• Melita Ball

February 6, 2020 Blog Post

Computer System Validation: Why Is It Important ? (Part 1)

Hello Readers!

Computer systems and software are everywhere in our daily lives. Even the most casual user of these systems and applications is well aware of the problems that can occur when the software doesn’t perform as expected. Many have felt the reality of bank accounts being emptied overnight or being given the wrong diagnostic test results due to a computer malfunction that incorrectly linked patient names to test results. The words “Data Integrity” are the new buzz words for Life Sciences regulators all over the world. So, why is it so important and what’s required First, it is important to understand that the requirement to validate computer systems and software is not new. Global regulations and Standards have required software validation for almost five decades. What has changed, however, is the complexity of what we are able to do with software today as opposed to what we could do 50 years ago. Additionally, the connectivity of these systems is far beyond what anyone ever thought it would be back then. These advances have, without a doubt, improved our lives in many ways but they have also introduced challenges that demand diligence in software validation. I have found that many people are confused about what computer system validation (CSV) actually is and what it means for Life Sciences companies. Simply put CSV is a formal process that ultimately provides the system owners with objective evidence that their system consistently and reliably performs as expected and is in compliance with all relevant regulations, standards, laws, and industry guidance. CSV is decidedly NOT an exclusive IT endeavor. It requires participation from a number of stakeholders and is usually led by the Quality group due to the regulatory risks involved. Another unique aspect of CSV is that it applies no matter what industry segment you are in (Pharmaceutical, BioTech, Diagnostics, or durable Medical Devices). It also applies regardless of the scope or stage of your regulated activities such as, Clinical (GCP), Manufacturing (cGMP and/or ICH), or Laboratory (GLP). We also cannot forget about electronic records and electronic signature requirements found in 21 CFR Part 11 and the European Union (EU) Annex 11. Due to the breadth of these varying requirements, most industry experts simply use the term “GxP” to refer collectively to all the relevant areas listed above. If a computer system or software application is considered “GxP relevant,” then software validation is required. Knowing that software validation is required (and has been for almost 50 years) is only part of the equation. The planning and resources required to successfully validate these systems is not typically a small investment for large, complex organizations. Most CSV disasters stem from either

  1. Not recognizing that CSV needs to be budgeted into the overall cost of the system before purchasing it, and/or

  2. Not planning for CSV from the beginning of the effort to implement a computer system.

Finally, the business owner of these systems will be held accountable by regulators for the ability of the software to perform reliably and to produce accurate records that are required under the various regulations and standards. But that’s not the real reason for understanding the importance of performing software validation correctly. One of the real business benefits is that end users will have a reliable system with which to perform their work. This, in turn, increases performance and decreases downtime. When it is done well, it also leads to uneventful inspections and audits because a well validated system is easy to defend to regulators and greatly assists the organization’s ability to demonstrate competence and compliance. In Part 2 of this series I will break down the CSV Process using a risk-based approach. Thoughts? Please comment below … Cheers! Melita Ball CEO and Principal Consultant

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