Advanced laboratory software can open a path to high-quality, compliant chemical manufacturing
Chemical manufacturing is critical for the economy and society, providing the key building blocks for the manufactured goods that make modern living possible. But chemical manufacturers face serious challenges — from tightening regulations to mounting pressure to do more with less. Advanced informatics tools, however, are showing promise to help alleviate such concerns.
This article outlines the key difficulties confronting chemical manufacturers today, as well as provide guidance on how advanced laboratory information management systems (LIMS) can help overcome these issues by enabling more efficient quality control (QC) operations that produce better quality products, faster, while easing the path to compliance.
Reacting to tough industry challenges
Today’s chemical manufacturing landscape is fraught with challenges. And those challenges show no sign of easing. The most pressing include:
- Stringent, tightening regulations. Data integrity requirements continue to grow, adding to the complexity of chemical production and QC workflows.
- Business profitability pressures. A need to do more with less means manufacturers must continually find ways to increase throughput and productivity.
- A sharp focus on quality. At the same time, manufacturers must deliver high-quality products, consistently, if they are to meet customer expectations and stay competitive.
FIGURE 1. Tightening regulations surrounding data integrity are among the challenges facing manufacturers
Overcoming these challenges demands repeatable, efficient and standardized chemical production and QC processes with minimal errors. Yet, many manufacturing QC laboratories still rely on error-prone manual processes and use legacy software with disconnected systems and processes. Consequently, addressing these challenges has become more difficult than necessary.
Advanced laboratory software can be a catalyst for QC success
The next generation of LIMS offer a solution. While many laboratories already have a LIMS or some form of software to help manage their production and QC, they are potentially missing out on the expanded capabilities offered by the most advanced LIMS.
So, what specifically are the benefits of advanced LIMS software?
Delivering a connected lab: reducing errors and promoting data integrity
First, advanced LIMS deeply and comprehensively connect data, people, processes and instrumentation in the lab. With a more connected laboratory, manufacturers can benefit from automatic data and metadata transfer between their LIMS and instruments, eliminating manual transcription and reducing errors. Moreover, some advanced LIMS can connect to portable/mobile devices, enabling remote access to the LIMS. As such, analysts can check their processes and record data in real-time, without needing to rely on memory, helping further reduce errors and avoid information gaps.
Furthermore, advanced LIMS help drive data integrity by capturing and meticulously tracking all data and metadata from connected instruments, devices and people, providing a full audit trail detailing the “who, what, when and why” of their data, which analysts or regulators can then easily review.
Another way LIMS drive data integrity is with secure storage of lab data — both onsite or in the cloud — with passwords and eSignatures that comply with the regulatory requirements set forth in FDA 21 CFR Part 11.
Faster, more cost-efficient, scalable operations
As well as supporting data integrity and reduced errors in the lab, advanced LIMS also help labs to accelerate operations and make them more cost-efficient and scalable — which is critical given industry pressures to grow throughput and profitability.
For example, with the automated workflow capabilities of some advanced LIMS, laboratories can quickly configure workflows that are mapped to their unique processes, automating decisions and actions to reduce user intervention. This enables teams to optimize use of analyst time, tools, and other laboratory resources for accelerated and more cost-effective operations. Moreover, with automated, easily configurable workflows, laboratories can more easily adapt to new methods and process changes. The benefits of workflow capabilities don’t stop at a single lab or site, either, since workflows can be easily shared across sites and regions to drive more standardized processes. Laboratories that follow standardized processes reap greater efficiencies, since training and onboarding of new staff is easier, results are more comparable and learnings and improvements at one site can be quickly applied to others.
Cloud deployments can add further speed, cost savings and scalability advantages. With a cloud-based LIMS, chemical manufacturing QC labs don’t need to invest in, deploy, and maintain costly on-site IT infrastructure. Cloud deployment means they can also more easily, swiftly and cost-effectively scale their operations, since they won’t be hindered by the physical IT infrastructure in their lab.
Properly working and well-maintained instrumentation is vital for any laboratory looking to boost efficiency and productivity — it only takes one unexpected instrument failure to halt operations and drastically reduce output. The most advanced LIMS, however, are well-equipped to reduce the likelihood of such a scenario. Some LIMS feature a complete calibration and maintenance system, which can help labs ensure all their instrumentation and equipment is working correctly and checked at regular intervals, as well as enabling them to plan, schedule and prepare for any instrument and equipment maintenance. Labs can therefore maximize instrument and equipment uptime and productivity.
