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Peter Zipfell is product marketing specialist, CMD Software, Thermo Fisher Scientific.
Integration of two separate chromatography data systems boosts workflow efficiency.
Modern chromatography laboratories are complex, where analysis can involve multiple users employing a variety of instruments to conduct an assortment of workflows. The one constant is the large volumes of data that will be generated from these processes, making the collection, organization, and archiving of such information essential.
A chromatography data system (CDS) will automate the collection of data, allowing analysts to perform tasks without having to manually manage datasets, reducing user-error and ensuring that the information is as robust as possible. An advanced CDS will also ensure that laboratory workflows and practices meet the strict regulatory standards that surround data integrity. Currently, chromatography labs must be able to provide relevant data trails for auditing while adhering to increasing regulations. Attempting to manually collect and report data without a robust system in place, however, can rapidly become complicated and open to error, requiring the use of advanced software systems in modern labs.
Sterling Pharma Solutions, a contract development and manufacturing organization (CMDO) providing process development and optimization services, commercial manufacture of APIs and advanced intermediates, and rapid-response small-scale manufacture for clinical trials, employs a range of chromatographic techniques when conducting drug development and manufacturing projects, including ultra-high performance liquid chromatography (UHPLC) and gas chromatography (GC). Previously, Sterling had two separate CDS platforms that were responsible for their quality control (QC) and R&D laboratories. In an arrangement that was inherently inefficient, the platforms were split into two separate buildings with no interconnection between systems and laboratories, requiring analysts to make a 10-minute walk between buildings to check their sequences. Due to a recent expansion, the company’s analytical setup was insufficient to process the amount of data being produced, and these old CDS platforms had become a hindrance to productivity.
To deal with this challenge, the company combined the two buildings into a single and all-encompassing CDS. “We wanted a single, integrated system that would allow all of our workforce to have access to the data we use to make key decisions”, says Brian Alliston, data integrity expert and CDS specialist at Sterling.
The company chose a single, centralized CDS that allowed the labs to share the use of instruments and data easily. Alliston explains that “the ability to monitor instruments from remote PCs is especially useful when the system you are using is in a different building to the one you are based in,” and by uniting both labs, “the data goes into a central location, so we can work systems from separate labs, and can see all of the data, all of the time. This saved us time and effort straight away.”
By integrating the complex operation of two separate laboratories into a single data management platform, the company was also able to increase throughput in many areas. The productivity around routine workflows increased overall and storing the methodologies for frequently used analytical sequences in a centralized database meant that workflows could be downloaded directly to the UHPLC or GC instruments.
Alliston states that “using a single CDS, our analysts are now able to create and initiate sequences straight from their desktops”, which frees valuable analytical time to be implemented elsewhere. Additionally, the integrated platform ensures that strict adherence to the standard operating procedures (SOPs) is enforced. “We’ve significantly minimized the potential for human error in sequence set-up,” says Alliston. As a result, methods do not need to be repeated as often because there is more observance of guidelines.
In the previous setup, only a small number of the company’s analysts had access to both CDS platforms, which meant that sharing data was an inconvenient and often time-consuming process. With the integrated platform, all users have access to the same software platform, meaning that chromatograms, data, and other method information can be quickly shared. This rapid distribution of information has led to faster report generation, enabling results to be reviewed in more depth. As Alliston describes, “we have training available for all the analysts. This is especially important for looking at all data audit trails continually as part of the review process.”
The need to safeguard the integrity of data is crucial; regulatory authorities are increasingly scrutinizing the accuracy and completeness of laboratory results. As Alliston says, “we get customer audits almost every week. Our data integrity is looked at on an almost daily basis, both externally and internally”.
To comply with these audits, the company wanted to ensure complete traceability from start-to-finish of every analysis, which required software that would log any changes made by the user, but that would also allow the rapid retrieval of relevant audit trails for any workflow. This was made possible with the integrated CDS, while analysts can also visualize the modifications and revert to the previous versions if necessary. These advances simplify the ability to demonstrate compliance with regulatory authorities, streamlining report generation and speeding up the data review process.
