Solution: Quality Management for Pharmaceuticals and Medicine

Quality management in the regulated industry with enaio®

All regulations and guidelines in view at all times

Qualitätsmanagementsysteme (QMS) gehören zu den wichtigsten Faktoren langfristigen Unternehmenserfolges.

Quality is the key word in production. Companies in all branches of industry have to define and guarantee the quality of their products and their actions for different reasons.

Laws, regulations, standards, official specifications and customer requirements clearly describe what needs to be observed. Companies describe the degree of quality and how it is created and controlled in a large number of documents. The management of these documents is a major challenge for those responsible.

enaio qms suite diagram
Quality management in the regulated industry with enaio® 
Overview of the variety of solutions within the QMS suite

Trust is good. A flexible ECM is better.

Sustainable quality management in the pharmaceutical industry

Quality management in the “regulated industry” is subject to special regulations. Drug safety, SOP management (controlled QM documents), customer complaint, change management, GxP and much more are closely monitored by the authorities. All production processes must be documented in a comprehensible manner (batch recording). All events related to the quality of the product must be recorded, analyzed and evaluated (incident management and change management). Deviations must be documented (deviation management) and errors eliminated and avoided in the long term (CAPA processes). If necessary, the effects must be reported to the authorities (vigilance).

Accelerate and automate processes

The goal of enaio® is to simplify the complex processes between people and information in the pharmaceutical and medical technology sector and to make them securely controllable. Our many years of experience with internal industry processes have led to best-practice solutions that are both validated and proven. They simultaneously ensure improved networking and automation of processes in administration, documentation and the provision of information. What’s more, information and documents are intelligently linked and can be created, managed, and delivered through electronic workflows – in any department, anywhere in the world.

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