What’s more, the most advanced LIMS now offer powerful trending and analytics capabilities, which help analysts extract richer insights from their data and metadata. With these tools, laboratories can now predict testing results using historical data, helping save analyst time and lab resources, and driving faster, more informed decisions. Forecasting capabilities also help labs better plan for what’s coming, enabling them to anticipate and mitigate resource bottlenecks to minimize the chance of disruption and delay. Advanced analytics and trending can also help analysts better predict outages and equipment issues, meaning labs can better plan for, and mitigate the impact of, any operational downtime. Ultimately, with a clearer insight into the current and future state of their processes and operations, labs can better find ways to optimize their operations for improved productivity.
Enhanced product quality, better process control, faster product release
The benefits of LIMS don’t stop at compliance, speed, cost-effectiveness and scalability. The latest LIMS help labs control their processes and better maintain the quality of their products, too. By enabling labs to scale while ensuring quality, organizations will be able to better serve their customers and maintain their reputation.
One way they do this is through greater process visibility. Take for example, the fact that modern LIMS can now offer complete traceability from the receipt of raw materials right through to product release. Labs can use this information to continually track and measure quality output in real-time against specifications at each manufacturing step, as well as get alerts for non-compliance and rejection or acceptance. Manufacturers can, therefore, more easily identify and rectify issues in their production processes as they happen to ensure consistently high-quality products. The ability to review the data retrospectively is also of great benefit — collected data can be reviewed at any time, so labs can easily complete audits as required, whether for internal purposes or regulators.
Enhanced non-conformance management is another important feature of modern LIMS. In the most advanced LIMS, templates for different non-conformance types drive analysis, corrective action decision, and approval. Corrective and preventative action (CAPA) workflows can be uniquely defined based on the type of incident, too. The result? Manufacturers can ensure the most appropriate response to non-conformances and more effectively enable continual improvement of their manufacturing processes.
Additionally, LIMS can enforce adherence to laboratory methods, giving labs greater control over their process and how they are executed. This is often through features that guide analysts through standard operating procedures — for example, by providing detailed step-by-step instructions for each method, complete with illustrations and videos to demonstrate the correct analytical technique. In-process checks also confirm user qualifications, and analysts get immediate verification of correct step execution, adding additional assurance that they are adhering to predefined processes.
Checking that products are of a suitable quality for different customers and uses is critical in chemical manufacturing, but it can be cumbersome and potentially error-prone when done manually. Importantly, delivering a product of the wrong specification and quality can have significant consequences, both for customers and chemical manufacturers’ relationship with them. Modern LIMS help overcome this issue, though, by automatically checking products against various specifications, confirming their suitability for different customers, markets, seasons and more. That way, manufacturers can more easily ensure that their products meet the quality requirements of their intended purpose, and so continue to deliver for their customers.
Some advanced LIMS come with built-in QC capabilities that ensure processes stay consistent and deliver accurate and reliable results, too. For example, statistical quality control packages in the most advanced LIMS enable analysts to monitor their processes over time so they can see if it is working as expected, enabling them to quickly identify and swiftly resolve any potential issues. Similarly, analytical quality control packages arm teams with the tools to check that analyses are behaving as expected, again helping them to quickly identify and correct issues to better ensure well-controlled optimal processes.
Advanced LIMS: opening a path to high-quality, compliant chemical manufacturing
Additionally to the above capabilities, LIMS can also help create accurate certificates of analysis (CoAs) more quickly. Creating CoAs is often time-consuming, but the latest LIMS can produce CoAs automatically, collating relevant results as per customer specifications, before swiftly delivering them to the relevant stakeholders. Accordingly, teams can greatly expedite the release of their products, driving greater customer satisfaction.
With these advanced LIMS tools, manufacturers can optimize their production and QC processes for greater productivity, accuracy, and scalability, all while maintaining quality and compliance.
Chemical manufacturing plays a critical role in our lives, contributing to and sustaining almost every other industry sector in the modern economy. But several challenges are making it harder for chemical manufacturers to advance their operations to the next level — from expanding data integrity requirements to the need for greater productivity without compromising product quality.
Edited by Mary Page Bailey
Author
Adam Collins is senior product specialist for digital science solutions at Thermo Fisher Scientific ([email protected]). He specializes in providing software demonstrations and technical support for organizations across multiple industry sectors who are assessing Thermo Fisher Scientific’s LIMS solutions for their laboratory needs. For over five years, Adam has worked with businesses to understand their laboratory workflows and devise software solutions to solve their challenges.