Automating Validation Lifecycle Management with ProcessX

Learn how VLM strengthens GxP compliance within validation, quality, and IT teams and empowers senior leadership to reallocate staff, resources, and budget to value-added activities.

What is validation lifecycle management? VLM provides a continuous feedback loop during system, equipment, and software validation. It verifies that assessments, deliverables, testing, and implementation adhere to validation requirements while the system, equipment, or software is in use. It ensures that your organization enforces standardization, optimizes processes, achieves data integrity, reduces risks, and maintains regulatory compliance.

What does VLM look like across an organization?

How does validation lifecycle management strengthen GxP compliance and help life sciences organizations stay competitive? For starters:

• The Validation team is able to:
  • Use the Agile methodology to manage projects
  • Assess risk at the requirements level
  • Accelerate the approval process with automated routing and e-Signatures
  • Provide concise time-stamped audit trails
• The Quality team is able to:
  • Ensure that templates are available and used properly
  • Achieve data integrity according to the principles of ALCOA
  • Employ automated controls to enforce standard operating procedures (SOPs)
  • Eradicate illegible handwriting in forms and documentation
• The IT team is able to:
  • Manage IT changes to reduce incidents and meet regulatory requirements
  • Simplify system management with standardized activities on a single platform
  • Safeguard processes and sensitive information
  • Develop and implement backup, disaster recovery, and business continuity plans
  • Gather and evaluate data for company decision-makers
• The Senior Leadership team is able to:
  • Avoid observations and warning letters during audits
  • Reallocate staff, resources, and budget to value-added activities
  • Accelerate your organization’s speed to market
  • Trust that products and processes adhere to regulatory requirements

How do you make all of this possible in your life sciences organization? ProcessX.

By digitizing and automating the validation and compliance process, Quality and IT teams mitigate risk and maintain audit-ready records by performing system risk assessments and tracking validation efforts at the system level. As your single source of truth for validation and supporting documentation, ProcessX empowers your teams with more control and less risk.

Automation Reduces the Cost of Validation for Your Organization

VLM is part of application lifecycle management (ALM) in ProcessX. It encompasses user access management, periodic review, regulatory applicability assessments, and incident management, which is integrated with artificial intelligence (AI) and machine learning for activities like trends analysis and AI-enabled insights.

It incorporates automation that eliminates the need for paper-based processes and reduces the cost of validation for your organization.

ProcessX drives efficiency in:

• Creating and approving validation plans. Define the scope of the validation project. ProcessX helps you track resources assigned to the project, acceptance criteria, and deliverables. Next steps in the timeline are available only after previous steps are completed to ensure that requirements are met.
• Maintaining a traceability matrix. Consolidate validation assets and records into one system. ProcessX makes it easy to establish and maintain relationships between requirements and test cases, especially in response to changes and regression testing.
• Managing your risk-based approach. Use the risk-based Computer Software Assurance (CSA) methodology, which can be built into the ProcessX validation process. After a change control process is initiated, validation deliverables are generated and a risk assessment is performed on the requirements according to the testing approach.
• Test Automation: leveraging our integrated test automation massively speeds up releases and allows for 100% regression testing.
• Sustaining a validated state. Automate testing to simplify release management and eliminate deviations. Cloud Assurance as a Platform integrates with the VLM workflow in ProcessX and uses starting point scripts to implement automated testing.
• Preparing for regulatory audits. Choose ProcessX as your end-to-end solution that provides a system of record for evidence, supports regulatory audits, and complies with U.S. Food and Drug Administration (FDA) 21 CFR Part 11 and other global regulations.

CSA, CAaaP, and ProcessX

Since the FDA’s CSA guidance was released in September 2022, life sciences organizations are encouraged to use its risk-based approach for Computer System Validation (CSV). CSA gets you away from manual, paper-driven, and resource-intensive processes. It prevents excessive testing and documentation, shortens cycle times, and lets you focus on patient safety, product quality, and data integrity.

CSA decreases validation documentation time and accelerates your return on investment (ROI). When you streamline validation and maintenance, you make your teams more efficient and get products to patients faster.

USDM manages validation of release for many software vendors (Veeva, SAP, Oracle, Salesforce, AWS/Azure/Google, and many more).   These pre-packaged validation IP built with automated testing gets loaded into the VLM and gets customers a quick start to building for their specific intended use.  This offering, Cloud Assurance as a Platform automates the validation and testing of applications and software by leveraging USDM’s deep domain knowledge to validate, manage, and optimize GxP applications.

When paired with ProcessX VLM, you’re able to:

• Speed your time to market
• Maintain a perpetual state of audit readiness
• Lower your IT cost of ownership
• Enable AI and machine learning tools in your processes
• Harmonize your approach to digital quality

Don’t Let Validation be a Barrier to Innovation

If you’re still using spreadsheets and emails for your regulated GxP processes, then you’re putting your organization at risk. Automate these processes and increase efficiency using ProcessX and Cloud Assurance as a Platform. Together, they empower your digital teams to use automation to assess risk, enforce system policies, and document changes to the system.

Regulations are no longer a barrier to innovation in your organization. You’re able to implement new workflows and gain valuable insight from your data to drive better business decisions.

The flexible ProcessX platform equips your teams to add and automate workflows using rule-based decision-making. It’s all done with clicks, not coding. Guesswork and human error are replaced by the ProcessX advantage. Contact us for a demo and to learn why ProcessX is your solution for automating validation lifecycle management.

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