Trade error-prone, paper-based validation for a faster and more efficient process.
Paperless validation represents a significant shift in how life sciences organizations ensure that their GxP processes, systems, and equipment meet regulatory requirements and are fit for their intended use.
Why Switch to Paperless Validation?
Paperless validation aligns with Good Automated Manufacturing Practice (GAMP) guidelines, ensures compliance with regulatory requirements, and enhances operational efficiency. It simplifies and streamlines your efforts in data entry, document management, approval workflows, and record-keeping.
By eliminating paper-based records, you can reduce the time and resources needed to manage validation processes, which results in efficient project timelines and cost savings.
Here’s how:
- Modernized Document Management. Validation plans, protocols, test cases, and reports are created, stored, and managed electronically.
- Automated Workflows. Approval workflows, signatures, and document review processes are automated for quicker routing.
- Compliant e-Signatures. The paperless validation process complies with regulations like the U.S. Food and Drug Administration (FDA)’s 21 CFR Part 11 and the European Union’s Annex 11 for electronic signatures and records to ensure the same level of integrity and authenticity as paper-based documents.
- Data Integrity and Compliance. All actions in a paperless validation system are automatically logged (audit trails) to ensure better traceability and maintain data integrity.
- Real-Time Collaboration. Stakeholders can review validation documentation, which improves collaboration and reduces decision-making delays.
From Document-Heavy Activities to Streamlined Automation
Transitioning from document-heavy validation activities to an automated approach is easy with ProcessX. Its robust test automation engine cuts test execution cycles from weeks to minutes and you have access to test runs and validation cycle status in real time.
Your GxP systems stay continuously compliant because automated testing scripts are executed after every release and enhancement so your organization is always audit ready.
Paperless validation with ProcessX equips your organization to:
- Provide evidence of software functionality using data-driven validation artifacts.
- Reduce release management time with an automated testing platform.
- Automate impact assessments to better measure and evaluate changes in your organization.
- Use Computer Software Assurance (CSA) to minimize your documentation efforts.
- Integrate validation with your change management process to maintain compliance.
- Accelerate your business growth with digital quality.
Application and Validation Lifecycle Management with ProcessX
As part of application lifecycle management (ALM), validation lifecycle management (VLM) in ProcessX incorporates automation to transform and eliminate the need for paper-based processes. It optimizes those processes and reduces the cost of validation for your organization. You’re able to roll out GxP systems more efficiently and have real-time visibility into all your deployments.
ALM and VLM enable you to:
- Create and approve validation plans
- Maintain a traceability matrix
- Manage risk-based requirements
- Sustain a validated state
- Prepare for regulatory audits
- Establish a single source of truth
As a result, your Quality team has instant access to details for faster approvals and your critical GxP systems, processes, and data are continuously compliant. Moreover, you never promote or release a system before all necessary approvals are complete, thereby avoiding costly deviations.
Process Optimization for a Variety of Systems
Built by trusted industry experts, ProcessX supports paperless validation for a variety of systems, including:
- Enterprise GxP systems
- Analytical instrument systems
- Manufacturing equipment and software
- Automation systems
Download the white paper Apply the Power of Automation to GxP Systems to learn about end-to-end capabilities of an automation application.
Cloud Assurance for Vendor and Validation Management
ALM and VLM in ProcessX and the Cloud Assurance managed service from USDM serve up complete validation management, including automated testing and regression testing for applications and software.
After more than two decades of experience collaborating with key software vendors and platforms for life sciences organizations, USDM knows the ins and outs of managing the numerous releases of Software-as-a-Service (SaaS) vendors.
Cloud Assurance leverages USDM’s deep domain knowledge to validate, manage, and optimize GxP applications. Support for the validation, change management, and updates to automated scripts and requirements can be added as managed services.
Seamlessly integrating with ALM and VLM, Cloud Assurance manages initial implementation, enhancements, and upgrades for your GxP applications, including:
- Change Control
- Regulatory Applicability Assessments
- Risk Assessments
- Validation Deliverables and Artifacts
- GxP System Inventory
If your organization isn’t already paperless, ProcessX helps accelerate that journey. It’s time to reimagine your business workflows and achieve transformative outcomes for your business units.
USDM offers training that enables your citizen developers to quickly adapt to the low-code/no-code platform, and experience automated validation with continuous compliance built in.
Contact us today to get started.