The ability of analysts to view their own audit trails is important for up-to-date chromatography labs. As Alliston explains, “in terms of data integrity, there’s been a change in what analysts are required to do. There’s now the requirement to look at the audit trails as part of the review process, and so analysts are having to become experts and interpreting these audit trails”. As such, it is important that a CDS has the ability to make this process as simple as possible.
One of Sterling’s goals was to move to a more efficient, paperless working environment, but their previous dual-CDS platform was unable to adhere to the latest data integrity standards in this way. “Although we routinely used electronic data before the upgrade, we were still reliant on paper copies as the primary data,” Alliston explains. Archiving these papers added further complexity and time to workflows, which was not sufficiently robust to reliably store all relevant data.
“Using a single CDS has significantly simplified data backup”, states Alliston. With the installation of a unified platform, data are now completely electronic, can be accessed instantly, and can be safely archived when required. “We now see the electronic data as the raw data and have confidence that it is secure for its life cycle”.
Sterling performs thousands of injections every month, which requires assurance that workflows are operating efficiently. The nature of the previous CDS meant that a significant amount of time was lost to the manual setup of repeating sequences. In contrast, analysts using the integrated CDS are immediately able to gather high-quality data, by automatically performing user-defined tasks such as sample re-injections or dilutions.
Data processing was a major part of allocated time in the previous workflows, but through the use of advanced computer algorithms, the company now operates more efficiently. “Before we upgraded our CDS, we relied heavily on user-defined peak identification and integration. These days, user-defined integration is the exception, rather than the norm,” says Alliston.
Figure 1 shows how powerful this technique can be, with an example of an integration algorithm defining 20 peaks in the first attempt.
Alliston explains that the company now uses a custom query to calculate the extent of the manual integrations performed each month. Figure 2 shows the decrease of manual integration that has occurred within Sterling since adopting the CDS solution. “Within our formulated products team, we’ve had 100% automated integration for the last six months. All of our groups are steadily reducing manual input too,” Alliston adds.
With the previous CDS set-up, analysts would perform calculations in custom-built spreadsheets. However, manually transcribing data generated in this way increased the chance of human error, and subsequent checking of the spreadsheet for these errors was time-consuming, adding to the overall workload of the analyst.
The innovative CDS that Sterling installed allows for customizable report templates within the software itself. These spreadsheet-based reports can be tailored to provide the specific data that is required for each method, product, or project. By performing all calculations within the software, results are consolidated, and the need for additional packages eliminated. This has led to more robust data and a significant reduction in human error.
Implementation of an integrated CDS across the entire organization has enabled Sterling to analyze the performances of all chromatographic workflows. By monitoring this data, reliable information about the efficiency of workflows can be gathered, assessed, and amended as needed. This allows for the oversight of all operational performances, and information can be traced from a particular method, instrument, or analyst. “It’s a really powerful tool”, says Alliston, “we’re able to predict how performance will trend in the future, allowing us to take action in good time”.
The analytical instruments can also be monitored and routine maintenance conducted on them in a timely manner. By analyzing trends in the data generated from these instruments, the analyst can see when performance is sub-optimal. If, for example, an increase in failed runs is seen, the instrument can be repaired before the issue becomes serious. This also allows Sterling to schedule all maintenance at a convenient time, reducing critical downtime and project delays.
The new integrated platform has allowed the company to move away from old inefficient workflow practices, and by monitoring and trending the data produced, the company is able to further optimize processes. The new platform has also reduced paper trails with the move to a company-wide electronic system, which boosts efficiency and productivity. “We recently trialed a data review process based on electronic signatures within our Formulated Products team, which proved very effective at streamlining workflows, and we’ve decided to implement this within the team on a permanent basis,” according to Alliston.
“We are audited on an increasingly regular basis. Compliance to regulations shows we are in control of our processes and gives our customers confidence in our abilities to meet their needs. With our new CDS, this is easily possible,” he adds.
Peter Zipfell is product marketing specialist, CMD Software, Thermo Fisher Scientific.