Why CSV Matters in Regulated Industries
Introduction Computer System Validation consists of the activity necessary to confirm that computer systems perform their intended functions reliably, accurately, and consistently in a regulated environment. The testing and documentation of software and hardware systems are included in this, ensuring they meet predefined specifications and regulatory requirements. CSV is not only meant to confirm system […]
Change Control in CSV: Handling System Updates Without Risk
Introduction Change control is one of the most important elements of CSV, which provides assurance that changes to validated systems are examined systematically, documented, and implemented without compromising the system’s integrity, compliance status, or intended function. In regulated industries like pharmaceuticals, biotechnology, and medical devices, where computerized systems manage data impacting product quality and patient […]
Validating Excelsheets: Effective Approaches to Improve Data Accuracy
Data integrity is everything in today’s modern world. Whether it deals with financial reports, sales forecasts, or inventory tracking, several business outcomes are hinged on data accuracy. Excel sheets, being versatile, are used across industries to handle data. However, human error and incorrect formulas and inconsistency in data entry can jeopardize the accuracy of the […]
Continuous Validation: Is It the Future of CSV?
Introduction Explanation of Continuous Validation (CV) and its relevance in the context of Computer System Validation (CSV). Continuous Validation (CV) is an advanced approach to ensuring that computerized systems remain in a validated state throughout their lifecycle. Unlike traditional Computerized System Validation (CSV), which follows a one-time validation process at a specific point in time, […]
Transforming Business for Good: The Intersection of Digital Innovation and CSV
Introduction Digital transformation represents a strategic shift in how organizations operate, compete, and deliver value by leveraging advanced technologies. It’s more than the adoption of new tools—it requires a fundamental rethinking of traditional processes, customer engagement, and decision-making. With technologies such as cloud computing, artificial intelligence (AI), automation, and data analytics, businesses are streamlining workflows, […]
What Is FDA 21 CFR Part 11? A Guide for Computer System Validation Professionals
Introduction FDA 21 CFR Part 11 is a key regulation that governs the use of electronic signatures and electronic records in the pharmaceutical, biotech, medical device, and other FDA-regulated industries. Initially published in 1997, this regulation ensures that electronic records and electronic signatures are as trustworthy, dependable, and equivalent to handwritten signatures and paper records. […]
Top Challenges and Benefits of Integrating Laboratory Instruments with LIMS
Introduction A Laboratory Information Management System (LIMS) is an application software that automates and manages the laboratory processes, tracking of data, sample handling, automation of workflow, and compliance with regulations. LIMS is applied in several industries, including pharmaceuticals, biotechnology, environmental analysis, clinical diagnostics, and food and beverage analysis. Sample lifecycle management, test result storage, reporting, […]
From CSV to CSA: Understanding the Shift in Software Validation
Introduction CSV (Confidentiality, Security, and Availability) and CSA (Cloud Security Alliance) are two of the most important terms in data protection and cloud computing and are tasked with serving as a backstop in today’s digitally networked world. CSV—not to be confused with the file format—refers to the foundational principles of information security: Confidentiality, ensuring data […]
Unlocking the Basics of Computerized System Validation
Introduction Computerized System Validation or CSV is an essential activity in those regulated sectors like pharmaceuticals, biotechnology, and medical devices. CSV is the documented process of confirming that a computerized system always operates as per its expected use and regulatory requirements. CSV has been made mandatory by regulatory agencies like the U.S. Food and Drug […]
Comparative Overview of Drug Regulatory Systems: FDA, EMA, and CDSCO
Introduction Regulatory systems play a vital role in ensuring that medications are safe, effective, and of high quality before reaching the public. These frameworks protect public health by enforcing stringent requirements for the approval, monitoring, and distribution of pharmaceutical products. Through comprehensive evaluations of clinical trial data, manufacturing standards, and post-marketing surveillance, regulatory authorities work […]