Data integrity remains a critical focal point for regulatory agencies overseeing the pharmaceutical and biotechnology industries. Ensuring data integrity is not merely a compliance requirement; it’s fundamental to patient safety, product quality, and operational efficiency. This article explores the significance of data integrity in Good Practice (GxP) systems, common challenges organizations face, and best practices
Computerized systems, within the pharma and biotech industry, must be reliable, secure, and fully compliant with industry regulations and that’s where Computerized System Validation (CSV) comes in! It ensures that these systems function as intended, maintain data integrity, and meet regulatory requirements. The Validation Plan (VP) and the Validation Summary Report (VSR) are two key
Computer System Validation (CSV) ensures that computerized systems comply with regulatory requirements, safeguarding patient safety, data integrity, and product quality. Two critical documents in the CSV lifecycle are the Design Specification (DS) and the Configuration Specification (CS). These documents are instrumental in establishing how systems are developed, implemented, and maintained to meet both user and
A well-crafted Functional Requirements Specification (FRS) is a crucial component of the Computerized System Validation (CSV) process in regulated industries. This document outlines the specific functionalities and requirements that a system must meet to satisfy user needs and regulatory compliance. Let’s explore what makes a great FRS and how to approach its development. Purpose of
Quality agreements are vital documents that outline the roles, responsibilities, and expectations between a company and its suppliers. For pharmaceutical companies, ensuring quality throughout the supply chain is crucial for compliance with regulatory requirements and maintaining product integrity. Here are key considerations to include in a quality agreement for suppliers. Introduction/Purpose/Scope 1. Parties to the
In the pharmaceutical industry, ensuring the quality, reliability, and compliance of computer systems is critical. This is where Computer System Validation (CSV) plays a pivotal role. However, while CSV itself is a structured approach to ensuring systems perform their intended functions, it is the Quality Assurance (QA) team that ensures these validations meet regulatory requirements
The User Requirements Specification (URS) is a critical document in the Computer System Validation (CSV) lifecycle. A URS defines what a computerized system must achieve to support business-critical functions and comply with regulatory standards. This blog explores the essentials of developing a URS, highlighting its purpose, key components, and best practices. Purpose of a URS
What is Computer System Validation (CSV)? CSV is a structured process that documents and tests GxP computer systems to ensure they meet predefined specifications and regulatory requirements. This involves rigorous testing and documentation to demonstrate that systems are installed correctly, operate as expected, and produce reliable results. For biotech and pharma companies, CSV is crucial
For FDA-regulated pharma and biotech companies, computer systems used in GxP environments must adhere to Electronic Records and Electronic Signatures (ERES) requirements, as governed by FDA 21 CFR Part 11 to ensure data integrity, product quality, and patient safety. Computer systems that create, modify, maintain, archive, retrieve, or transmit records required by GxP regulations (e.g.
As a clinical startup, establishing a supplier management program and managing supplier relationships is critical to ensuring the quality, safety, and efficacy of clinical products and therapies. A supplier management program defines the standards to evaluate, qualify, monitor, and requalify a company’s suppliers. This program is a holistic approach to ensuring your suppliers meet regulatory