Medical device manufacturers bringing new products to the U.S. market must choose between two FDA pathways – the 510(k) or PMA (Premarket Approval). Both routes involve regulatory requirements for proving device safety and effectiveness, but there are finer nuances between the two processes. This article breaks down key aspects in which 510(k) and PMA filings…
Introduction to OSHA Regulations The Occupational Safety and Health Administration (OSHA) is a federal agency that oversees workplace safety and health regulations in the United States. OSHA was created by the Occupational Safety and Health Act of 1970 with the goal of ensuring safe and healthful working conditions for workers by setting and enforcing standards….
With free cloud storage platforms like Google Drive and Microsoft OneDrive gaining popularity, some organizations consider relying on them for document control. But despite useful capabilities for consumer file sharing, using them as the central document management system poses major risks across compliance, quality, security and Process integrity. Limitations of Google Drive & OneDrive On…
A robust corrective and preventive action (CAPA) procedure is a fundamental component of any quality management system. CAPA provides a closed-loop process to identify, address, and eliminate nonconformances while preventing future occurrences. When consistently executed, CAPA improves product quality, reduces costs, and enhances customer satisfaction. But for many companies, the manual effort involved makes CAPA…
Medical laboratories play a vital role in healthcare, providing essential testing and diagnostic services that guide medical decisions and treatment. But errors or inaccuracies in lab testing can have severe consequences for patients and care providers. ISO 15189 is an international standard developed specifically for medical laboratories to promote accuracy, quality, and reliability in their…
In the rapidly evolving landscape of business operations, compliance management stands out as a critical component. Ensuring adherence to regulatory standards, industry guidelines, and internal policies is not only essential for legal reasons but also for building trust with stakeholders. However, the path to effective compliance management is fraught with challenges. In this comprehensive guide,…
Maintaining detailed, accurate audit trails is a critical component of any quality management system. But manually tracking and documenting audit trails can be extremely tedious and inefficient. Fortunately, advanced quality management software like PERFEQTA allows organizations to automate audit trail processes, enhancing both productivity and data integrity. What Is An Audit Trail? An audit trail…
For modern enterprises, delivering consistent, flawless products and services is an imperative for success. But relying on manual, fragmented quality management processes can hamper efficiency, consistency, and compliance. In this guide, we outline how organizations can digitally transform cumbersome quality management workflows using PERFEQTA’s integrated document management and process automation platform. The High Cost of…
In today’s fast-paced digital landscape, businesses and individuals alike rely on a multitude of software applications to streamline their operations, enhance productivity, and stay competitive. While the convenience of having specialized tools for every task is undeniable, the hidden costs associated with using multiple software solutions often go unnoticed. In this detailed exploration, we will…
While paper may seem simple and cheap, organizations are often unaware of the monumental hidden costs and inefficiencies of paper-based document management. When evaluating paper processes, most businesses only look at the upfront cost of paper, printing, and filing supplies. However, the overhead needed to store, manage, secure, find and route paper documents contributes significant…