Validation Support

Our approach to validation is built on a shared responsibility model, ensuring that both our team and customers play a role in maintaining compliance and system integrity.

We are responsible for ensuring that the LabHQ software is developed, tested and released under a robust quality management framework, meeting all applicable regulatory and technical standards, including:

• Managing the full software development lifecycle, from design through to deployment.
• Performing comprehensive functional and regression testing.
• Providing documentation and evidence to support customer validation.

Our customers are responsible for validating the system for its intended use within their specific operational and regulatory context, including:

• Executing user acceptance testing (UAT) and verifying workflows that are unique to their environment.
• Maintaining internal validation records and procedures in line with their quality system.

This collaborative approach ensures that LabHQ remains fit for purpose, compliant and reliable.

Software Updates

LabHQ follows a structured quarterly update process, ensuring that users receive regular and predictable software updates with new features, improvements and defect fixes every quarter.

Dedicated Validation Environment

To support controlled adoption of software updates, we provide users with a dedicated, independent validation environment which sits alongside their day-to-day production environment. The validation environment allows your team to:

• Preview and test upcoming functionality before it is deployed to production.
• Evaluate features and fixes in a safe, isolated setting.
• Plan and execute validation tasks without impacting daily operations.

Update Planning & Communication

At the beginning of each quarter, we publish a proposed change summary on our support website that outlines the planned updates for the upcoming release. This summary includes:

• A detailed list of planned features and improvements.
• Key milestone dates, including the start date of the validation phase and the target go live date in production.

Before the validation phase begins, a final change list is issued to confirm the exact updates included in the release. This ensures full transparency and allows users time to prepare for validation and internal testing.

Test Certification

To further support customer validation efforts, each quarterly release is accompanied by a comprehensive test certificate. This includes:

• The results of our automated regression test suite.
• A summary of all test scenarios executed.
• Confirmation that all tests successfully passed.

The test certificate is designed to streamline internal validation requirements of the customer by minimising the need for redundant manual testing during user acceptance testing (UAT), allowing your team to concentrate on business-critical and higher-risk areas.

Regulatory Alignment

LabHQ is designed to align with global regulatory expectations for electronic systems used in laboratory and manufacturing environments, enabling our customers to maintain compliance with GxP and ISO requirements.

LabHQ provides functionality that supports compliance with:

• FDA 21 CFR Part 11 - Electronic Records and Electronic Signatures.
• ISO 17025 - General requirements for the competence of testing and calibration laboratories.

LabHQ incorporates built-in features to assist compliance, including:

• Secure user authentication and permission-based access control.
• Comprehensive audit trails for data creation, updates and deletions.
• Electronic signatures and approval workflows.