How to Address Data Integrity Challenges

Data integrity continues to be a hot topic for regulatory agencies in the pharmaceutical industry. Companies are making tremendous efforts to ensure their data integrity capabilities are robust and unified across multiple laboratories and locations.

We recently hosted a webinar, where Brian Alliston, Data Integrity Expert and CDS Specialist at Sterling Pharma Solutions shared the company’s experience of replacing their chromatography data systems (CDS), to ultimately improve compliance and general cohesion of processes across the company. Compatibility with existing instrumentation is a huge factor to consider when choosing a data integrity solution. Sterling Pharma have implemented their new system, Chromeleon™, which now spans multiple laboratories.

To learn more about how Chromeleon can help demonstrate regulatory compliance and overcome CDS data integrity challenges, we spoke to two experts at Thermo Fisher Scientific; Darren Barrington-Light, Senior Manager, Product Marketing, Chromatography and Mass Spectrometry Software; and Shaun Quinn, Marketing Manager, Compliance, Chromatography and Mass Spectrometry Software.

Laura Mason (LM): There is an ever-increasing focus on data integrity by international regulatory agencies, how has this affected regulated companies, and more specifically, their operation?

All regulated companies are having to look again at whether or not they have the necessary controls in place across all of their processes to ensure data integrity. One aspect of this is ensuring that technical controls are correctly implemented and managed and identifying any vulnerable points that could be exploited. For example, are there procedural controls that were set in place due to past deficiencies that may be subject to human error but could now be remedied with a more secure technical control. In general, regulated companies are looking towards technical solutions to automate many of their process activities, an example being having a so called ‘paperless lab’.   

LM: Why is it important to understand and review audit trails?

An audit trail provides answers in the form of a documented history to questions revolving around a particular event. Regulators talk about audit trails as a means to ‘reconstruct’ the history of regulated companies good manufacturing practice (GMP) activities. It is in the interests of regulated companies to conduct proper reviews of audit trails because in so doing so, they can identify possible situations where data can be compromised and then investigate, and if need be, improve their processes. Through effective audit trail review, regulated companies can ensure the completeness and reliability of their data and in effect use it as a basis to demonstrate that the information they submit is trustworthy.

LM: What are the implications of adopting a CDS system which has only limited compatibility with existing instrumentation and that cannot be applied to multiple laboratories?

Having limited compatibility with existing instrumentation would mean a potential significant investment in new hardware or risk leaving instruments and therefore data outside of the CDS system. Having a CDS that offers multi-vendor control for a wide range of instruments ensures that all chromatographic data can be captured and controlled by the CDS alongside giving freedom of choice for future equipment, allowing the best instrument to be selected for the task.

The importance of having a CDS that can expand to incorporate multiple sites is that it allows all data to be kept in a common location and format, and ensures that data integrity practices are the same everywhere. This simplifies demonstrating compliance to regulatory bodies and enables easy data transfer between sites.

LM: The Chromeleon™ Chromatography Data System (CDS) allows users to unite laboratories and improve efficiency, what features enable this cohesive functionality?

Chromeleon can scale from workstation to global enterprise without the need to reinstall or relicense. Its expandable architecture allows laboratories and sites to be added as your company grows. Of course, with the use of centralized resources in a network the risk of losing data due to an outage is always present. Chromeleon handles this with its industry-leading network failure protection system that ensures 24/7 up-time for the lab with all data in progress at the time of the outage available for processing and reporting and even allowing new runs to be started, keeping the lab running.

Running with a centralized data repository using a relational database (either Oracle or SQL Server) ensures the highest levels of data security while allowing easy searching and retrieval of data.

Key productivity features of Chromeleon include:

• Smart features such as eWorkflows, dynamic data linking and SmartLInk provide proven productivity gains compared to competitor systems. 
• eWorkflows are the easiest and fastest way to ensure correct sequence creation for any analysis. They provide a framework that ensures SOPs are followed during sequence creation while saving huge amounts of time. 
• Dynamic data linking significantly reduces post-run processing effort by ensuring any changes made are instantly reflected in the results. 
• SmartLInk reduces reviewing time by intelligently giving the analyst all the relevant information they need on the screen enabling fast reviewing of data and audit trails. 

LM: Could you highlight the importance of data completeness? What are the potential consequences of being unable to demonstrate that you are reporting complete data sets?

Having complete data is critical to being able to tell the complete ‘story’ of the data. Any gaps in the story will be considered areas of suspect activity by any auditor. Having all data in one CDS in a centralized location ensures that all data is complete and maintained for the lifecycle of the data.

Chromeleon uses a sequence based model and as such all the data relating to the injections in a sequence are contained in that sequence. This makes it very easy to find all related audit information and therefore demonstrate compliance.

The biggest potential consequence of not having complete data and reporting complete data sets is that you fail an audit and potentially cannot ship your finished products costing your company a lot of money.

LM: How can Chromeleon™ Chromatography Data System (CDS) software be used to demonstrate compliance and control of data?

Our whitepaper describes exactly how Chromeleon software can be used to demonstrate compliance and data control.

Our recent webinar, now available on-demand, also discusses the features of Chromeleon. Part 2 of this webinar series will cover the use of eWorkflow and templates to improve efficiency and compliance, and is scheduled for March 14.

Darren Barrington-Light and Shaun Quinn were speaking to Laura Elizabeth Mason, Science Writer for Technology Networks.