At-a-Glance:

  • In-flight data is vulnerable, especially where instruments and systems require manual action.
  • The monitoring system built into Scitara Digital Lab Exchange DLX™ ensures every data transaction in the lab is captured and made available for further analysis and decision making
  • Monitoring is a key component of DLX.
  • Full real-time visualization of digital transactional activity
  • Monitoring is achieved through an immutable audit trail and event stream log as part of a transformative process, as well as real-time monitoring features for tracking Orchestrations in progress.

In a pharmaceutical research environment where the result may be a life-saving drug, the laboratory processes should include compliance, data integrity, and end-to-end monitoring of all laboratory processes with a clear chain of custody as data moves through those processes. In the pharmaceutical industry, data integrity is of paramount importance. Ultimately, a rigorous monitoring protocol helps to ensure safety as well as efficiency. To ensure the integrity of not just the data and the process, but the resulting therapeutic treatments, the laboratory process must ensure that data is accurate, and minimize risk of it being compromised by procedural or human error.

A typical pharmaceutical lab may include multiple instruments and laboratory software installations. The ability to capture a full digital trail of the data as it flows between the various endpoints provides both tools and assurance that data integrity is maintained and provides the ability for researchers to reconstruct workflows as needed.

DLX incorporates monitoring as one of its key components. As laboratory data moves through DLX’s automated process. The built-in Audit Trail and Event Stream monitors the end-to-end data stream throughout the entire automated workflow, recording data as it moves between instruments and software regardless of vendor origin – even including legacy devices, so that no data are left behind.

Monitoring Limitations in the Traditional Laboratory

Deviations sometimes occur in the pharmaceutical QC laboratory because instructions or standard operating procedures were not followed, or where a test result is out of limits. When deviations occur, the laboratory typically responds by initiating a Corrective and Preventive Action (CAPA) plan which addresses the root cause of the deviation. Where the root cause of those deviations is from the use of legacy equipment, manual processes, and a lack of data integrity, the solution should lie in going beyond mere procedural improvements to embrace a transformative process of automating the flow of data between those instruments and systems.

Scitara Monitoring and Compliance

The DLX platform provides the technical controls necessary to support compliance in a regulated environment, including an immutable audit trail and event stream log, role-based access controls, 21 CFR Part 11 compliant eSignatures, and reason-for-change input. Incorporating DLX is an appropriate and effective response to readily address the operational and technical changes necessary to overcome errors resulting from manual processes, deviations, resistance to change, and limitations which occur because of unconnected legacy instrumentation.

Scitara’s monitoring capabilities support data integrity, compliance, and the digital transformation that is fast becoming part of the modern laboratory. Through the DLX Web Console these other monitoring features are included:

  • The Connections view: Displays a list of available Connections and their status
  • The Orchestration view: Displays a list of available Orchestrations, and execution history, including real-time monitoring of Orchestrations in process
  • The Event Stream view: A contextualized log of data captured through Orchestration execution and manual Connection events
  • The Audit Trail view: An audit trail of changes to user parameters and settings within the Scitara DLX platform

Together, the Audit Trail and Event Stream provide a full transaction history. The DLX Event Stream provides a detailed log of data exchange. Events, Actions, data captured and posted, as well as all function transform activity is captured within the event stream and can be searched and reconstructed as needed. This supports digital data integrity for data in flight as well as compliance. Data is clearly tracked from when it was first captured by DLX, function transform activity is logged and the results captured in the Event Stream as well as the data posting at its target destination.

The DLX Audit trail provides a log of user-generated activity within DLX. User logins and changes to DLX configuration parameters are tracked here. The Audit trail may be filtered by User, event kind, or date range.

While the current generation of laboratory products and tools may meet compliance requirements, they may still fall short in meeting data integrity needs. A modern laboratory requires a stronger system, and indeed a digital transformation, which sustains data integrity, incorporates automation, and builds in a robust system of monitoring and reporting which support compliance. The potential of this connected approach to enable faster and more accurate decision-making in the drug discovery and development process, and so bring new drugs to market more quickly, is recognized across the pharmaceutical industry.

For Further Reference:

Data Integrity and Compliance for Scientific Data in Flight