Insights On Quality Assurance
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Intro To USP <1062> - What It Is And Why You Should Use It
7/20/2023
Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs, or result in no product at all.
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Why You Need A Document Management System In Life Sciences
8/25/2022
In this blog we highlight the history and purpose of a document management system and look into the future with cloud-based electronic document software.
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Nitrosamine Impurities Deadline: Are Your Products Compliant?
11/6/2023
The FDA nitrosamine contamination guidance set deadlines of Nov. 1, 2023, for risk assessment updates and Aug. 1, 2025, for full NDSRI limit compliance.
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The 4 Phases Of CAPA Maturity: A Guide To Mastering Quality Event Management
6/22/2022
This brief provides an understanding of the roles corrective actions/preventive actions (CAPAs) serve in regulatory compliance and product quality improvement, offering a blueprint to help optimized strategies.
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Using PIMS To Leverage Your MES Data For Process Lifecycle Insights
12/28/2023
Get the most out of your MES data by asking the right questions and preparing for the future of MES in the BioPharma industry.
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Assess Your Digital Pharmaceutical Manufacturing Maturity
5/18/2023
Learn how regulated product manufacturers are meeting the demand for faster development and delivery of products to patients and where your operations fit in the digital maturity manufacturing model.
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What Are The Measurable Benefits Of Modern MES Software?
11/21/2022
Even a small amount of paper on the factory floor carries hidden costs in impeded throughput, productivity, and on-time shipment. Explore the benefits of a modern MES software solution.
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Bringing A Culture Of Innovation To Cell Line Development
8/1/2023
To optimize and standardize cell line development that benefits downstream work, organizations must focus on technology and expertise in three key areas: automation, analytics, and digitalization.
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First-Pass Yield
1/22/2024
Learn how a life sciences manufacturer generated a contextualized data set that eliminated the manual effort required to curate production data and improved their process in real time.
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The 7 C’s Of A Compliant Manufacturing Change Control System
2/8/2023
Change control is integral to continuous quality improvement and customer satisfaction. Learn about the manufacturing change control process, its requirements, and the characteristics a change control system should possess.