Document control
Document control with the QM suite for standard-compliant Quality Management
The web-based QM Suite software allows fully paperless management of Standard Operating Procedures (SOPs) from creation, through approval and all the way to publication. With standard-compliant, tamper-proof document management, the highest requirements must be fulfilled. Work and process instructions are updated simply and effectively by using the QM Suite. Changes, notices and reasons for revision are managed at the same time, and so are the “seen” notes by all the staff, as well as various versions of the operating instructions. Specifically developed together with health service Quality Management Officers, the QM Suite is the practical document control solution for laboratories, hospitals, clinics and research establishments.
Secure, central communication
Maximum availability and secure access in the company's in-house Intranet. Simple, fast participation in the company's SOP process by all employees, without elaborate installations or additional licence costs.
Management of training by using Knowledge Control
The SOP training management system offers perfect support when distributing operating instructions and forms, and in documenting their contents. Reminder functions provide support when processing training requirements that are still outstanding.
Data coupling using LIS/LIMS
Data coupling using LIS/LIMS (Laboratory Information System/Laboratory Information Management System)
Developed for health service establishments, the QM Suite accepts information from the laboratory information system, thus enabling the simple, structured use of this master data when processing SOPs."
Document control in conformity with DIN EN ISO
SOP management in conformity with standards, through close collaboration with companies operating at a national and international level to fulfil requirements in the medical laboratory in accordance with Rili-BÄK (German Medical Association Guidelines), DIN EN ISO 15189 and DIN EN ISO 17025.
Easy display of tables - images - videos
Modern web editors allow the import of videos, images & graphics in many formats simply by drag-and-drop. It is also very easy to create complex tables - including frames and coloured shadings - and to enter formulae.
Simple installation without additional software
Easy to use as a server-based, platform-independent web application with access through any PC that has a web browser installed. Working with the QM Suite does not need the installation of additional chargeable software (MS Word, Excel) at every workstation.
Features of the QM Suite
The highest demands must be satisfied, especially for process documentation that is relevant to quality. Working and process instructions are created easily and effectively by using the QM-Suite.
Document protection and monitoring
Working and process instructions are created easily and effectively by using the electronic QM document control system. Each QM document is created, checked, approved, trained and issued for distribution. At the same time, the QM suite guarantees seamless access to the currently valid documents by all employees. In this respect, notes and reasons for revision are managed in exactly the same way as training sessions for individual employees and various different versions of the QM documents
QM acknowledgement and training
Tracking/tracing and documenting QM training sessions and acknowledgements in particular is a laborious undertaking when using an Office-based quality management system. With the QM electronic document control suite, all employees have central access to approved SOPs. Furthermore, the entire control of QM documents from creation and checking to release is structured via QM software. As a result, the time-consuming search for and provision of QM paper documents for audits or other evidence is no longer necessary.
SOP management QM suite
Specifically developed together with laboratories, the QM document control suite supports non-location-dependent working on a central server system. All employees can have cross-site access to the software. Access takes place via the Internet browser, simply and with minimal resources. An installation at every workplace is no longer necessary. Access to the QM software takes place through floating licenses. These enable versatile use of the QM software by users, while adapting to the company’s needs at the same time. Floating licenses enable many users within a company to share the use of a licensed product
- Read rights only for authorised users (no access for unauthorised persons)
- Write protection on all valid and archived documents
- Every document has an “audit trail”
- Timely notification before review deadlines expire
- Notification function with definable escalation stages, including via E-mail
- Guest function to audit the QM system
- Current overview of SOP acknowledgements at any time
- Integrated electronic signature (satisfies 21 CFR Part 11, GxP, Signature Law)
- Managing additional QM paper documentation becomes superfluous
- Availability of informative reports for inspection purposes and audits with only a few mouse clicks, all regulatory requirements are taken into consideration
- Low staff training expenses
- Web-based, non-location-dependent document control on one server system (Linux)
- Installation of software on workplace computers is unnecessary
- Compliance with specifications and standards for medical quality management systems in accordance with DIN EN ISO 15189, DIN EN ISO 17025 and RiliBÄK (German Medical Association Guidelines)
- Uniform standard interface design for easy orientation and operation
- Customer-specific interface design incorporating the corporate design of the respective companies for better identification with the software
What does SOP stand for?
SOP (Standard Operating Procedure) can be translated into German by the term Standard Working Instruction. A standardised procedure is indispensable in critical areas such as the pharmaceutical industry and in medical laboratories to safeguard the quality of the results in repetitive activities. The application of SOPs – created by the quality management (QM) – enables the provision of a high-quality service independent of time, place and personnel. As a condition of satisfying national accreditation agencies (e.g. DAkkS - German Accreditation Body GmbH), Standard Operating Procedures are given greater weight than work instructions.
The advantages of electronic document control lie in the guided creation of SOP documents comprising a title, version number, scope of application, approval date, validity date, and document release, together with the description of the work process and optionally supplements to the SOP. Controllable checking and release processes for an SOP, together with automatic versioning, minimise process throughput times for their creation. Using electronic document control software to revise, release and distribute Standard Operating Procedures contributes to reducing printed and obsolete versions on paper. Modern web-based document control systems enable paper-free access to relevant information from every workplace.
Using electronic document control to minimise process run times
Our customers, especially in medical laboratories, need to deal with numerous standard operating procedures and supplements based on laboratory methods and analyses. This involves creating, checking, modifying, distributing and archiving thousands of Standard Operating Procedures (SOPs). The QM electronic document control suite supports quality management staff in this task, and enables the digital management of QM documents. By using our QM software, you can electronically manage work and process instructions, test specifications, hygiene plans, forms, training sessions and other document types.
In this way, you significantly reduce the times for document creation, revision, checking and approval, and finally distribute them quite simply by a mouse click. Paper printouts are considerably reduced. Even document signature take place electronically –automatically receives an individual watermark, complies with 21 CFR Part 11, GxP and the signature law, and is exclusively software-based.
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