Why Computer System Validation and Computer Software Assurance are a Must for ERP Compliance

On February 20, 2024

Navigating the complex processes of Quality Assurance (QA), Validation, and ISO 9001 certifications in Life Sciences is no easy feat.

As a Quality Assurance Manager and Validation expert, you must steer your company through the rigors of regulation during ERP implementation, ensuring your business complies with standards while maintaining the reliability, quality, and safety of your products. Non-compliance can cost you dearly, leading to legal proceedings, penalties, product recalls, and even shutdowns.

One major Pharmaceutical company, for instance, had to pay $25 million for not meeting proper manufacturing standards. As reported by Deloitte, the U.S. Food and Drug Administration found issues that took years—and $100 million in plant improvements—to resolve. During this time, the organization suffered a massive loss of billions of dollars in sales because its products were unavailable in the market.

Considering that even a small mistake can have serious consequences, managing QA and validation can be nerve-wracking. To steer clear of issues and gain trust through International Organization for Standardization (ISO) 9001 certification, companies must include Computer System Validation (CSV) and Computer Software Assurance (CSA) approaches in their quality control efforts.

In this article, we’ll explore the benefits of CSV and CSA for achieving ISO 9001 certification. As a Software as a Service (SaaS) company specializing in Life Sciences ERP and validation solutions, AX for Pharma understands the critical need for maintaining the right certifications and credentials.

Computer System Validation (CSV)

CSV is a vital process for Life Sciences companies. It ensures that computer systems used in pharmaceutical manufacturing, laboratory work, distribution, storage, and documentation meet the rules for Good Practices (GxP).

CSV covers everything from planning and defining system requirements to testing, validation reporting, system operation, maintenance, and retirement with data retention.

To carry out CSV, different methods (risk-based, lifecycle, process, Good Automated Manufacturing Practice (GAMP) category system, etc.) are used to ensure that your computer systems are functioning as intended.

CSV is essential for maintaining quality, promoting safety, and complying with regulations set by various agencies, such as the US FDA, the European Commission, and the World Health Organization. Validated systems prevent errors, data loss, fraud, and system failures, ensuring high-quality, safe, and effective products that patients need to improve their quality of life.

Computer System Assurance (CSA)

CSA is a more modern validation approach that’s dedicated to securing computer systems involved in manufacturing medicines and clinical supplies. The hallmarks of this approach include:

  • Making sure data is accurate
  • Maintaining consistent system performance
  • Safeguarding against unauthorized access
  • Putting a spotlight on critical thinking and digital technologies for efficient testing and maintenance

This proactive method ensures the smooth operation of Pharmaceutical processes, while giving top priority to cybersecurity and the reliability of systems.

Why Life Sciences Companies Should Consider CSV and CSA

Life Sciences organizations need to perform CSV and CSA for many reasons related to trust, profitability, and long-term growth. Your reputational integrity depends on:

  • Regulatory Adherence: Meeting the standards of the FDA, European Commission, World Health Organization, and Good Manufacturing Practice (GMP).
  • Risk Mitigation: Averting errors, system failures, and security breaches.
  • Quality Integration: Strengthening the overall Quality Management System.
  • Efficiency and Cost Savings: Eliminating waste and accelerating go-to-market.
  • Certification Advancement: Maintaining compliance with ISO 9001 standards.

Why is ISO 9001 Certification Important for ERP Implementation?

ISO 9001 provides a framework for organizations to establish and maintain an effective Quality Management System. Becoming ISO 9001 certified shows regulatory bodies and consumers that you’re concerned about compliance and quality. And taking the steps required to ensure that your data and computer systems are safe and reliable has the added benefit of driving sustainable growth.

ISO 9001 certification during Enterprise Resource Planning (ERP) implementation ensures that your ERP systems align with international standards, such as Quality Management, Information Security, and Environmental Management. It demonstrates a commitment to quality, regulatory compliance, and continuous process improvement by enhancing efficiency, managing risks, and meeting customer and regulatory expectations.

ISO certification plays a vital role in ensuring continuous success and sustainability of your ERP system—and your organization as a whole.

The Role of CSV and CSA in ISO 9001 Certification

CSV and CSA both play roles in achieving ISO 9001 certification for quality management (and ISO 13485 certification for medical devices), but their functions differ.

CSV helps determine how much documentation is needed, while CSA streamlines processes to simplify compliance. Knowing the difference matters because specific rules may dictate the use of one over the other.

To make informed decisions, you must explore the differences between CSV and CSA and understand how both validation approaches contribute to obtaining the ISO certification you need:

  1. Focus
    1. CSV focuses on producing accurate and approved documentation for auditors, followed by testing and critical thinking.
    2. CSA places critical thinking at the center of the process.
  2. Risk Management
    1. CSV validates that a system does what it’s designed for and complies with regulations.
    2. CSA employs a risk-based approach, instilling high confidence in system performance
  3. Innovation
    1. Traditional CSV is seen as a hurdle to automation and innovation.
    2. CSA encourages a more flexible approach, allowing various assurance approaches based on the system/feature risk. Additionally, it allows a significant reduction in documentation creation, optimizing the different validation phases.
  4. Testing Activities
    1. CSV relies on scripted and documented testing for objective evidence.
    2. CSA emphasizes critical thinking and risk-based testing; testing activities are executed mainly by the Supplier of the Computerized System, reducing the responsibilities of the company using the system.

How to Get ISO Certification through CSV and CSA

We understand that validating systems, including your ERP system, can be complex and challenging.

To obtain an ISO certification using the CSV and CSA validation approaches, you need to follow these steps:

  1. Identify the computerized systems relevant to the ISO standard and determine their risk level and assurance needs.
  2. Plan the validation strategy and approach based on ISO requirements.
  3. Define system requirements and specifications based on user needs and intended uses.
  4. Run tests and verifications to confirm the system meets the requirements and specifications.
  5. Document validation results to prove that the system is fit for its intended use. Use transparent documentation practices and digital technologies for this process.
  6. Monitor and maintain the system’s performance, security, and quality during its lifecycle and implement changes or updates as needed, following a change control process.
  7. Retire your systems and retain the system data according to the ISO rules when the system is no longer needed.

The AXP365 Validation Toolkit™: Your Guide to Easy Validation and Compliance

To help you with compliance and validation processes during implementation, we provide a valuable toolkit that focuses on the traditional (CSV) and modern (CSA) approaches to ERP implementation to help you comply with ISO 9001 standards.

The AXP365 Validation Toolkit™ has been designed to help you improve efficiency, cut validation costs, and reduce errors as you meet your GxP, GAMP 5, CSV, and CSA guidelines.

Struggling with validation? Click here to learn about the AXP365 Validation Toolkit™.