Trends in FDA Data Integrity 483s and Warning Letters for Pharmaceutical Companies
The manufacture of pharmaceutical drugs is a highly complex process that involves advanced scientific analysis and instrumentation at all stages of production and storage. In order to guarantee the safety and efficacy of both human and veterinary drugs, the FDA strives to verify data integrity in all cGMP records used to document and guide the […]
Considerations for Cloud Hosting Your Laboratory Informatics Systems
Traditional on-premise Laboratory Informatics Systems in scientific laboratories are often accompanied by significant operational costs – securing the data, applying patches, providing backup and disaster recovery, hardware maintenance, etc. Public, multi-tenant cloud-based systems accessed “as a service” share infrastructure across several customers and deliver value by managing those systems with shared resources and procedures that […]
Integrating Multiple LIMS into a Single System
In today’s global economy, mergers and acquisitions have become a dominant strategy to improve profitability, maintain competitive edge, and expand services and reach. This practice is common in several industries such as pharmaceutical, biotech, food and beverage, oil and gas, and others. While corporate mergers certainly can provide several benefits for the organizations involved, they […]
Benefits and Best Practices for Integrating Laboratory Instruments with LIMS
Due to technological advances in laboratory instruments and higher throughput processes, data volumes in modern analytical laboratories have increased dramatically over the last several decades. While this increased data volume presents the opportunity to improve innovation and enable timely and effective business decisions, it also presents significant data management and processing challenges. In order to […]
Enhancing Data Integrity in Clinical Research with Blockchain Technology
Verification of data integrity is a critical part of the FDA’s mission to ensure the safety, efficacy and quality of human and veterinary drugs, biological products, and medical devices. As these products must undergo extensive testing before being approved for the public, gathering high-quality, reliable and statistically sound data is an important goal for all […]
Accelerating Drug Discovery and Development with Artificial Intelligence
With the rate of data generation increasing exponentially in today’s technology-driven R&D world, there are both enormous opportunities and real challenges for science-driven organizations in transforming this data into pragmatically useful insights. For example, in the biopharmaceutical industry, Next Generation Sequencing screening technologies generate terabytes of data in a single run and automated bioreactors create […]
Creating an Effective Validation Master Plan
The Food and Drug Administration (FDA) is tasked with protecting the public health by ensuring the safety, efficacy, and security of the nation’s food supply, human and veterinary drugs, biological products, medical devices, vaccines, and other products. In order to fulfill its mission, the FDA requires that all products under its domain meet guidelines outlined […]
Data Integrity: The Importance of a Quality Culture
Verification of data integrity is a critical part of the FDA’s mission to ensure the safety, efficacy and quality of human and veterinary drugs, biological products, and medical devices. As such, the FDA’s expectation is that all data generated to support the quality of manufactured products is both reliable and accurate. Compliance violations involving data […]
What the FDA’s New Guidance on Data Integrity Means for Pharmaceutical Companies
Data integrity is an important consideration in today’s pharmaceutical GxP laboratories. Compliance violations involving data integrity have led to numerous regulatory actions by the FDA in recent years, including warning letters, import alerts, and consent decrees. As part of its mission to ensure the safety, efficacy and quality of products produced by the pharmaceutical industry, […]
LIMS Selection for Genomics Labs
Next generation sequencing (NGS) is a parallel DNA sequencing technology that is able to carry out hundreds to millions of DNA sequencing reactions in parallel, along with the analysis of the sequencing data that is being produced. Utilizing this high-throughput NGS technology, researchers can now sequence an entire human genome quickly and relatively inexpensively, allowing […]
Utilizing Laboratory Information Management Systems (LIMS) for Lab Automation
In many scientific laboratories, routine laboratory operations are still carried out using manual, paper-based systems. Paper-based systems can be everything from transcribing instrument test results to managing inventories and documenting and scheduling instrument calibrations on spreadsheets. Lab automation is a critical business re-engineering that is enabled and optimized with the implementation of a good LIMS […]
Best Practices for Computer System Validation
Computer system validation (CSV) is a documented process that is required by regulatory agencies around the world to verify that a computerized system does exactly what it is designed to do in a consistent and reproducible manner. These regulatory agencies require CSV processes to confirm the accuracy and integrity of data in computerized systems in […]