Validated Cloud

Labguru Validated Cloud is a continuously validated cloud environment designed for life sciences organizations that require the highest level of GxP compliance, data integrity, and quality assurance. Offered by Biodata, Labguru combines a digital lab notebook, LIMS, and informatics software into a single compliant, cloud-based platform — covering everything from protocols and experimental data to lab management records. The Validated Cloud package is purpose-built to support good manufacturing practices, quality control, and quality risk management by rigorously assessing risks associated with every system action and conducting thorough testing on every change.

Organizations can choose between two deployment models depending on their security and configuration requirements: a dedicated single-tenant private cloud instance or a shared multi-tenant public cloud instance, each with access to a test environment for Performance Qualification (PQ) testing purposes.

Deployment Options

• Dedicated Single Tenant Instance (Private Cloud): Customers requiring a higher level of security or custom configuration receive a dedicated validated Labguru instance. This option allows customers to adjust the validation plan to their specific requirements and includes access to a test environment for PQ testing.
• Multi-Tenant Instance (Public Cloud): A shared cloud platform that includes a fixed number of version updates per year, scheduled by Biodata. Customers are notified in advance of upcoming updates and also have access to a test environment for PQ testing purposes.

Validated Cloud Package Contents

• Validation Plan: A comprehensive plan covering the initial delivery of a validated Labguru environment, as well as the terms for maintaining and continuing the validation of that environment over time.
• Validation Summary Report (VSR): A report summarizing all changes made in Labguru since the previous report, with a focus on approval and re-evaluation of development and testing documents.
• Functional Requirement Specification (FRS): A document describing the operations and activities the system must perform in accordance with the customer's specific needs.
• Master Risk Assessment (MRA): An overall assessment of the possible impacts caused by system requirements, along with the methods that will be used to mitigate those impacts.

Validated Development Lifecycle

1. Impact Assessment: Each change to the system is evaluated to assess its potential impact, ensuring risks are identified and addressed before development proceeds.
2. Development: Labguru development at Biodata adheres to industry-wide accepted standards for web application development, including standards for graphical user interfaces (GUIs). Code development follows Biodata's internal protocols and practices as documented in Biodata's Quality Management System (QMS).
3. Testing: Quality assurance and testing procedures are based on a scaled agile framework. All changes are released only after thorough manual and automated testing across different phases of development, verifying that new features produce expected results and do not cause regression with existing functions or affect application performance.
4. Issues Tracking and Resolution: All issues identified throughout the validation lifecycle are recorded and managed in specialized software, tracked from creation to resolution. The impact of each bug fix is assessed, tested, and approved before being incorporated into periodic release versions, where they are tested again as part of the release process.
5. Updates Management: For each update, the Validation Management Team assesses all changes introduced since the previous update and performs the necessary updates to the FRS, MRA, and test protocols. A summary report is created to approve the validity of each new version, ensuring every release meets Labguru's standards for quality, reliability, and traceability.

End-User Independent Validation

• In addition to validation performed within Biodata, customers are responsible for devising and performing their own PQ validation based on their organization's QMS, verifying that the informatics software complies with its intended use.

The entire validated development lifecycle is maintained and supervised by Labguru's dedicated Validation Management Team, ensuring continuous compliance and personalized validation plans that bring GxP compliance to the highest level for regulated life sciences environments.