Clarkston’s team of life sciences consultants have highlighted the top quality and compliance trends that businesses should consider. See an excerpt of the trends report below, and read all 5 trends for 2025 by downloading the full report here.

2025 Quality and Compliance Trends

As life sciences companies develop new therapies and technologies, patient safety remains a top priority. Pharmaceutical manufacturers are continuously enhancing their quality systems to align with evolving regulatory standards, ensuring the safety and effectiveness of their products. In 2024, we saw a rise in a quality-driven culture that emphasized the use of mature Quality Management Systems. Now, companies are turning to innovative technological approaches to further strengthen these quality systems. As these therapies become more complex, the FDA continues to release new guidance to uphold patient safety. Below, we dive deeper into five key quality and compliance trends for 2025: 

Trend #1: Streamlining Laboratory and Quality Management Systems 

Life science companies utilize both Quality Management Systems (QMS) and Laboratory Information Management Systems (LIMS) to maintain safe and reliable product manufacturing. These systems are integrated to allow the flow of information between the two. For example, test data from a rejected batch can be transferred from the LIMS to populate a deviation record in the QMS. Veeva, a leading Quality Management System, has created the Veeva Vault LIMS, a novel software that unifies LIMS and QMS. More than 175 companies use the Veeva Vault Quality Management system, all of which can benefit from the novel integration of systems.  

This integrated system will allow for more streamlined functionalities. For example, test results out of specification in LIMS can be communicated to QMS, which will trigger an investigation of the batch. The system integration reduces cycle time, or the turnaround time from batch execution, data review, and analysis, leading to batch release or investigation. This reduced time will increase manufacturing productivity, leading to faster production and potentially even faster research and development. The system has completed the initial pilot program and has entered Phase 2 implementation, in which the LIMS Vault is available to a limited number of users. 

Trend #2: Rise of Real-Time Release Testing 

Pharmaceutical and biotechnology companies are constantly enhancing their manufacturing capabilities to improve product reliability. One emerging quality management approaches includes Real-Time Release Testing (RTRT): a quality control method that can reduce the time to batch release by expanding the testing regimen during the manufacturing process. By collecting samples at various production stages, companies can closely monitor intermediate products for inconsistencies or errors. This proactive approach enables faster adjustments to the manufacturing line, reducing product waste and improving overall efficiency. 

Process Analytical Technology (PAT), a standard of intermediate product specifications, is one method used to achieve RTRT. The FDA addressed evolving quality assurance methods regarding PAT in 2004. Though this concept is not new, few companies have successfully realized RTRT. One challenge to achieving RTRT is that current tests require sample handling. This inhibits complete automation of in-process testing.  

One solution is to utilize in-line sample testing, which eases the burden of manual sample handling. Instead, sensors can quickly perform tests on the batch, further automating the process. The increased number of tests also increases the amount of relevant data, and companies may need to expand cloud storage and take additional precautions to ensure data traceability. 

Integration between laboratory equipment and LIMS can contribute to a more automated quality assurance system. Empower is one example of software that can provide an interface between laboratory instruments and LIMS while remaining compliant with regulatory standards. This reduces the time laboratory personnel spend manually entering and analyzing data, also reducing the risk of human error. By implementing RTRT systems, companies can decrease testing time and create a leaner manufacturing process. Continue reading by downloading the full report below.

Download the Full 2025 Quality and Compliance Trends Report Here

Read last year’s Quality and Compliance Trends Report here.

Contributions from Lilly Saiontz