Labguru Validated Cloud
Ensuring GxP Compliance at the Highest Level With a Continuously Validated Cloud Environment
Labguru offers a continuous validation model for customers who require a higher level of compliance and data integrity, implementing quality assurance, good manufacturing practices, quality control, and quality risk management. We prevent any loss, manipulation, or inaccuracy of data in your research management system by assessing the risks that might be caused by each action in the system and conducting thorough tests on each change to the system.
The perfect Plan for You!
Labguru offers two installation options, enabling you to select the plan most fitting to your needs:
1. Dedicated Single Tenant Instance ("Private Cloud")
Customers who require a higher level of security options or configuration can get a dedicated Validated Labguru instance (private cloud). You will be able to adjust the validation plan to your requirements and will have access to a test environment for PQ testing purposes.
2. Multi-tenant Instance ("Public Cloud")
Customers can also opt for a shared cloud platform, a package that includes a fixed number of version updates per year, scheduled by Biodata. Customers will be notified in advance on upcoming updates and will have access to a test environment for PQ testing purposes.
What Does The Labguru Validated Cloud Package Include?
1. Validation Plan: A plan covering the initial delivery project of a validated Labguru environment, as well as the terms for maintaining and continuing the validation of the environment.
2. Validation Summary Report (VSR): A report summarizing all changes made in Labguru since the previous report, focusing on approval (and re-evaluation if required) of the development and testing documents).
3. Functional Requirement Specification (FRS): A document describing the operations and activities the system must perform according to the customer's needs.
4. Master Risk Assessment: An overall assessment of the possible impacts caused by the system requirements and the methods that will be used to mitigate these impacts.
Validated Development Lifecycle
The development lifecycle of Validated Labguru includes several key steps as described below. The proper execution of these steps is maintained and supervised by our Validation Management Team:
Before development starts, the impact of each change is assessed. The impact assessment serves as the guideline for new test protocols and is a key component in the decision whether the FRS and MSA are to be updated when creating a new version.
Labguru development at Biodata adheres to the industry-wide accepted standards for developing web applications, including industry standards for graphical user interfaces (GUIs). Additionally, our code development adheres to the guidelines for software development per Biodata's internal protocols and practices as documented in Biodata’s QMS.
The quality assurance (QA) and testing procedures in Labguru are based on a scaled agile framework. Any changes to Labguru are released only after thorough manual and automated testing efforts. The tests are done throughout the different phases of development to verify the new feature enhancement produces the expected results and does not cause regression with existing functions in the application or affect its performance.
Issues Tracking and Resolution
All issues found throughout the validation life cycle are recorded and managed in specialized software and tracked from creation to resolution. The impact of each issue resolution (bug fix) is assessed and then tested and approved in the testing phase. Bug fixes are then added to the period release versions where they are tested again as part of the release.
For each update of validated Labguru the Validation Management team assesses all changes introduced into Labguru since the previous update and performs the needed updates to Labguru’s FRS, MRA, and test protocols. A report is created to summarize the activity and to approve the validity of the new version. When a new version of Labguru is released, it is after thorough testing procedures that meet Labguru's high standard of quality, reliability, and traceability.
End-User Independent Validation
In addition to validation performed within Biodata, the customer's responsibility is to devise and perform PQ validation based on the organization's QMS, to verify that the informatics software complies with the intended use.