Data integrity and accuracy are paramount in ensuring compliance with 21CFR#11 regulations, and they form the bedrock of the ALCOA+ Principles.
To aid organizations and laboratories in aligning with GxP guidelines, Labguru offers an enhanced tool for documenting the reasons behind changes made to experimental data within form.
Labguru provides users with a convenient and real-time documentation tool for specifying the reasons for changes. These documented reasons are seamlessly reflected in the audit trail, bolstering transparency and accountability.
Enabling Reason for Change:
For admins looking to activate the 'Reason for change' feature, the process is straightforward:
1.Navigate to the account settings.
2.Access the 'Advanced' tab.
2.Enable the 'Require reason for change' option.
Labguru's 'Reason for change' feature offers more than just compliance. Administrators can further customize the experience:
Reasons Management - Admins can select which reasons will be available to the users, either by selecting from a pre-existing list or by adding new reasons
Allowing User-Defined Reasons - Admins can select whether to permit users to record free-text explanations for changes:
Integration with Labguru's Form Element:
The 'Reason for change' feature seamlessly integrates with the form elements, a protocol-specific feature. These form elements are embedded at the protocol level and become populated within experiments. Users can effortlessly populate each field based on the settings defined at the protocol level, while ensuring that data changes are accurately documented.
Reason for change feature empowers organizations and labs to maintain data integrity, comply with regulations, and enhance transparency. By offering real-time documentation capabilities and customization options, Labguru ensures that data changes are not only accurately recorded, but also align with best practices and organizational needs.