Validation Lifecycle Management System Essentials: What to Know

To test or not to test? The truth is, there really is no question.

Whether you’re implementing a new quality management system (QMS) or updating your existing system, testing whether it works as intended is critical.

One common misconception holding companies back is the idea—based on decades-old approaches to software testing—that validation is time-consuming and expensive.

Today, validation lifecycle management systems have flipped that script, making it far simpler to test your QMS so it’s ready to perform the day you go live.

This article explores the essentials of validation lifecycle management systems for companies deploying or updating their QMS, covering topics such as:

• The benefits of validation for regulated and non-regulated companies
• Why a lifecycle approach is critical to robust validation
• How computer system assurance (CSA) changes the game
• Why and how companies can simplify validation with automated solutions

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Benefits of Validation

Software validation is a mandated requirement in regulated industries such as pharmaceutical, medical device, and food manufacturing. However, any company can benefit from software testing, providing advantages such as:

• Reduced costs: Detecting bugs in the early stages of implementation is far less costly and complex than fixing problems after development is complete.
• Accelerated deployment: Identifying potential defects early on helps streamline implementation so you can roll out software faster.
• Improved product quality: Software testing ensures the final product is bug-free and meets the needs of users.
• Increased user satisfaction: When software performs as intended and meets users’ expectations, this enhances user adoption for a more successful implementation overall.
• A structured process: Coordinated software testing provides a structured process that helps teams work better together and make the best use of their time.

Understanding the Software Validation Lifecycle

Far too often, companies start the validation process at the end of software implementation, rather than taking a lifecycle approach that incorporates testing from the very beginning. Software validation also requires periodic review, testing, and maintenance to ensure the solution continues to meet your business requirements.

From a high-level standpoint, the software validation lifecycle is comprised of five general steps:

1. Requirement management: The first step is collaborating with stakeholders to document all functional and non-functional requirements, including user requirements, regulatory requirements, and performance requirements.
2. Project and validation planning: Your validation plan should detail the scope of validation, timelines, activities, and protocols you will execute, as well as acceptance criteria.
3. Testing: Here is where you perform different types of testing, including functional, performance, and usability testing. Validation protocols document testing activities, including test procedures, test cases, expected results, and acceptance criteria.
4. Reporting: After all testing is complete, the validation report summarizes the results, any deviations, and the overall validation status. For regulated companies, this report then serves as evidence that you’ve validated your software.
5. Maintenance: Periodic reviews and documentation updates should occur to ensure compliance and address any issues with the software or updates that require changes.

Common Challenges with Software Validation

Preparing all of the necessary documentation as part of your validation process can be time-consuming and complex, particularly if you are using an on-premise QMS where every element must be validated.

Audit readiness is also a top challenge for FDA-regulated companies, who may face stiff consequences if they are found to be out of compliance. Common FDA observations include:

• Failure to validate a regulated system
• Lack of written procedures
• Not following written procedures
• Failure to maintain records

FDA-regulated manufacturers must revalidate their system every time an upgrade or system change takes place to maintain a continuous state of validation. Those using a cloud-based QMS can leverage vendor validation activities, eliminating duplication of effort where adequate testing has already been completed by the vendor. Robust document management is essential to audit readiness, and one area where an integrated validation management solution can provide significant benefit.

Why Automate Validation

In the past, paper-based validation approaches required extensive time and resources for compiling documentation, performing testing, printing reports, and obtaining manual signatures. Not only are traditional validation processes time-consuming, they’re also prone to error, increasing the risk of external audit findings and quality issues.

Other disadvantages to paper-based validation include:

• High operational costs associated with having to track and manage paper records
• Issues with traceability of requirements
• Inability to reuse artifacts and evidence
• Poor visibility into validations of similar systems

Conversely, a validation lifecycle management system delivers a paperless process for managing requirements, conducting risk assessments, executing test scripts, and generating reports. Below, we look more closely at some of the benefits of using an automated validation management system.

Save Time and Money

A validation management solution integrated with your QMS reduces the time and resources required for validation with a comprehensive methodology that covers the entire software development lifecycle, including:

• Requirements management
• Validation planning
• Risk assessment
• Protocol authoring
• Traceability management
• Test case execution
• Periodic review
• Change control
• System assessment

For companies that implement a cloud-based rather than on-premise QMS, the burden of validation is automatically reduced by roughly 75%. With a cloud-based QMS, the core process has already been validated, and you need only validate user needs and configuration changes. The vendor is responsible for a larger proportion of validation documentation, reducing the burden on manufacturers in the process.

