“Unlocking Compliance Success: A Comprehensive Review of FDA and CSA Guidelines”This whitepaper gives a clear information on regulatory frameworks established by the U.S. Food and Drug Administration (FDA) and the…Mar 24Mar 24
FDA Inspection ReadinessFDA Inspection Readiness is a critical process for businesses in industries regulated by the U.S. Food and Drug Administration (FDA), such…Mar 24Mar 24
Process Analytical Technology | PAT Pharma 4.0Process Analytical Technology (PAT) in Pharma refers to a system for designing, analyzing, and controlling pharmaceutical manufacturing…Mar 10Mar 10
Quality Assurance vs. Quality Control in Life SciencesIn the highly regulated world of Life Sciences and Biotechnology, the terms Quality Assurance (QA) vs Quality Control (QC) takes critical…Feb 24Feb 24
21 CFR Part 11 Compliance for Medical Device ManufacturesWhen it comes to 21 CFR Part 11 compliance for medical device manufacturers, the FDA emphasizes the criticality of robust documentation…Jul 9, 2024Jul 9, 2024
US FDA Process Validation GuidanceThe U.S. FDA (Food and Drug Administration) provides guidance on process validation for the pharmaceutical industry. Process validation is…Feb 29, 2024Feb 29, 2024
Software Quality Assurance(SQA) BenefitsSoftware Quality Assurance (SQA) offers numerous benefits to software development projects, teams, and organizations. Here are some of…Feb 20, 2024Feb 20, 2024
An overview of FDA 21 CFR Part 11 complianceFDA 21 CFR Part 11 sets forth regulations regarding electronic records and electronic signatures in industries regulated by the FDA…Feb 19, 2024Feb 19, 2024
key Stages In The Data Integrity LifecycleData integrity lifecycle refers to the complete process of managing data within an organization or system while ensuring its accuracy…Feb 16, 2024Feb 16, 2024
