In 2012 Sterling Pharma Solutions, a leading provider of small molecule API development and contract manufacturing services to the global pharmaceutical industry, took the decision to replace its existing chromatography data systems (CDS).
Previously, two different CDS platforms were in operation, one for each of Sterling’s laboratories, each with its own shortcomings in terms of compliance and efficiency. Having multiple systems also led to a lack of cohesion between the laboratories. The new CDS would have to be able to unite the laboratories and provide improved compliance, data integrity and efficiency across the whole business.
The company assessed CDS software from several suppliers during a rigorous evaluation project looking at ease of use, compliance, scalability, cost, efficiency gains for the business and compatibility with existing instrumentation.
Sterling decided to deploy Thermo Scientific™ Chromeleon™ 7 CDS software as a multi-laboratory solution, supporting a total of 58 instruments. These included 25 gas chromatography systems (GCs) and 33 high performance liquid chromatography systems (HPLCs) across both its quality control (QC) and R&D laboratories. Chromeleon CDS was selected for several reasons including its capacity for centralised data storage, allowing separate parts of the company to gain remote access, while ensuring data security. The high level of cGMP compliance and data integrity offered by the software with the ability to create bespoke report templates were also critical factors in Sterling’s decision.
Due to the flexibility of the Chromeleon software it was possible to optimise the system in order to meet the goals set out at the start of the project. This would ensure continuous improvement and compliance with the latest regulatory requirements. These goals were:
- To find a new CDS system that could adequately cater for the high-throughput of samples in Sterling’s analytical department.
- Find a system that was easy to use as well as being scalable,
- Implement one system that integrated the company’s entire operation and existing instrumentation, ensuring a cohesive and multi-laboratory solution.
- Employ a system that had the potential to help the business realise cost and efficiency improvements.
- Improve compliance and data integrity across the whole business.
Compliance and data integrity
The need for improved data integrity and compliance to meet modern regulatory standards was one of the key drivers behind the move to a single CDS.
As with all QC laboratories, Sterling is audited by customers on a regular basis. Compliance with regulations shows that the business is in control of its processes and gives its customers confidence in its abilities to meet their respective needs.
The two former CDS platforms were unable to meet modern compliance and data integrity standards and neither system could meet the security requirements for electronic data that would allow the organisation to transition away from paper-based systems.
Chromeleon CDS has improved Sterling’s data integrity and supports compliance with 21 CFR Part 11 and the Medicines and Healthcare Regulatory products Agency (MHRA) GMP data integrity definitions and guidance for industry. The improved level of data security means that the electronic data can now be submitted as the raw data, replacing the paper records that were originally required. Both the company and its customers can be confident that data is being transcribed correctly and maintained securely throughout its entire life cycle.
The audit trails in Chromeleon CDS are very comprehensive and will track everything that the user and system does. Users now regularly review the audit trails for each sequence. With the audit trails easily accessible on-screen and the ability to group, filter and search for events, it is very quick and easy for users to review and allows them to ensure that the correct versions of files, such as instrument methods and report templates, are used for each analysis. In addition, it is also possible to revert to previous versions and easily track where changes have been made.
In the last two years, audits from the US Food and Drug Administration (FDA), Russia’s Federal State Institution and EU MHRA and numerous external customers, have been passed with no major citations.
Increasing laboratory efficiency
The business’ need for increased laboratory efficiency was also a major factor in the decision to move to a single CDS.
Data processing has long been one of the most time-consuming tasks in every laboratory and this was no exception at Sterling. Use of smart data processing tools such as the Chromeleon CDS CobraWizard™ and SmartPeaks™ Integration Assistant has helped improve laboratory efficiency.
Use of the Cobra Wizard allows for quick setup of optimum integration parameters and ensures consistency across all of Sterling’s laboratories. Performance improvements were notable when comparisons were made with the former CDS platforms. One area of concern at Sterling was the over-reliance on manual integration by its system users. The new software has readdressed this balance with manual integration becoming the exception and not the norm.
Previously, with data being stored on two separate systems, and with only a limited number of analysts able to use both, data retrieval could be difficult and very time consuming. The ability to monitor laboratory-wide key performance indicators, such as instrument utilisation, was severely hampered.
Data retrieval and processing are much simpler with Chromeleon CDS and the use of a folder/file naming principle makes it possible to locate data quickly and easily. A single, centralised system also allows the laboratories to easily share instruments and data, making method transfer much easier.
Sterling is now looking to use available method validation report templates, modified to its needs, to increase the throughput of method validation activities and provide a clear and consistent report to its customers.
Data management improvements
With the previous CDS platforms, although it was possible to carry out calculations within the CDS, it was very common to see data being transcribed into spreadsheets to perform calculations. This led to significant inefficiencies as all the transcriptions took time and they also needed to be checked, duplicating the effort.
Chromeleon CDS removes the need for manual input of data into spreadsheets to perform calculations. With its built-in spreadsheet reporting engine, it offers increased flexibility for reporting along with instant familiarity for spreadsheet users. Chromeleon software allows product-specific templates to be set up, reporting the exact data needed for each product and removing the need for transcribing and checking data.
This has moved Sterling away from the inefficient practices of transcribing data into a spreadsheet and helps the business to address data integrity within the laboratory. The company is now moving toward a fully electronic system with the intention to use electronic signatures for data review and the implementation of eWorkflow™ procedures.
Sterling is looking to fully implement and use electronic signatures to minimise paper usage. The company will be transitioning through a hybrid system (both paper and electronic signatures) and trialling the new approach on an individual process to evaluate best practices.
Sterling is also looking to implement eWorkflow procedures to further improve efficiency and data integrity in the laboratories. These ensure that the correct methods and reports are always being used and analyses are performed in accordance with its Standard Operating Procedures (SOPs). This will save the businesses significant time when reviewing data, as well as allow Sterling to continuously improve its service and maintain customer confidence.
Brian Alliston is currently a Data Integrity Expert and CDS Specialist at Sterling Pharma Solutions Ltd. As the head of the Chromeleon Administration Team and the department’s Data Integrity Specialist, Brian supports a multifunctional group of QC and development analysts in the use of the Chromeleon Chromatography Data System (CDS). He also oversees the development of training procedures, SOPs, and product-specific report templates. Brian has a degree in applied chemistry from the University of Northumbria, Newcastle and has over 18 years’ experience in the pharmaceutical industry working in both QC and development environments.