Accelerate Release

Incorporating validation into the implementation process from the beginning allows you to find and fix issues faster. This streamlines your deployment overall, as you don’t have to spend time on the back end addressing problems that could have been detected earlier.

A validation management solution integrated with your QMS also reduces the complexity of validation, with all of your documentation automatically residing in the system. This is in contrast with needing to integrate external validation systems, which involves mapping and uploading documentation.

The end result: faster time-to-value with your QMS and a higher-quality product that meets user needs.

Maintain Audit Readiness

Automating your validation process helps minimize compliance risk and ensure a continuous state of audit readiness by:

• Centralizing all necessary information and documentation in one place
• Enforcing consistency and standardization in the process
• Preventing data integrity issues

What to Look for in a Validation Lifecycle Management System

An automated validation management solution should generate all of the necessary templates and deliverables you need, including:

• User and functional requirement specification
• Risk assessments
• Requirement traceability matrix
• Validation plans
• Validation summary
• Test protocols
• Detailed reports

Automated regression tools also make it simple to ensure a continuous state of compliance. That means if you upgrade your software, add a configuration change or implement a new process, the tool automatically runs the regression script in the background and takes screenshots to document the results. With an automated tool, the time required to perform testing can shrink from a full week to just a few hours.

Validation Services Finding a Trusted Partner

Many companies opt to validate their QMS internally with the support of their QA team. However, those without internal resources to support validation can still protect their QMS from configuration or implementation issues by leveraging the vendor’s validation services to:

• Create all required deliverables from start to finish
• Ensure you’re audit-ready and in compliance from day one
• Ensure implementation and configuration changes are developed correctly
• Proactively identify potential issues during development
• Make sure all integrations are compatible and working properly
• Identify risks for better decision-making around user needs
• Keep validation projects within time and budget constraints

For example, a vendor can test the workflow a user would use to add a new device in the QMS. Once testing is complete, those test scripts can then serve as the foundation for user documentation, helping further streamline implementation and user adoption.

The key is finding a vendor that works with you starting at the requirements gathering step, rather than as the final step in the implementation process.

Validation FAQs

If you’re like many companies, you likely have many questions around validation. What actually needs to be tested? Do you have to validate everything? Do you need to test your software if you’re not a regulated company? We look at the answers to these and other questions below.

Do we need to test everything?

Companies must validate user needs. If you’re using a cloud-based QMS, the main core process has already been validated. From there, regulated companies must validate the system against their user needs and intended use by running a PQ, as well as validating any configuration changes with user needs.

Do the deliverables have to be updated?

If you make a change to your system, deliverables that need to be updated include:

• Requirement specification or configuration specification
• Risk assessment
• Validation plan
• Validation testing

What has to be tested for a software update?

Companies using a cloud-based QMS are able to leverage the vendor’s validation activities, including the risk assessment and validation summary report. The vendor should be able to provide these for any type of system update. They also need to review and perform their own risk assessment to ensure adequate testing was performed so that user requirements were not affected.

Companies with an on-premise QMS will need to conduct their own validation on the changes and perform regression testing if necessary.

Do we need to test our software if we aren’t a regulated company?

Software testing is beneficial for any company, ensuring the system meets your users’ needs and performs as intended. Performing software validation helps identify defects and bugs early in the process before they snowball into larger problems.

Conclusion

Software testing is an important yet often overlooked element that can make or break the success of your QMS deployment. Automated validation lifecycle management tools combined with robust vendor testing services remove the guesswork, so companies can maintain a continuous state of compliance and reliability for their QMS.

About the Author

Victoria Alestra has over 15 years of experience in software validation across various industries including life-sciences, manufacturing, energy/utilities, financial security and healthcare. She possesses a deep understanding of quality assurance methodologies and has a proven track record in delivering high-quality software validation. Victoria specializes in working closely with our customers to ensure compliance with their specific requirements and expectations, in addition to leading an independent validation team, where her strong analytical skills and attention to detail plays a crucial role in ensuring error-free releases of software. With her comprehensive understanding of software quality and commitment to delivering exceptional service, Victoria continues to drive innovation and excellence for our customers and within AssurX.