Data traceability is an important aspect of every laboratory’s workflow — even if you’re not in an environment that’s regulated by 21 CFR Part 11. The truth is, data traceability is not only relevant for labs that need to meet regulatory compliance; it’s also important for ensuring labs have complete confidence in their data integrity. Here’s how the Thermo Scientific™ Qtegra™ Intelligent Scientific Data Solution (ISDS) software can help your lab gain that assurance, regardless of the challenges you face.
Our lab has a lot of staff turnover. How does Qtegra ISDS Software help us ensure data integrity?
Many labs experience frequent staff turnover, which means there are many different users with different levels of knowledge. Qtegra ISDS Software enables your lab to easily track who, when and how different users touched data.
Our lab is in a CFR regulated environment. How does Qtegra ISDS Software help us stay compliant?
It provides a wide range of features that enable laboratories to operate within total compliance, not only with respect to 21 CFR Part 11, but also other compliance guidelines applicable in different regions.
Our lab struggles with user access control. What features does Qtegra ISDS Software offer to help with that?
It offers user access control levels for up to seven different user groups. These can be removed or renamed by the customer to fit with existing SOPs. In addition, you can control password length, complexity, history and duration of validity. Furthermore, any changes in user access management are captured in the system. Activities such as log on, log off, and granting or denying of access, are all captured in the audit trail. A comprehensive report of changes can be displayed on screen in Qtegra ISDS Software or exported in a human readable form for independent review.
Our lab is concerned about data integrity and security. How does Qtegra help?
With Qtegra ISDS Software, LabBook data files can be locked using e-signatures to disable any further data manipulation and data export or reporting. In addition, all Qtegra ISDS Software related data files can be backed up using standard Windows compatible backup applications, and any changes in the e-record (the LabBook) are captured in the audit trail. With every change in the record, a new data version is generated with date and time, user identification and reason for change. Version-to-version changes can be compared and captured in human readable reports for review.
Our lab requires a strict audit trail for our analysis. How does Qtegra ISDS Software ensure data integrity?
With Qtegra ISDS Software, the audit trail captures every change made to the method and any effect on analytical data. Furthermore, the audit trail functionality is always on. It cannot be disabled, which means you rest assured.
Qtegra ISDS Learning Page and Videos:
Qtegra ISDS Smart Note:
Smart Note 000204 – How does Qtegra ISDS Software for gas IRMS support a 21 CFR Part 11 compliant environment?