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 9Jul 9
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 29Feb 29
Software Quality Assurance(SQA) BenefitsSoftware Quality Assurance (SQA) offers numerous benefits to software development projects, teams, and organizations. Here are some of…Feb 20Feb 20
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 19Feb 19
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 16Feb 16
ISO 13485 and 21 CFR Part 820 are both quality management system standards that are significant in…ISO 13485: ISO 13485 is an international standard for quality management systems specifically designed for medical device manufacturers and…Feb 12Feb 12
Polarion Risk Management | Compliance Group IncA case study on Polarion Risk Management Implementation by Compliance Group Inc for a leading global innovater in Medical technology which…Jan 16Jan 16
Medical Device Packaging ValidationMedical device packaging validation is a crucial process in the development and manufacturing of medical devices. Packaging validation…Dec 21, 2023Dec 21, 2023
Non Conformance ManagementNon-conformance management is a systematic process used by organizations to identify, document, investigate, and rectify instances of…Nov 7, 2023Nov 7, 2023
