Ensuring data integrity is an essential component of the biopharmaceutical industry’s responsibility to guarantee the safety, efficacy, and quality of therapeutics, and of FDA’s ability to protect public health. The FDA defines data integrity as the completeness, consistency, and accuracy of data. “Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).”¹

Data integrity must be maintained over its entire life-cycle and is an important aspect in the design, implementation and usage of any system that stores, processes or retrieves data. The overall objective is to ensure that data is recorded as intended, preserved, and remains intact throughout the process, preventing unintentional changes to the information as it was originally recorded. When the integrity of data is secure, the information stored in a database will remain complete, accurate, and reliable regardless of how long it’s stored or how often it’s accessed.

Whenever data is replicated or transferred, the opportunity exists for data integrity to be compromised. Error checking protocols and validation procedures are typically utilized to ensure the integrity of data that is transferred or reproduced to verify that it remained intact and unaltered throughout the process. But what about data ‘in flight’? With digital transformation being a key initiative in nearly all scientific laboratories today, maintaining data integrity for data in flight is quickly becoming an area of focus for regulatory compliance measures.

Event Stream Monitoring and Digital Compliance

The development and widespread use of novel biological therapeutics and vaccines is emerging as the new standard for precision medicine and the treatment or prevention of disease. With the mainstream production of biotherapeutics, it is imperative to establish a well-defined regulatory framework throughout the biopharmaceutical development life cycle. The traditional scientific laboratory has implemented a wide range of rules and processes that govern how data is entered, stored, transferred and validated. With the current drive towards biological based processes, the automation of workflows, and the need for immediate access to real time data, the issue of data integrity for data in flight is rapidly emerging as a top area of concern surrounding regulatory compliance.

To facilitate data integrity, a digital trail must be captured and documented throughout the entire data stream. Within the biological development platform in particular, there are numerous stages of the process that necessitate interim intervention or decision points that require accessing and possibly “re-shaping” data or events in flight. Legacy or not ‘fit-for-purpose’ informatics enterprises often do not have the underlying system architecture for efficiently tracking the resulting data changes..

The Scitara Digital Lab Exchange (DLX)™ cloud platform brings this process into the 21st century, addressing the unique needs of the biopharmaceutical laboratory. From cell line development through upstream and downstream processing, Scitara’s DLX event driven Orchestrations maximize process integration, automation, and workflow efficiencies. Data in flight between instruments, applications or repositories are managed by Scitara DLX Orchestrations and become part of the event stream.

Connecting to streaming data systems as well as traditional analytical systems to apply calculations and logic for data in flight is now possible with Scitara DLX. This innovative platform allows you to create automated workflows that have gates for review and critical stage decision points while the data is on its way to its ultimate destination. All of this transactional information that flows through the system is captured and can be reconstructed at any time, providing a strong regulatory and data integrity position for data in flight.

Scitara DLX Orchestration and Event Stream Monitoring allows you to:

• Construct event driven lab workflows and multi-destination data flows
• Configure event driven data exchange between any connections
• Enable event driven notifications informing you of steps needing review or action by the lab team
• Connect to and interact with streaming data systems and non PC based instruments
• Add notes and a picture or video of the activity throughout the workflow
• Apply business logic and processing for data in flight
• Capture a complete digital transactional record in the Scitara DLX Event Stream that can be reconstructed as needed

Scitara DLX Orchestrated activities are tracked and logged in the Scitara DLX Event Stream, establishing a clear chain of custody as data is moved, merged or transformed. Data aggregation support is provided throughout the entire bioprocess. This allows reconstruction of complete workflows weeks, months or years after the fact and extends support for GxP compliant processes to data in flight.

Conclusion

The digital landscape of the biopharmaceutical laboratory is changing dramatically with the introduction of new technologies, applications and advanced AI/ML solutions. The resulting increasing complexity of data and regulatory compliance requirements challenges the status quo of workflow automation, data management and data integrity standards.

Digital transformation initiatives are bringing together siloed and disparate systems, allowing for the seamless connectivity of instrumentation and data, enabling workflow automation. The need for real time process interaction and monitoring in the biopharmaceutical laboratory presents unique challenges within the automation workflow. Innovative technologies such as the Scitara DLX platform provides the necessary tools and technology to enable this level of interaction with in-flight data.

“By providing, for the first time, a cloud-native platform for seamless data access and connectivity and easily configurable routine and complex workflows in a scientific laboratory, scientists can not only free up more time for science, but also leverage AI/ML techniques, data analytics, and decision-making tools, to more effectively develop life-saving therapies, novel biologics and vaccines.” – Ajit Nagral, CEO of Scitara.

Success in laboratory informatics projects can be difficult to achieve largely due to the complex processes and technologies utilized in laboratories, and the many different aspects of the workflow across the enterprise. With over 25 years of experience in laboratory informatics professional services, Astrix is uniquely positioned to drive the success of your digital transformation project and solve challenges in your lab.

Why It Matters for You

Combining the benefits of modern cloud-based architecture with a vendor-neutral peer-to-peer platform with robust security, compliance, and laboratory-specific functionality provides unprecedented insights into laboratory and scientific operations. Scitara DLX’s monitoring system further ensures every data transaction in the lab is captured, creating a trusted digital trail available for further analysis and decision making.

• Implementing Scitara Digital Lab Exchange (DLX) platform within your informatics enterprise will allow you to connect to streaming data systems to apply calculations and logic for data in flight while capturing that information in an audit trail.
• Eliminating manual transcription steps establishes an auditable chain of custody for simple instrument outputs through the use of Scitara DLX IoT enabled Orchestrations.
• Creating automated workflows through Scitara DLX provides secure in-process review gates and critical stage decision points while the data is on its way to its ultimate destination.
• Capturing transactional information that is flowing through the system allows it to be reconstructed at any time, providing a very strong regulatory and data integrity position.

About Astrix

Astrix partners with many of the industry leaders in the informatics space to offer state of the art solutions for all of your laboratory informatics needs.  With over 25 years of industry proven experience, Astrix has the informatics specialists and business process analysis tools required to develop and implement the solution that works best for your enterprise. Our domain experts have helped hundreds of companies globally effectively navigate their digital transformation journey, connecting people, processes and systems to accelerate the advancement of science and medicine.

References

¹Data Integrity and Compliance With Drug CGMP – Guidance for Industry, December 2018, www.fda.gov, accessed Mar 19, 2021.