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and incorporate sophisticated algorithms that can perform userdefined tasks such as dilutions or reinjections to obtain highquality chromatograms first time around. Advanced systems, such as Thermo Scientific Chromeleon CDS Software, can even automate the integration of chromatogram peaks, further enhancing the consistency and reliability of data. Storing chromatography information centrally can also help teams work more efficiently by maintaining a single version of the data, eliminating the inconsistencies that can be introduced if multiple versions of files are used. CDS solutions that facilitate centralised storage also allow data to be securely accessed by colleagues wherever they are, allowing them, for instance, to initiate and check on sequences remotely. With easy access to the latest chromatography data at the click of a button, results can be shared faster, helping teams make decisions around manufacturing and batch release more quickly and, ultimately, accelerating the delivery of therapeutics. The increased complexity and footprint of modern pharmaceutical manufacturing processes means regulators are putting an increased focus on the traceability and transparency of the data associated with chromatography workflows. Regulations such as U.S. FDA Title 21 CFR Part 11 and UK MHRA ‘GXP’ Data Integrity Guidance and Definitions require pharmaceutical manufacturers to ensure traceability from measurement to reporting. For large organisations with multiple moving parts, maintaining full accountability across the manufacturing chain can be challenging; demonstrating compliance in the event of an audit even more so.
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The latest CDS software solutions make it straightforward for pharmaceutical manufacturers to achieve end-to-end oversight of chromatography workflows and avoid the complexities associated with harmonising audit trail information when fragmented solutions are used. Most CDS solutions will store a complete history of interactions with the system. However, some of the more advanced CDS solutions offer powerful audit trail functionality to enable users to quickly and easily search and review events in order to help detect unusual or non-compliant user behaviour. Some platforms, like Chromeleon CDS, allow all events to be easily key-word searched and filtered based on action, and even allow audit trails to be added to reports for review. With the right tools to support complete workflow transparency right across the manufacturing chain, businesses can reduce time searching and focus more on innovation. Chromatography workflows play a central role in pharmaceutical production processes and manufacturers need effective solutions that make managing, accessing and sharing this information between teams seamless, secure and regulatorycompliant. The latest CDS software solutions are helping to maintain the highest standards of data integrity to help the pharmaceutical industry accelerate the manufacture of safe and effective medicines for patients.
While dispersed manufacturing chains can result in reduced operational costs and shorter times for products reaching end-users, they can unintentionally lead to poorly harmonised processes and inconsistencies in data.