No matter where you are in your ISO 9001 journey, strengthening your document control and quality management processes is one of the most important steps you can take. These two areas form the backbone of conformity and are also where most audit findings occur. The ISO 9001 Readiness Assessment is a practical...
In industries like pharmaceuticals, food production, and manufacturing—the Certificate of Analysis (COA) plays a critical role. It serves as an official document that certifies a product has met specified standards and regulatory requirements, ensuring safety, consistency, and reliability. A structured document control system plays a crucial role in managing COAs, enhancing quality...
In quality management and compliance, maintaining an accurate and up-to-date document register is essential. Organizations striving to meet standards such as ISO 9001 must ensure their documents are well-organized, controlled, and accessible. A document register serves as a structured inventory of all controlled documents, providing a single source of truth for policies, procedures, work instructions, and records...
Achieving quality and compliance isn’t just about meeting standards—it’s about creating a foundation of trust, accountability, and operational excellence. The principle of “Say it, Do it, Prove it” provides a clear roadmap for organizations to define their processes, execute them consistently, and demonstrate compliance with confidence. To help organizations implement this approach, we’ve developed a comprehensive guide,...
Audit success hinges on having a well-structured document control system. For document controllers, ensuring that all documents are properly managed, organized, and compliant is critical—whether you're preparing for an external audit or conducting an internal document control audit review. Our document control audit checklist, specifically designed with document controllers in mind, guides you through every stage of...
In manufacturing, maintaining high standards of quality and compliance is crucial. Key practices such as document control, quality assurance, records management, and training play a vital role in ensuring that all processes are efficient, accurate, and up to date. A robust document control system aids in implementing these practices by centralizing documents and streamlining workflows. This article...
Among the essential features of document control software is version control, which captures a record of every change made to a file, tracking its history, who made the changes, and when they were made. Our new guide, "The Essentials of Version Control for Quality and Compliance," is an indispensable resource for organizations striving to enhance their document control...
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...
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....
