Speed up your IT & QA
processes with DevValOps!

Getting compliance feedback and delivering validated computerized systems has never been easier!

What is DevValOps?

DevValOps efficiently supports computerized systems validation. It is a unique approach that combines in one role competencies from three different areas: development, validation, and maintenance.  

DevValOps is a bridge between developers and validators, it automates processes and communication, allowing to work in agile and waterfall on every stage of software development. 

 

Advantages of DevValOps

Faster time to market in GxP software development

Automated testing and reporting and better quality control,
100% compliance

Minimize documentation and processes with regulatory compliance

Reduced costs due to the elimination of laborious manual work

Smoother onboarding of new team members (IT, QA)

Agile form of documentation aligned with GAMP5 guideline

Key features of DevValOps tool

Track validation in native IT tools, ex. Azure DevOps

Continuous quality feedback to IT teams in native IT tools

Native IT tools as a single source of truth to track IT and validation processes

Conforms to agile methodologies of modern teams

Track tests performed by team testers

Out of the box Traceability Matrix from code to Validation Report

Validation Report generated automatically based on system records

Simple and intuitive deviation reporting

Intended use is defined as a User Stories

Continuous Delivery Integration - maintained a validated state

Read more about DevValOps

DevValOps bridges the gap between development, validation, and maintenance teams. It’s a one-stop solution that automates processes and communication, allowing you to work seamlessly across various methodologies, including agile and waterfall, throughout the entire software development lifecycle.

  • Effortless Status Tracking: Say goodbye to juggling multiple tools! DevValOps provides a centralized view of your validation progress, both within DevValOps and your familiar IT environment, like Azure DevOps. No more switching between platforms or struggling to consolidate information. DevValOps gives you a holistic view of the validation process at a glance.

  • Guided FMEA Risk Assessments: Our intuitive interface walks you through the FMEA risk assessment process, ensuring no crucial step is missed. FMEAs can be complex and time-consuming, but DevValOps simplifies the process by providing step-by-step guidance. You can be confident that you’ve identified all potential risks and established appropriate mitigation strategies.

  • Simplified Deviation Reporting: Identify and address deviations directly from requirements, mitigations, or tests. No more time-consuming paperwork! DevValOps streamlines deviation reporting by allowing you to easily document and record any issues that arise directly within the context of the specific requirement, mitigation, or test. This saves time and ensures all relevant details are captured for efficient resolution.
  • Automated Task and Test Creation: Mitigations arising from risk assessments are automatically transformed into tasks and tests within your IT tool, streamlining the remediation process. DevValOps eliminates the need for manual data entry by automatically translating identified risks into actionable tasks and tests within your existing IT environment. This ensures that corrective actions are implemented promptly and efficiently.

  • Real-Time Change Auditing: DevValOps keeps a meticulous record of all changes made within your IT environment, ensuring complete transparency. Maintaining complete audit trails is crucial for regulatory compliance in GxP environments. DevValOps automatically tracks all changes made to your IT system, providing a detailed record for auditors and ensuring a clear understanding of how the system evolved over time.

  • Automatic Test Linking: Tests conducted by your IT team are automatically linked to the corresponding requirements, eliminating manual data entry. DevValOps eliminates the tedious task of manually linking tests to requirements. By automatically establishing these linkages, DevValOps ensures traceability and simplifies compliance demonstrations.
  • Flexible Release Management: DevValOps caters to diverse project methodologies. Whether you favor waterfall, scrum, or kanban, our release concept adapts to your production deployment needs. DevValOps is flexible enough to accommodate your specific development workflow. Whether you work in a traditional waterfall environment, utilize agile methodologies like scrum, or leverage the kanban approach, DevValOps seamlessly integrates with your chosen project management style.

  • Out-of-the-Box Traceability Matrix: Gain a holistic view of how everything connects. DevValOps automatically tracks all elements, providing a comprehensive traceability matrix without any additional setup. Traceability matrices are essential for demonstrating compliance in GxP environments. DevValOps eliminates the need to manually create and maintain these matrices by automatically tracking the relationships between requirements, risks, mitigations, tests, and other validation artifacts.

  • Downloadable Validation Reports: All data is meticulously recorded and readily available for download in a comprehensive validation report format. DevValOps saves you time and effort by compiling all validation data into comprehensive reports that can be easily downloaded and shared with auditors or other stakeholders. These reports provide a complete picture of the validation process and serve as auditable documentation of your compliance efforts.

DevValOps empowers your teams to achieve faster time to market, ensure regulatory compliance, and reduce costs associated with manual validation tasks. With improved quality control, smoother onboarding, and seamless IT-Quality collaboration, DevValOps is the key to a more efficient and effective GxP software development process.

Contact us to learn more about quality system implementation services.

With eCValidation you will easily meet regulatory requirements.