The weight of audit findings often rests on the shoulders of document control—or the lack thereof. With estimates suggesting that up to 80% of audit findings stem from document control deficiencies, it's a critical area that organizations cannot afford to overlook. In our new comprehensive guide, we provide a framework for addressing document control issues that lead to audit findings. It...
A Quality Management System (QMS) is paramount for ensuring that organizations meet the highest standards of efficiency and customer satisfaction. It provides a structured framework that helps organizations meet customer expectations and regulatory requirements while aiming for continuous improvement. But what exactly is a QMS and what makes it effective? This post dives into the essentials of a successful QMS,...
Understanding and implementing effective document control is crucial when attempting to meet regulatory standards, the core principle of which is: "Do what you say, say what you do, prove it." Document Controllers now have a comprehensive guide at their disposal. The newly available handbook dives deep into the fundamental aspects of document control for quality and compliance. This resource outlines...
In the regulated world of manufacturing, particularly within sectors that are subject to stringent standards like pharmaceuticals, medical devices, and food production, the term 'cGMP' resonates with an unfailing significance. cGMP, or current Good Manufacturing Practices, represents the cornerstone of quality assurance, outlining the practices required to conform to the regulatory standards that control the manufacture and sale of such...
Document Control software in food and beverage production and safety streamlines processes, helping your organization to meet regulatory guidelines, improve quality, and increase efficiency and productivity. It is imperative for food and beverage manufacturers to attain and uphold regulatory compliance, maintain quality standards, manage recalls, standardize processes, facilitate collaboration, and enhance security. These objectives necessitate the creation, management, and control of...
Many organizations, especially those involved in manufacturing, engineering, and production, must develop and adhere to strict standards to ensure the output of what they produce meets quality and safety expectations. Quality control guidelines take a considerable amount of forethought and planning. It’s an ongoing process that requires continual evaluation and adjustment to ensure processes run smoothly and output expectations are...
I've been a quality professional since 1981, and during my career I’ve held positions as a lead auditor, quality manager, director of quality, an independent ISO Consultant and a registrar auditor for ISO 9001, AS 9100, ISO 14000 and ISO 13485. As an auditor, 80% of audit findings were document control issues. That’s why it’s so important that your method for...
Over a million companies are ISO-9001 certified. ISO-9001 is the worldwide standard for maintaining a Quality Management System (QMS). Document control software helps organizations meet these standards with greater ease and effectiveness. Managing the documentation for ISO-9001 compliance is no small undertaking. In the very early days of ISO-9001, document control was accomplished with a typewriter and a three-ring binder. Today...
When it comes to maintaining compliance with standards and regulations, a comprehensive document control software solution can be extremely valuable. When compared to paper-based solutions, or manual file management in a shared server environment, document control software has extreme advantages. It has built in intelligence that not only ensures files are managed properly by the appropriate users, but it also...
Managing procedures can be a real challenge. This is especially true if your program is paper-based. But even if your procedures are electronic, if you don't have the necessary document control practices in place, you are probably still challenged with keeping the correct versions up to date and chasing down approvals. ColumbiaSoft Solutions Engineer Dave Howell recently covered the subject of...
