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quality management system

 

The business environment that calls for companies to constantly improve their performance in order to be successful on the global market is driving the need for real-time visibility and control over business processes.

 

In order to reduce costs, improve quality, reduce cycle times or boost customer and shareholder confidence, organizations are implementing quality management methodologies such as ISO 9000 or Six Sigma in addition to regulatory requirements like cGMP.

 

Maintaining a paper based quality management system with disparate systems to control different processes in different parts of the enterprise has proved to be a costly and inefficient practice. As a result, people are looking to deploy enterprise systems that integrate and connect processes and turn traditional document hunting into a well managed and transparent electronic quality management system.

 

 

QAvalid QMS™ is a Web based system that manages and controls quality system documentation processes across multiple sites. Conforming to requirements from quality system regulations (21 CFR Part 820) or standards (ISO 9001) is facilitated by replacing paper and manual methods with a fully electronic, automated environment.

 

Document control, change management, equipment inventory, CAPA, audits and other quality system processes are integrated under a central interface. At the heart of the system, Linksense™ technology allows users to capture essential knowledge, drastically reducing the time to manage documents. Using the web interface and Microsoft® Office, quality professionals can work in a simple manner while the system ensures documents remain consistent and compliant, yet efficient to manage.

 

QAvalid QMS™ users can focus on the crucial tasks while the system automates recurring compliance and documentation activities. Configurable document review schedules, automated workflows and electronic signatures are supported by automatic audit trail records to eliminate the need to physically transfer documents and sustain compliance. Instead of manually recreating information each time a document is written, QAvalid QMS™ enables advanced reuse through master documents, document and project templates or automatically created and linked documents.

 

Complete control and real time information about the progress within each document provide managers with the ability to promptly fix problems and reallocate resources to improve efficiency.

 

The system enables managers to standardize documentation processes, ensuring that all the needed information is captured correctly and in the adequate format. This reduces the risk of errors or non-compliance and makes information easier to manage.

 

QAvalid QMS ™ is part of the QAvalid™ suite designed to manage and automate quality and compliance processes. QAvalid™ integrates and connects quality processes, providing a single, Web based platform which allows users to create, control and track information and still work in a simple and flexible manner.

 

In regulated industries, the QMS solution can be integrated seamlessly with the validation or facility commissioning and qualification modules. It also provides one framework for any company to use QAvalid EMS™ as combined quality and environmental management system.



QAvalid QMS benefits:

 

 

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