CDS Audit Trail Reviews 101

If you’ve ever been tasked with reviewing CDS audit trails, chances are good that you understand the full meaning of the word “drudgery.”

An audit trail review (ATR) is typically a time-consuming, detail-oriented chore to ensure regulatory requirements have been met. It is performed by a second person, who checks to make sure the work has been performed correctly, no mistakes have been made, and the analysis has not been falsified. The review is focused on data integrity and must cover the whole of the analytical process: from sampling to the calculation of the reportable result.

ATR doesn’t have to be tedious

CDS audit trail review is an absolute requirement for keeping your lab audit-ready and continuously compliant. But new technologies and processes are available to speed up the ATR process, saving time, money, and sanity. By adhering to the following principles, you can accelerate ATR without compromising on accuracy, data integrity, or compliance:

  • Build it in, don’t bolt it on: Make sure audit trail capabilities are an integral function in your CDS or lab informatics application. If it is an afterthought of system design, it will bog down your ATR process.
  • Use risk management to reduce work: Risk management applies not just in the validation of the system, but also during operation of the CDS. This should include audit trail review, but it often does not. Therefore, consider how to use risk management to cut review times for audit trail entries, utilizing any technical controls that can be implemented in the CDS application to reduce the amount and number of entries to review.
  • Review only the exceptions in any analytical run: Limiting manual edits such as manual baseline adjustment can significantly reduce audit activity. If no deletions are allowed in the CDS, then all you need to look for are the modifications or the exceptions to normal working of the system. For example, if all peaks are integrated automatically, you do not need to look at the audit trail entries for manual integration. Each peak integration shows if a baseline has been placed automatically or manually with the integration codes BB or Bb for example. In the former, both the start and end baselines have been determined by the system; in the latter case, the trailing baseline has been positioned by a chromatographer (a dauntingly slow process).

Harness these features in OpenLab CDS

The newest release of OpenLab CDS software has the technical controls to help speed the ATR process and protect electronic records. These functions, often overlooked in selection of a CDS, include:

Harness these features in OpenLab CDS

Figure 1.What an audit trail is not

  • Audit trail functionality covering the whole system: a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record.
  • An activity log that shows all interactions of users with the software—including instrument management, changes to user roles and privileges, processing parameters and results.
  • Flexible metadata storage and search to separate active data projects from inactive or archived ones.
  • Configuration at the application level to protect electronic records.
  • Configurable user roles or types to avoid conflicts of interest—for example, no user should have administration privileges.
  • Custom Calculator, which automatically computes unique values directly within the software, removing error-prone calculation steps and allowing you to meet the data integrity requirements of GxP regulations with less effort.
  • Technical controls within the audit trail to highlight data changes and deletions to facilitate the review process, as well as enable review by exception, plus the ability to create efficient search routines within an individual project or the whole database to identify data trends and inconsistencies.
  • Functionality within the CDS application to document that audit trail entries have been reviewed.

OpenLab CDS also includes features that help you expand data integrity assurance to multiple instruments and processes, further expediting the ATR process. Examples include:

  • Multi-vendor instrument control for Agilent and non-Agilent LC, GC, LC/MS single quadrupole, GC/MS single quadrupole systems.
  • Enhanced data analysis to speed data review and interpretation and perform basic and complex analysis to quickly identify key information.
  • Application-specific software add-ons that make it easy to extend functionality or add additional capabilities with software add-ons such as Sample Scheduler, MatchCompare, GPC, and ADFExport.
  • Scalable architecture that enables you to improve lab operations through better access to instruments and information with a networked laboratory system.
  • Automated software migration tools that simplify the process of preserving result sets, methods, and user and instrument information from ChemStation version B, OpenLab ChemStation, OpenLab EZChrom, and Galaxie CDS,
  • Automated qualification tool that allows you to perform software verification tasks to ensure your software is always operating as designed.

Transform ATR into ART.

To learn how to master the art of audit trail reviews, check out the related content below.

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