Custom Workflow Validation

In regulated industries such as life sciences and healthcare, validating custom workflows for processes associated with Quality Management Systems, Training, etc. is essential for meeting regulations and ensuring smooth operations. Regulatory bodies, such as FDA require comprehensive validation for healthcare products, including drugs and medical devices, as outlined in their software validation guidance. Custom workflow validation ensures that workflows function properly and meet strict regulatory standards, ultimately protecting patient health and safety. This blog explores the significance of custom workflow validation, outlines the steps involved, and highlights the risks associated with failing to validate these critical systems.

The Importance of Custom Workflow Validation

The primary goal of custom workflow validation is to ensure that workflows operate efficiently while adhering to necessary regulatory standards. Key points include:

• Risk Reduction: Validating workflows reduces risks, providing confidence that they will deliver safe, reliable, and efficient outcomes.
• Regulatory Approval: Workflows that pass validation are also more likely to gain regulatory approval, while those lacking proper validation may face increased scrutiny or additional requirements.
• Quality and Compliance: The validation process ensures regulatory alignment and fosters a culture of quality and compliance within organizations.

Steps in Custom Workflow Validation

A structured approach is vital for effective custom workflow validation. Here’s an overview of the key steps involved:

1. Identifying Workflow Requirements:

Understanding the purpose of the workflow and its regulatory requirements is the first step. This includes:

• Define requirements to establish a clear purpose.
• Outlining validation objectives to provide a roadmap for the validation effort.
• Engage stakeholders to gather expectations and align the workflows with their needs.

A structured validation plan, based on ISPE GAMP® 5 guidelines, ensures that all requirements are addressed from the beginning.

2. Gathering and Analyzing Data:

Once the requirements are clear, it’s time to collect and analyze relevant data:

• Collect relevant data from past validation efforts, industry standards, and user feedback.
• Document findings to form a foundation for a robust validation report.

Accurate documentation is crucial, as it helps identify potential risks and areas for improvement.

3. Conducting a Risk Assessment:

Risk assessment plays a crucial role in validation:

• Identify potential risks, such as workflow failures or missed steps.
• Prioritization of high-impact areas for thorough testing, following ISO 9001:2015(en) guidelines to focus resources on critical areas of the workflow.

4. Developing Test Cases:

With a clear understanding of risks, create test cases to validate the workflow’s robustness under various conditions. These should simulate everything from routine operations to edge cases, ensuring comprehensive coverage before going live.

5. Testing the Workflow:

Once test cases are prepared, conduct intensive testing in a controlled environment. This phase is essential for identifying bugs or inefficiencies that could affect performance once the workflow is operational.

6. Documenting and Communicating Results:

After testing, it’s crucial to document results and share them with stakeholders:

• Record results in a detailed validation report.
• Communicating findings to key stakeholders, including regulatory bodies, to demonstrate compliance and facilitate the approval process.

7. Ongoing Monitoring and Improvement:

• Monitor workflows continuously to ensure they remain compliant with changing regulations and company-specific quality/business needs.
• Update workflows as needed to address new challenges, maintaining long-term compliance and optimizing performance throughout the product lifecycle.

To better visualize the validation process, the flowchart below highlighting each critical phase involved illustrates the steps involved in custom workflow validation process.

Risks of Not Validating Workflows

Neglecting thorough custom workflow validation can lead to significant consequences, such as:

• Regulatory Non-Compliance:

Non-validated workflows may fail to meet regulatory standards, resulting in penalties or market withdrawal.

• Delayed Approvals:

Inadequate validation can slow down regulatory approval, affecting revenue and patient access.

• Safety Risks:

Lack of proper validation could lead to safety issues, risking patient health.

• Reputation Damage:

Failure to maintain validation processes can harm a company’s reputation, making future approvals more challenging.

Conclusion

Custom workflow validation is critical for compliance and operational efficiency in regulated industries because it helps organizations navigate regulatory challenges while prioritizing patient safety.

At PSC Software®, our expertise supports your custom workflow validation needs, and our ACE® Software streamlines the process by automating testing, tracking documentation, and ensuring regulatory compliance. PSC Software® Implementation Services works with regulated companies to deliver configured and validated custom workflows tailored to specific requirements, facilitating validation and optimizing performance across critical business/quality/training operations.