When you take your medicine, you assume it is safe and fit for purpose, automatically trusting the manufacturer to make good decisions based on reliable information. The onus is on them to ensure that the analytical data that underpins decision-making at every stage of the product’s lifecycle are demonstrably valid and accurate.
Data integrity is fundamental in enabling the pharmaceutical industry to deliver on its responsibility to ensure the safety, efficacy, and quality of its products. While the concept of data integrity is not new, for some time it has been the subject of intense regulatory focus and there are many reports of data integrity-related CGMP violations.1 These raise concerns about product and patient safety and, for the companies involved, can have serious commercial consequences.
Manufacturers and analytical laboratories are required to operate systems that demonstrate acceptable control, and they must be able to prove to the regulators that analytical results are neither erroneous nor fraudulent. In pharmaceutical laboratories, two of the most widely used analytical techniques are chromatography and mass spectrometry. These generate huge amounts of data, which inform critical decisions from pharmaceutical development through to manufacturing and quality control.
Here we examine some of the challenges in securing the integrity of that data, drawing on first-hand experience at Sterling Pharma Solutions of implementing an advanced chromatography data system (CDS) to improve laboratory compliance, data integrity and efficiency.
The challenges of data integrity
Data integrity and its requirements apply to both paper and electronic records. Increasingly, however, laboratories are adopting electronic data management solutions. Not only do these offer greater security and improved efficiency they can bring together previously disparate systems. A modern CDS that complies with both US Food and Drug Administration (FDA) and Medicines and Healthcare Products Regulatory Agency (MHRA) regulations must also support productivity while ensuring the compliant, efficient, and reliable handling of data.
The guiding principles of data integrity (ALCOA+ 2) state that data must be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available. These nine expectations serve to identify any weaknesses in a data lifecycle and strengthen data generation, both for electronic and any paper elements. Regulatory guidelines support validated documentation, and they outline parameters such as audit trails, electronic signatures and thorough reviews. An advanced CDS must be able to organize all the requirements needed to comply with the regulations.
A critical aspect of data integrity is documenting who did what, why and when. This provides context and makes data attributable to individual users. For electronic records, FDA 21 CFR part 11, MHRA and EU Annex 11 GMP guidelines all require computer-generated time-stamped audit trails, the ability to show all changes to data, and for reviews to be confirmed and recorded. Here, an advanced CDS helps ensure compliance through automatic audit trail functions, the provision of unique user accounts, automated time stamps and date entries, and a requirement to comment on any data modifications.
An ideal CDS solution provides essential support to a laboratory by ensuring data quality and by managing all the analytical processes, from instrument control to raw data storage and processing, right through to generating the final results.
Real-world implementation of an advanced CDS
Sterling Pharma Solutions is a long-established provider of contract development and manufacturing services to the pharmaceutical industry. Its busy analytical department has a high throughput of many different sample types, with testing ranging from simple purity checks through to complex assays, method development, transfer and validation studies. Historically, each of the department’s two laboratories operated its own CDS, a situation that needed addressing in the interests of bringing cohesion as well as improving compliance, data integrity and efficiency. Key goals were to move away from any manual transcription of records and implement a single CDS that would work across both laboratories, with existing instrumentation. There was also a business imperative to increase laboratory efficiency.
Rigorous evaluation of different CDS software included looking at ease of use, compliance, scalability and possible cost and efficiency gains. The final decision to go with the Thermo Fisher Scientific Chromeleon CDS software as a multi-laboratory solution was made for several reasons, primarily centralized data storage and the ability of both laboratories to use the same system with existing instruments. At roll-out the CDS was supporting 58 instruments — 25 GCs and 33 HPLCs — across the two labs, replacing the previous two separate systems that both lacked the security requirements needed to transition to electronic data as the primary raw data. They needed a CDS that delivers the high level of CGMP compliance and data integrity required to make that possible and today it supports 83 chromatography instruments.
The CDS both manages the requirements needed to comply with data integrity regulations and automates systems, so that laboratory processes are standardized. Previous manual transcription of data was error-prone and risky. Now the automatic transfer of electronic raw data more than meets regulatory expectations, giving confidence that it is secure and enduring for the whole of the data life cycle. What’s more, comprehensive audit trails track everything that the user and the system does so, at audit, customers can readily see that processes are in control, and users are easily able to manage QA reviews and compliance.
The benefits of a single system
Immediate benefits of Sterling Pharma Solutions’ CDS implementation were to centralize operations and data management, move away from paper records and have electronic data as their primary data source. The improved compliance and data integrity achieved are critically important to customers in assuring the security and reliability of laboratory results and processes, and ultimately the efficacy and safety of their own products.
The new CDS has resulted in gains in efficiency, largely thanks to its ease of use and high-speed data processing and retrieval. Smart data processing tools help in quickly setting up optimum integration parameters and have enabled the phasing out of manual integration. In addition, the simple clear interface and intuitiveness of the system have reduced training requirements, saving a considerable amount of laboratory time.
Having the ability to monitor lab-wide performance from a single centralized system now provides a platform for driving increased efficiency and further method improvement. The cohesiveness in procedures from a single and centralized system simplifies activities and allows easy access to data. This easier data retrieval, better sharing and complete instrument visibility makes it simple for laboratories to share instruments and transfer methods. It has brought the labs and customers closer together and made all methods more transparent, supporting further collaboration and partnership.
With the recent acquisition of sites in the US, Sterling Pharma Solutions is looking to connect multiple sites with their new CDS and manage from one centralized location. Pilot studies for a cloud solution are planned, with a view to extending the benefits of centralizing operation and management.
With data integrity a regulatory priority, pharmaceutical laboratories have increasingly moved to electronic data management systems. Today, advanced chromatography data systems play a crucial role in streamlining laboratory operations, supporting better productivity and improving compliance in a single software platform.
For Sterling Pharma Solutions, the implementation of innovative CDS across two laboratories and multiple instruments enabled a move away from manual data transcription. It improved data integrity and compliance, and at the same time provided the means to drive greater efficiencies across laboratory processes.
