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companyconnectc
Apr 24, 20223 min read
FDA recommendation on Deleting Electronic Data
Hybrid Systems (Deleting Electronic Data) In Hybrid systems the computerized system is used to generate a record which is printed and...
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companyconnectc
Apr 24, 20222 min read
FDA Observation of Excel Spreadsheets Validation
Observation 1. Your firm has not established and documented the accuracy, reliability and performance of your computer systems employed...
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companyconnectc
Apr 24, 20221 min read
FDA Observation on Validation of Computerized System
Observation Failure to maintain a written record and appropriate validation data of computer or other automated processes used to perform...
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companyconnectc
Apr 24, 20223 min read
Electronic Records – CSV FDA Warning Letters
Observation We remain concerned that your (b)(4) adverse drug experience reporting system has not been fully validated, and may have...
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Bhumika Barve
Jan 23, 20226 min read
Change Management
Hello Readers, Hope it was a great weekend. And now as the night grows darker, and the day prepares to change from Sunday to Monday,...
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Bhumika Barve
Jan 18, 20229 min read
Basics of Project Management
Hello Readers, In today's fast-paced developing professional world, every individual should be at par with the most required soft skill...
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companyconnectc
May 29, 20214 min read
Computerized System Validation
Computer System Computer hardware components assembled to perform in conjunction with a set of software programs, which are collectively...
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companyconnectc
May 29, 20213 min read
Category Of Software & Hardware As Per GAMP Guideline & their Validation
Category of software Application are categorized into following software categories as per GAMP 5 guideline 1. Category 1 –...
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companyconnectc
May 29, 20215 min read
Top online institutes to get your "Computer system Validation training & certification
Our annual ranking on Computer System Validation (CSV) training institute aims to highlight the best providers of CSV training in India...
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