When quality issues occur, fixing the immediate problem isn’t enough. Organizations also need to understand why it happened and make sure it doesn’t happen again. That’s the purpose of CAPA, or Corrective and Preventive Action. CAPA is a structured quality process used to identify nonconformances, analyze root causes, implement corrective actions, and prevent future issues. It plays a...
As cybersecurity threats continue to escalate across industries, ensuring the security and integrity of information systems has never been more critical. ColumbiaSoft is proud to announce the successful renewal of its SOC 2 certification for our Document Locator software, demonstrating our continued commitment to the highest standards of data protection and trust. Why SOC 2 Matters More Than...
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,...
As data security concerns rise, SOC-2 certification has become an essential benchmark for organizations handling sensitive information. ColumbiaSoft is pleased to announce the renewal of its SOC-2 certification for its flagship Document Locator software, validating once again our commitment to robust security standards. Why SOC-2 Certification Matters The Service Organization Control (SOC) 2 audit is a rigorous process governed...
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...
We're excited to announce the latest release of Document Locator, Version 21.4. This version continues to build on our commitment to making document control more intuitive, efficient, and secure. Here's a closer look at what's new in Version 21.4 and how it enhances the features introduced in previous releases in the 21 series. What's New...
