The process of validating a computer system is critical in regulated industries to ensure that the system/software produces data that meets specific requirements and consistently performs as intended. This validation process is known as Computer System Validation (CSV) and is widely followed in industries such as pharmaceuticals and medical devices, which are closely monitored by regulatory bodies such as the USFDA (U.S. Food and Drug Administration), MHRA (Medicines and Healthcare products Regulatory Agency), and WHO (World Health Organization). These regulatory bodies have also set guidelines that make CSV an integral part of the product manufacturing process.
As per the CSV process, it is necessary to furnish documented evidence that the system/software can effectively perform in the production environment. This ensures efficient operation and high-quality product outcomes that meet predetermined specifications and adhere to good manufacturing practices. Further, failure to comply with any validation may result in substandard outputs during the manufacturing and testing phases of the product. Additionally, failure to demonstrate the CSV process and outcomes at regulatory inspections can have severe legal and financial consequences for an organization, such as receiving a warning letter or an import alert.
What is CSV?
Computer System Validation (CSV) is a process of documenting and testing computer systems, including hardware, software, and associated procedures, and collecting evidence to ensure that they meet their intended use and comply with regulatory requirements. The primary goal of CSV is to demonstrate that the computer system is reliable, consistent, and performs accurately over time. The validation process includes various activities, such as gathering user and system requirements, testing, documenting, and performing ongoing maintenance to ensure the system functions as intended and meets necessary standards. The purpose of CSV is to minimize the risk of errors or failures in computer systems, which can result in inaccurate data, system downtime, or compliance issues. Additionally, CSV in a GxP environment involves review and analysis activities such as testing, walkthroughs, and inspections that can be conducted without executing the software. The focus of computer system validation is to generate documented evidence that is readily available to FDA inspectors. Moreover, according to guidelines in the 21 CFR Part 11[1], paper records can be replaced by electronic records and can have electronic signatures that are as secure as handwritten signatures. To address this guideline, businesses operating in the GxP environment need to perform Computer System Validation (CSV) of their equipment and applications.
Who Needs Computer System Validation and Stages Involved in CSV?
Industries that rely on computer systems to support crucial processes, such as pharmaceuticals, medical devices, and other regulated sectors, require Computer System Validation (CSV) to be carried out. These industries face rigorous regulatory demands, and non-compliance can lead to severe consequences, including regulatory fines, product recalls, and damage to their reputation. CSV is a critical process that helps identify and address any defects in the product or manufacturing process. Additionally, companies that handle sensitive data or confidential information must also perform CSV to ensure the integrity and security of their computer systems.
Companies that are legally required to perform Computer System Validation are:
- Pharmaceutical companies that manufacture drugs to treat diseases and distribute them to regulated markets.
- Medical device distributors involved in equipment used for diagnosis, treatment, or prevention of illnesses.
- Biological companies that deal in products related to therapeutic serums, viruses, or vaccines used for disease prevention and treatment.
- Storage and distribution providers that store pharmaceuticals, biologicals, or cell-and-tissue products.
The validation process typically involves several stages, including design qualification, installation qualification, operational qualification, and performance qualification. These stages are designed to ensure that the system meets specific requirements and operates correctly within its intended environment.
Challenges in Performing CSV Activity
- Complexities of computer systems and applications: With the ever-increasing complexity of computer systems and applications, it can be challenging to ensure that each functionality of the system or application is fully validated according to the User Requirements Document (URD).
- Lack of expertise: Many companies lack personnel with the necessary expertise in CSV across systems and applications, which can make it difficult to ensure that the respective systems and applications are properly validated according to regulatory requirements.
- Third-party systems: The use of third-party systems that are not under the direct control of the company makes it difficult to ensure that these systems are properly validated and that each functionality is tested.
- Ensuring data integrity: It is a critical aspect of CSV, but it can be challenging to verify that all data generated in the respective system is accurate and complete. Detailed validation documentation should be prepared to demonstrate the checks and validations that have been done on the system and application.
