The increasing complexity of pharmaceutical products, such as chimeric antigen receptor T cell (CAR-T) and gene therapies, means that today’s pharma manufacturing workflows create more data than ever before. From resource planning and chain of custody data through to environmental monitoring and quality control checks, modern drug production processes generate a wealth of multi-dimensional information that is ultimately used to ensure the efficient delivery of safe, high-quality products.
As the volume of information associated with pharmaceutical manufacturing workflows has grown, so too has the emphasis by regulatory bodies on the accuracy and completeness of this data. With public safety and consumer trust on the line, regulators now expect even higher standards of data integrity — requiring open and transparent record-keeping to support full traceability and accountability throughout the manufacturing chain, as well as the secure collection, storage and archiving of data to prevent inadvertent errors or the deliberate manipulation of data.
Given the additional pressures facing pharmaceutical manufacturers around information management, the systems and tools companies use to control their workflows must be capable of handling large volumes of data, as well as ensuring that searching and recalling this data is quick and easy in the event of an inspection or audit. Naturally, to support ongoing business growth and meet evolving market needs, these approaches to data management also need to be scalable and flexible. Despite this, many companies still use paper-based records and off-line spreadsheets to manage their data, which present a number of serious challenges.
The quality control data challenge
A fundamental flaw with paper and spreadsheet-based approaches to information management is that they require data to be inputted or updated manually, leaving records vulnerable to human error. To minimize issues during data entry or transcription, many pharmaceutical companies implement additional verification and review processes. However, these steps inevitably extend the time taken to process information and can delay decision-making, causing costly hold-ups to the production line.
Moreover, given the manual way in which data is recorded, it can be challenging or even impossible to reliably determine when information was collected and by whom. With stacks of paper records or off-line spreadsheets to locate and review, these outmoded approaches make searching and retrieving data in the event of an audit time-consuming and resource intensive. Furthermore, as businesses expand their operations and the volume of data grows, these challenges often become increasingly difficult to manage.
Given the issues associated with controlling and sharing information using paper and spreadsheet-based workflows, pharmaceutical manufacturers are finding they need more robust tools to meet modern regulatory expectations around data integrity. To do this in a way that maintains commercial competitiveness and facilitates future business growth, these solutions must provide high levels of scalability and flexibility. So, what’s the solution?
For many businesses operating in the pharmaceutical sector, extensible cloud-based laboratory information management systems (LIMS) are proving to be a powerful solution. LIMS platforms provide a centralized approach to data management, enabling manufacturers to bring together all of their production processes, raw material checks, environmental monitoring, and quality control workflows into a single integrated system. By connecting users with their workflows and instruments, and consolidating data management, the latest LIMS solutions provide a fast and convenient way to access the data necessary for batch release in a fully validated system—boosting operational efficiency, improving data quality and safeguarding regulatory compliance.
One way in which LIMS are achieving this transformation is by standardizing quality control testing workflows. Using a LIMS to store and maintain standard operating procedures (SOPs), templates and worklists, users can download information, such as method protocols and parameters direct to instruments. By simplifying the execution of SOPs and ensuring critical quality control tests are conducted in a standardized way, regardless of where they are performed and by whom, LIMS significantly reduces the potential for human error and enhances the integrity of data.
Another benefit of operating a LIMS is that, once collected, all results and instrument metadata are automatically stored, managed and securely archived within the system. Having all the information in one place enables authorized users to access key insights from any location, at any time, to accelerate batch release. The intelligent algorithms included in more advanced LIMS software can automatically perform analysis tasks (such as peak integration or data trending) to reveal key insights much faster. Together, these tools can, for example, allow manufacturers to quickly compare product batches with standards or automatically generate certificates of analysis in a much shorter timeframe than with fully manual review workflows.
With the latest requirements around data integrity putting a particular emphasis on robust record-keeping, maintaining a detailed audit trail of all actions and decisions taken from data collection through report generation to final batch release is essential. With all user interactions with the system stored centrally within a LIMS, recalling audit trails is considerably faster and more convenient than with paper records or disparate spreadsheets. The powerful search tools provided by some of the latest LIMS software enable authorized individuals, such as laboratory managers, to more quickly identify unusual or non-compliant behavior. With all relevant details available at the click of a button, action can be taken much faster and the risk to noncompliance is greatly reduced.
Flexible, fully-validated cloud-based LIMS
Developing and validating large-scale IT projects in-house can often be disruptive, resource-intensive and time-consuming. However, the considerable flexibility offered by cloud-based architecture means making the transition to a fully integrated digital ecosystem is often quicker and more straightforward than is commonly expected.
Many of the latest LIMS platforms can be implemented ‘off-the-shelf’ and can be easily configured to meet the requirements of individual manufacturers without the need for extensive customization. Some systems can even seamlessly integrate data from electronic laboratory notebook platforms, for example, helping businesses scale their operations quickly, with minimal disruption to output. Moreover, once implemented, these highly adaptable platforms allow pharmaceutical companies to accommodate changes in workflows, such as additional lots, products and protocols, without the need to reengineer or revalidate the whole system.
This high level of versatility also extends to the way in which these systems are managed. Some of the more flexible LIMS can be installed on both traditional in-house IT infrastructure as well as private cloud networks, providing businesses with effective implementations tailored to their own specific requirements. In this way, cloud-based solutions can be a scalable and cost-effective solution for even small businesses, enabling them to benefit from fully-validated IT infrastructure and LIMS without having to invest the time and resources into building, maintaining or upgrading these systems in-house.
Some cloud software providers also offer extensive libraries of preconfigured applications and tools that businesses can download and install as their requirements evolve. These modular applications, which have been previously validated and are fully compliant with the latest regulatory standards, enable organizations to quickly integrate new features with their LIMS and use them straight out of the box. Thanks to this flexible and scalable approach, these powerful cloud-based informatics solutions are helping companies expand and adapt their capabilities more cost-effectively.
As the data collected during the production of modern therapeutic products grows in both volume and complexity, many pharmaceutical manufacturers are finding that traditional approaches to data management are inconvenient and ineffective. Moreover, as regulators focus more intensely on the quality and integrity of this information, more robust solutions are required. Cloud-based LIMS provide pharmaceutical manufacturers with a scalable and flexible solution to managing pharmaceutical production line data, empowering growing numbers of manufacturers to improve productivity and efficiency while achieving full regulatory compliance.