If you work in quality management you probably know that the effectiveness of a Quality Management System (QMS) relies extensively on enterprise-wide collaboration and begins with a solid process for managing critical/important documents, such as standard operating procedures. As business and its processes rapidly evolve these days, many organizations struggle to stay current in a sea of change. Therefore, it’s not surprising that Document Management remains at the very top of quality management processes being automated, especially within highly regulated industries.
A robust document control process lies at the heart of a quality management system. Nearly every element of auditing and compliance is verified by examining documented evidence. That’s the regulatory inspectors’ bread and butter, so to stay compliant, you need to keep your organization’s documents fresh and handy.
A well-designed, documented system has many benefits. It ensures quality standards are routinely met, minimizes the potential for error, reduces downtime when deviations occur due to being able to quickly access relevant data, and allows for easy monitoring of the processes such that process outputs are analyzed and appropriate adjustments are made. QMS documentation fulfills many functions such as communication of information, providing evidence of conformity, and sharing knowledge and as such many different types and levels of needed documents, for example, a quality manual, quality policy, documented procedures, and work instructions.
In this whitepaper, we talk about 15 salient points that strongly recommend the roll-out of an Electronic Document Management System (EDMS) consisting of Document Control, Training, and Change Management.
