Introduction While many organizations have a dedicated Computer System Validation (CSV) team, CSV is never a solo effort. That being said, how do we explain the concepts and basics to those who support CSV, but may not be too familiar with the process? ISPE’s GAMP 5, A Risk-Based Approach to Compliant GxP Computerized Systems is
What do we do when we need to validate ten or even twenty of the same computerized system? While it’s technically valid to create unique validation documentation and perform identical testing on each system, this is wildly inefficient from a time and financial perspective. Instead, one can create a risk-based plan to validate a family
In GxP environments, such as pharmaceuticals, biotech, and food industries, strict regulatory compliance and data integrity make robust data architecture essential. Here we delve into: effective folder structures, permission management, and user account controls are critical to ensuring security and compliance. Using Active Directory (AD) groups over individual access levels simplifies management, while regular permission
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
Infrastructure qualification is a critical process in ensuring that equipment, systems, and facilities are fit for their intended use in regulated industries, particularly in pharmaceuticals and biotechnology. The process involves rigorous testing, change control, and extensive documentation to meet compliance standards and ensure continuous improvement. This blog will break down the stages of Infrastructure Qualification
21 CFR Part 11 has been in effect for over 25 years, but in an ever-modernizing digital environment, Part 11 compliance is more important than ever. In a nutshell, Part 11 sets forth requirements that GxP electronic records and electronic signatures are required to meet. While the scope of the regulation is not terribly difficult
Computer System Validation (CSV) can often feel like a significant speed bump for growing companies looking to transition into the GMP space. It requires resources and considerations that are often not yet taken into account. While this may be more applicable to budding startups, veteran corporations can also find themselves in this situation. In an
In software development for regulated industries, ensuring compliance with regulations such as 21 CFR Part 11 and EU Annex 11 requires a systematic and structured approach. In this blog, we explore how adhering to the principles of ISPE GAMP® 5, can guide software providers in aligning their activities to ensure compliance. In this blog, let’s
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