Computer System Validation in the Digital Age
Many of the industries are subject to laws, regulations, and government oversight, because they may impact people’s lives, safety, and well-being. Not complying can potentially lead to lost lives, hefty penalties, reputational damage, or all the above.
If you are in a regulated industry, you might know the term Computer System Validation (CSV). It means to validate the regulated computer systems, to ensure that they do exactly what they are designed to do in a consistent and reproducible manner. CSV is enforced by some regulations, for example, the US Food and Drug Administration 21 CFR Part 11 and Eudralex Vol. 4 Annex 11 explicitly describe CSV. Some other industry regulations, though not using the word CSV, also require stringent verification. For example, banks must comply to the Anti-Money Laundering (AML) laws and validate the computerized AML system to ensure its effectiveness, accuracy, and robustness.
The COVID-19 pandemic accelerated the use of digital solutions in regulated industries. They now enjoy the benefits from it and want more digital innovations. As a result, more computer systems must undergo validation. Read on to find out how application lifecycle management tools can alleviate the challenges of CSV and make the process more efficient.
Challenges in Computer System Validation
Staying compliant isn’t easy. Let’s look at some common challenges in CSV:
Keeping up with deadlines
CSV projects often require significant resources—time, people, and money. However, CSV must be complete before you can use these systems in production. Securing the necessary resources can be a challenge, especially if you have limited budgets or competing priorities.
With limited resources, it’s important to identify and prioritize critical functions. But doing so requires a thorough understanding of system functionality, business processes, and risks. Besides, it’s difficult to design and execute tests that cover all relevant scenarios, especially for large, complex systems.
Comprehensive validation documentation
Creating and maintaining it can be time-consuming and resource intensive. Documentation includes validation plans, protocols, test scripts, and summary reports. You also need to ensure the accuracy, completeness, and traceability of documentation throughout the computer system lifecycle.
You must establish mechanisms to handle system updates, patches, and ongoing maintenance while ensuring that changes do not compromise the validated state.
Keeping up to date with evolving regulations
Emerging technologies, new safety concerns, new industry practices, and political factors may all trigger regulation revisions. Accordingly, you need to update your CSV requirements and validate it again. With the availability of generative AI, new regulations are appearing to enforce detailed validation of the systems using this technology.
Coordinating with employees, vendors, and partners. During the validation process, you need to ensure that all participants can smoothly communicate, submit documentation, conduct testing, and adhere to processes.
Easy Computer System Validation with ALM Tools
An application lifecycle management (ALM) tool with the functionalities for CSV makes a significant difference. Although they have different purposes, ALM and CSV share key similarities. They both:
- Assess the target system against a set of requirements.
- Require documenting—from requirements and test plan to test results—and creating reports to communicate with stakeholders.
- Follow a process and workflow.
- Take care of the whole lifecycle of the target system.
Let’s look at how OpenText ALM/Quality Center (ALM/QC) can make your CSV easier.
Manage complexity and risks
The first part of CSV is to clearly define the requirements for the computer system. Then use a risk-based approach to create an effective testing strategy and focus on the most critical requirements. They can be complex, so if their relationships are not well sorted out, it’s difficult to prioritize. ALM/QC uses requirements hierarchy, dependencies, and business process models to logically keep how each requirement is related to others.
With your requirements well organized, you can use the built-in risk assessment feature to objectively score their risk level.
ALM/QC increases your CSV efficiency in multiple ways:
- Generate test cases from requirements and analyze requirement coverage.
- Boost your productivity in manual testing, automated testing, and gathering validation evidence from other sources.
- Help capture data in electronic format from the beginning—the QoT tool enables manual testing in all sorts of places and lets you digitize test results on the spot.
- Save documentation effort—the test cases, runs, results, defects, audit log, etc. naturally become the documentation, and customizable built-in graphs and reports let you create the validation summary with no hassle.
Ensure integrity and traceability of documents
Establishing traceability is hard with a paper- or Excel-based approach. In ALM/QC, you can trace bidirectionally among requirements, test cases, test runs and results, and defects. You can track all requirements to their validation artifacts, to understand coverage and identify the scope of re-validation when your requirements change.
ALM/QC disallows manipulation of actual data and automatically generates audit trails on electronic records, with details about who, when, and what happened. They can be signed with e-signature to further strengthen integrity.
Achieve continuous compliance
CSV continues throughout the system lifecycle, which means change management is key. ALM/QC helps you clearly understand the impact of changes, using versioning, baselining, and change impact analysis. You’ll find it easy to validate continuously whenever there are changes, and keep your system constantly compliant.
All the validation records across the lifecycle are kept together in ALM/QC, becoming valuable data for advanced analytics and continuous improvement.
Enforce solid validation processes
Governance of activities is another essential part of CSV. Even the strongest teams suffer quality setbacks and timeline slippage without solid processes. ALM/QC helps you enforce processes with templates, library sharing, automated workflows with e-signature, and rules embedded in your daily quality assurance activities.
Collaborate smoothly will all parties
CSV always involves SMEs and business users, and often partners and suppliers as well. ALM/QC lets them see the same point of truth, follow the same rules, and collaborate through Microsoft Teams integration, no matter where they are. Its SaaS offering ensures high business continuity for your CSV.
E-signature for ALM
When submitting electronic records as evidence of compliance, most regulations require using e-signatures. There are some e-signature solutions out in the market with strengths and weaknesses. OpenText offers an e-signature solution, and its strength is that it’s implemented on top of the workflow of OpenText ALM tools. Native e-signature performs the best, reduces the risk of glitches, and has a cost advantage. Leverage OpenText e-signature for ALM services to ensure a smooth experience.
Agile and DevOps in Computer System Validation
Though GAMP 5, the guideline adopted worldwide for GxP computerized systems, describes using the V-model in validation, regulated companies are seeing the benefits of Agile and DevOps in CSV. If you are adopting them, consider one of the following related products of ALM/Quality Center:
■ ALM Octane (off cloud, cloud BYOL)
■ ValueEdge Quality (SaaS)
They both share the same characteristics with ALM/Quality Center in stringently managing software quality, but better support Agile and DevOps practices.
Learn More about Computer System Validation
CSV does not generate revenue, yet it’s a must. OpenText ALM tools can manage your CSV highly efficiently and give you the confidence to face audits. With its help, you can focus more on digital innovations that grow your business. Contact us if you are interested.