Document control

Using the QM Suite for SOP management

The QM Suite enables the completely paper-free SOP management of standard operating instructions, starting with creation, continuing through approval and going all the way to publication. Developed specifically together with the Health Service, the QM Suite is a practical document control solution for laboratories, hospitals, clinics and research establishments.

Your contact partner

Alexander Reher
Product consultancy

+49 40 727360 329

a.reher(at)mediaform.de

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 in relation to process documentation with quality relevance. Working and procedure instructions are created easily and effectively with the aid of the QM Suite. Each QM document is created, checked, approved, trained and distributed. The QM Suite simultaneously guarantees that all employees have seamless access to currently valid documents. Changes, instructions and reasons for revision are managed at the same time, as are training courses for individual employees and different versions of the QM documents.

Document protection and monitoring

  • Read privileges for entitled users only (no access by unauthorised persons)
  • Write protection for all valid and archived documents
  • Every document has an "Audit Trail"
  • Timely notification before review periods expire
  • Notification function with definable escalation stages, including via E-mail
  • Guest function to audit the QM system

Taking note and training

  • Current up-to-date overview of taking note at any time
  • Integrated electronic signature (fulfils 21 CFR (Code of Federal Regulations) Part 11, GxP and the German Digital Signature Law)
  • Renders management of additional paper documentation superfluous
  • Availability of meaningful reports for inspection purposes with a few mouse clicks; all regulatory requirements are taken into account
  • Small expense for employee training

System

  • Web-based, location-independent working on a server system
  • No installation on workplace computers is needed
  • Compliance with the requirements and standards for medical quality management systems in accordance with DIN EN ISO 15189, DIN EN ISO 17025 and the Rili-BÄK (German Medical Association Guidelines)
  • Standardised interface design for easy orientation and requirement
  • Customer-specific interface design, with adoption of the respective company's corporate design for better identification with the software

Our customers