- Resource availability: CSV can be a time-consuming task, especially for large systems and complex applications. These may require significant resources and attention for an extended period, leading to a situation in which resources are tied up in CSV activities and unable to focus on other tasks.
- Incorrect interpretation: Most regulations often contain overarching statements that establish objectives without detailing how to implement controls or determine adequate levels of compliance. Ensuring consistent interpretation and execution of compliance regulations into technical controls and procedural controls for managing access is essential.
- Report approval delays: One of the biggest challenges in computer system validation is the delay in approving validation reports. The approval process can be time-consuming, as it involves multiple stakeholders, including the validation team, quality assurance, and senior management. Any delays in the approval process can lead to a delay in the release of the system and impact the overall project timeline. Moreover, if the system is already in use, any delays in approving the validation report may result in non-compliance, which can have serious consequences for the organization.
- Maintaining documentation standards: With multiple teams, organizations often face the challenge of managing multiple documentation standards across their company, as policies, procedures, work instructions, and templates may differ by business, department, or site. This can lead to significant costs due to overlapping standard operating procedures (SOPs) and inconsistent standards.
- Decentralized governance model: Fragmenting CSV activities is a common problem within organizations regarding project ownership and resources vary across departments. Some projects may be led by the IT department, others by users or quality teams, resulting in inconsistencies and inefficiencies such as duplicate efforts, increased costs, and delays in project timelines. Furthermore, differences in standards, policies, and procedures across departments can make it difficult to share assets and collaborate effectively. This model poses significant challenges for organizations in terms of maintaining quality and compliance in computer system validation.
Common Reasons for Failure of CSV
Despite being a critical activity for regulated industries, regulatory inspections often reveal failures in the process. Some of the reasons for these failures include:
- Inadequate planning and risk management
- Poor documentation practices, such as inadequate traceability and incomplete records
- Inadequate testing and insufficient training of resources can cause issues in the validation process
- Lack of ongoing maintenance and review of the validated system can lead to issues and ultimately the failure of CSV
- Insufficiently documented clarification of anticipated outcomes
It is crucial to address these common reasons for failure and take proactive measures to ensure that the validation process is successful.
Role of Third-Party Consultants in CSV and How It Helps in Regulatory Audit
CSV consultants are well-versed in the latest trends and best practices of the regulatory environment, and their expertise can prove useful for organizations in identifying and streamlining systems that are subject to legal regulations. With their knowledge of the latest industry approaches to validations and their subject matter expertise, CSV consultants can help reduce the effort and operational costs associated with the validation process.
Having an independent, third-party consultant perform Computer System Validation (CSV) activities can increase the confidence of stakeholders and regulatory bodies. The involvement and report issued by the third-party consultant add an extra layer of assurance that the validation process has been conducted impartially and in compliance with regulatory requirements.
In conclusion, organizations operating in regulated industries need to proactively perform Computer Systems Validation (CSV) to ensure Good Practice (GxP) compliance and avoid any regulatory penalties or reputational damage. By performing CSV, organizations can verify that their computer systems are functioning as intended and are meeting specific standards and requirements.
About Ankura CSV Offering
Ankura Consulting's Computer System Validation (CSV) service is a part of the Data Analytics and Technology practice that supports clients in managing their CSV program and ensuring that computer systems are operating in accordance with their intended use and regulatory requirements. The service involves performing a series of activities that verify and document the design, development, testing, implementation, and maintenance of computer systems to demonstrate their accuracy, reliability, and security. Additionally, Ankura Consulting's CSV service provides clients with an independent CSV report.
Overall, Ankura Consulting's CSV capability offers a comprehensive set of services to help clients manage the CSV process efficiently and effectively and reduce compliance and regulatory risk.
© Copyright 2023. The views expressed herein are those of the author(s) and not necessarily the views of Ankura Consulting Group, LLC., its management, its subsidiaries, its affiliates, or its other professionals. Ankura is not a law firm and cannot provide legal advice.
