The goal of quality management systems is to guide organizations towards improved performance while increasingly and consistently meeting the needs of their customers and other stakeholders alike, simultaneously fulfilling any statutory or regulatory requirements related to the product. Generally, the ISO 9000 series (along with the more industry specific standards such as ISO13485 for medical device manufacturers) is considered to give a comprehensive set of instructions for quality management system principles, and to show how they can collectively form the basis for performance improvement and organizational excellence.
One critical concept in achieving the goals set by quality management system standards is to continually monitor and assess the various processes for their efficiency and performance. Nonconformances or opportunities for improvement may be noted during periodical quality audits, based on customer complaints or requests, or during every day manufacturing activities. Utilizing this information, the organization stands to gain significant performance advantages through improved organizational capabilities. If performed actively and vigilantly enough, it also warrants the manufacturer the opportunity to react proactively, shifting their focus from corrective actions to preventive actions.
Predisys Quality Management modules offers organizations a modular set of digital solutions which help gather, collect and distribute this kid of quality information. For companies operating in FDA regulated enivironment, the solution contains secure (CFR 21 Part 11 compliant) electronic signatures and audit trails. The solution utilizes automatic workflows, significantly reduces the amount of time taken to process and distribute the paperwork. Attachments (drawings, pictures, graphs etc.) can be attached to the digital applications when needed for additional clarification. Extensive document search capability allows for analysis and cross-referencing of information contained within the applications.