Validation

Software validation is a critical process for laboratory facilities, ensuring that your solution meets specific requirements and fulfills its intended purpose. Proper validation saves time and money by identifying and correcting potential flaws or unexpected behavior prior to utilizing the software in a real production setting. It also helps to increase process efficiency and lays the groundwork for meeting regulatory compliance. Though the validation process may seem daunting, especially to smaller labs and offices, RURO’s ISO 9001 certified team provides comprehensive validation services to guide your facility through the process. Ensure your project is completed on time, on budget, and to your specifications with RURO’s expert assistance.

RURO validation services are built around your facility’s needs and includes the creation of project plans, gap analyses, testing plans, protocols and reports, formal testing documentation, and more. We will collaborate closely with you before and during the validation process to keep your requirements and expectations the top priority in the design of your software, while also ensuring its overall functionality. Contact us for more information on RURO validation services.

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RURO’s Validation Process:

User Requirements & Specification Documents

In collaboration with your end users, RURO creates a user requirements document that contains a list identifying the functionality that is required for your software. Your validation team should work
together to discuss what functionality you require, with guidance from RURO as needed. RURO will also assist your team in creating a functional specifications document that is an extension of the user requirements, but with more detailed information.

Project Plan

When creating the project plan, RURO and your project team will identify who, what, where, and when
the validation will occur. A validation team will oversee the entire process, which typically includes the
project manager, technical lead, quality assurance lead, validation lead, and a support lead. RURO will create a Configuration Design Specification that describes how the system meets your requirements.

Installation Protocol & Report

The installation protocol document outlines how the software should be installed. The document may
also include hardware specifications and installation instructions. The Installation Report serves as
evidence that the software was installed correctly.

Testing Protocol & Reports

The testing protocol document outlines the specific objectives, procedures, data sets, test scenarios, expected results and acceptance criteria for the system acceptance testing (SAT) process. These
protocols will test the software components your company will utilize, and RURO will then create a
detailed report that includes a summary of the test execution, addressing adherence to procedures, acceptability of results, as well as any unexpected results. Testing results are summarized in a Testing Report.

System Release & Completion

By the time of system release, the users have been trained, data has been entered, and business
scenarios have been completed. The users can now begin using the software, but beyond this, RURO validation will ensure that your system is maintained in a validated state, with standard operating procedures in place for controlling problems, change control, record retirement, and other
eventualities.


 

Interested In RURO Solutions?

If you think compliance services from RURO are right for your facility, contact us for more information!