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Building LIMS for the FDA Quality Metrics Reporting Program

Increasingly, businesses in the life sciences industry are realizing the lasting effects that data management, integrity, and reporting can have on a wide range of aspects of their business. Each year, data integrity deficiencies have been cited with more frequency in regulatory inspections – but now, the FDA is looking to incentivize proper data management in a new way. With the passing of the FDA Safety and Innovation Act (FDASIA), there will be a new push for continuous data management and monitoring in the form of the FDA quality metrics program.

According to the FDA, the underlying goals in asking for quality metrics are to:

  • improve the efficiency of inspections,
  • better predict and prevent drug shortages, and
  • promote responsible corporate culture.

All organizations involved in the production of drug products are requested to submit quality data reports. This includes all U.S. organizations involved in the manufacturing, preparation, propagation, compounding or processing of covered drug products. For now, submission is voluntary but eventually, all drug manufacturers will be required to submit.

Because large data reports will need to be created and submitted to meet the regulatory guidance, businesses in the life sciences industry should begin by implementing a laboratory information management system (LIMS) to ease the process of data curation and allow for greater quality management, leading to a more efficient production with greater product quality and safety.

If your organization does not have LIMS software in place, getting prepared for a quality system will ease the transition. Companies need to fully understand the metrics asked for by the FDA, but they should also be aware of any organizational quality metrics they would like to track for themselves. These can be anything from equipment downtime to environmental monitoring.

If your business would like to leverage a LIMS platform to submit quality metrics data to the FDA, there are four steps your organizations should take to prepare, implement, and transition.

First, decide how to report your metrics – either by site or product. The FDA prefers product metrics, but doing this calls for heavy harmonization between labs that work on the same product. A LIMS platform allows for data continuity across labs or sites and will be useful when reporting quality metrics.

Second, perform a data integrity assessment and shore up any identified weaknesses in your processes. Managing the flow of information from different labs/sites can help prevent potential data integrity issues. Installing a LIMS system helps keep human errors—one of the leading causes of poor drug quality—at a minimum.

Third, transitioning to a LIMS system is a long-term decision, requiring new tools, resources, and strategies. However, there may need to be initial solutions that are geared toward short-term goals, such as laboratory scheduling system or electronic lab notebooks. If organizations invest early in these systems, they may need to revise to incorporate into long-term operations.

Fourth, doing a thorough review of all associated master data and master data management processes is essential to the successful implementation of a LIMS or any quality management system.

Quality metrics improve efficiency and keep the drug products safe and uniform, while also improving production efficiency as they can help prevent shortages and surpluses. Failure to comply with these quality metrics, or even submit them, may lead to further investigations and audits. Standardized metrics allow for high-performing organizations to be rewarded with fewer inspections and disruptions. With quality metrics and a LIMS system, operations can become more proactive and less reactive, leading to greater efficiency, and more importantly, safeguard quality for patients.

Co-author and contributions by Emily Brice, Avery Edwards, and Irene Birbeck

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Tags: Quality and Compliance Technology, LIMS