Blogs about: Computer System Validation
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FDA (CBER) Draft Guidance for Industry: BECS (Blood Establishment Computer Systems) Validation in the User’s Facility
FDA (CBER) Draft Guidance for Industry: BECS (Blood Establishment Computer Systems) Validation in the User’s Facility blood via clipart Overview The following post comes from the October 2007 D… more →
Quality meets Validation
Computer System Validation (CSV) Audit Mindmap
wrote 2 months ago: As a break from writing, I finished the first electronic version of my CSV Audit Mindmap. The intent … more →
Nobody wants to be audited
wrote 10 months ago: Just hearing the word “audit” is enough to cause any executive to cringe, especially in … more →
Electronic Document Management Systems
wrote 11 months ago: Over the past few years we have seen FDA warning letters in relation to non-compliant Electronic Doc … more →
Event Summary - IVT CSV Week
wrote 1 year ago: Last month, Globiox had the pleasure of attending IVT’s 13th Annual Computer System Validation week … more →
Innovation in Validation – The time has come
— 3 comments
wrote 1 year ago: One of the buzzwords in the pharmaceutical industry today is Innovation. I heard an industry leader … more →
Computer System Validation - terms & definitions, scope, objective, etc.
wrote 2 years ago: Drug and medical device manufacturing in the modern world relies increasingly on computerized system … more →
Full day Virtual Seminar - Effective Computer System Validation and software implementation to reduce cost and time
wrote 2 years ago: In this CSV seminar learn how to reduce validation project time, efficient documentation strategies, … more →
FDA (CBER) Draft Guidance for Industry: BECS (Blood Establishment Computer Systems) Validation in the User’s Facility
— 2 comments
wrote 3 years ago: FDA (CBER) Draft Guidance for Industry: BECS (Blood Establishment Computer Systems) Validation in th … more →
Dangers of using 'deviations' during a validation
— 2 comments
wrote 4 years ago: via flickr by megapiksel Never report incidents as ‘Deviations’ during a validation This is a c … more →
Warning about Linkedin Validation Consultants
wrote 4 years ago: Validation Consultants on Linkedin via microsoft clip art I’m writing this quick post becaus … more →
Risk Assessments for Computerized Systems in the Blood Industry
— 1 comment
wrote 4 years ago: Risk Assessment for Computer System Validation in Blood Establishments via MS Clipart Overview … more →
Validation Documentation Errors (grammar/spelling): Correct them?
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wrote 4 years ago: Reader Question: Is it worth correcting errors within validation documentation if it is technically … more →
Documents recommended for Clinical Software implementation:FDA 2007
wrote 4 years ago: Documents recommended for Clinical Software implementation: FDA 2007 guidance by nacaseven via fli … more →
AABB, FDA, and 2001 Draft Guidance: Validation Plans
wrote 4 years ago: AABB’s comment on the FDA’s Docket No. 00D-1538 Draft Guidance for Industry; Electroni … more →
