OpenAPI, csv, XML, ...) to meet any requirement and not to create a new ”island“. The system itself has powerful web applications at its disposal to integrate all employees and to support them effectively in the implementation of document-related processes.

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 BPM Software 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.

In conjunction with the Projects.Net Project Management Software, each document in the system can be allocated to a specific project phase or step. The document control functions in QBD.Net thereby ensure that only the most current, valid, and approved version of the document is available in the individual project. The same also applies for the e-learning functions in the Training Management Software Qualify.Net. The perfect interplay with the training, project, and process management modules provides employees with 24/7 access to relevant company knowledge which they can internalize via self-study and check their level of knowledge via a web-based interface. All of this serves as basis for creating a dynamic and continuous improvement process which benefits everyone from the individual employee to the overall company.

• Integration of OLE-objects
• Import of existing documents at the push of a button
• Specified QM-contents in the database are available as active document attributes
• Master data management (employees, cost centers, customers, articles, suppliers etc.)
• Person-specific editing, inspecting, and distributing of documents
• Integrated job matrix
• Filter and search functions
• Automatic overdue action monitoring and control via e-mail or intranet

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.

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 7.5.3.2.1 "Record Retention" or 7.5.3.2.2 "Engineering Specifications" of IATF 16949, chapter 2 "Quality and food safety management system" of IFS, or chapters 4.2.4 "Control of Documents" and 4.2.5 "Control of Records" of ISO 13485, which is the leading standard in the medical technology sector. 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".