The jabbed are spreaders…

2 screenshots from UK Column news 28/7 on hospitalizations in UK and Israel, NBC saying what Fauci also admitted and awake suspected- the jabbed are spreaders.. Informed consent for an experimental gene therapy injection is required by law, Code of Federal Regulations Title 21 Part 50 Protection of Human Beings. Subpart B – Informed ConsentContinue reading “The jabbed are spreaders…”

How to Avoid Electronic Data Integrity Issues: 7 Techniques for your Next Validation Project

The idea of this article was taking (with permission from the original authors) from Montrium:  how-to-avoid-electronic-data-integrity-issues-7-techniques-for-your-next-validation-project Regulatory agencies around the globe are causing life science companies to be increasingly concerned with data integrity.  This comes with no surprise given that Guidance Documents for Data Integrity have been published by the MHRA, FDA (draft), and WHO (draft).  In fact,Continue reading “How to Avoid Electronic Data Integrity Issues: 7 Techniques for your Next Validation Project”

BIMO Inspections – GCP Dilema

BIMO stands for Bioresearch Monitoring. The FDA releases each year, a list of findings for FDA-regulated product that may be in violation of the agency’s requirements. These inspections’ findings are listed on an FDA Form 483 by the inspector. Last year, there were over 600 findings from different FDA’s BIMO program (i.e., clinical investigators, IRBs,Continue reading “BIMO Inspections – GCP Dilema”

Good Documentation Practice (GDP) for the EDC / SAS Developer

When writing programming codes for either validating the software or for validation checks, we often have to write comments to explain why we did something. Since the FDA regulates computerized systems used in clinical trials under the authority of Title 21 the Code of Federal Regulations Part 11 (21 CFR Part 11) – see myContinue reading “Good Documentation Practice (GDP) for the EDC / SAS Developer”