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Validation Documentation Articles & Analysis

5 articles found

Navigating the Crucial Path of Medical Device Validation and Verification

Navigating the Crucial Path of Medical Device Validation and Verification

Validation focuses on confirming that the final product fulfills its intended use efficiently. ...

ByProtheragen-ING


How to Achieve Quality by Design (Qbd) in a New Pharmaceutical Fill Line: Cleaning and Disinfection (Series Part 3 of 6)

How to Achieve Quality by Design (Qbd) in a New Pharmaceutical Fill Line: Cleaning and Disinfection (Series Part 3 of 6)

Disinfection: Manual (open RABS) Define the right disinfectant and sporicidal agent Disinfectant rotation • Disinfection technique Vaporization Support for reviewing validation documentation from OEM Cleaning techniques employing the use of a detergent. ...

ByParticle Measuring Systems (PMS)


6 Best Practices to Help Achieve DSCSA Compliance

6 Best Practices to Help Achieve DSCSA Compliance

T3 documentation must be securely stored for six years. Storing it in a single format and centralized location saves money and time through improved accessibility and efficiency. It’s important to consider a system that will convert paper documentation into electronic files, which is especially helpful to manage drop shipments. ...

ByConsortiEX Inc.


How To Keep Your Tablet Press Clean

How To Keep Your Tablet Press Clean

It’s also important to have systems in place to validate and document the cleanliness of the equipment. 10 Key Steps For Cleaning Tablet Presses: 1. ...

ByInternational Products Corporation


Standards in Capstone Projects

Standards in Capstone Projects

Teams define projects, identify customer needs, establish target product specifications, generate concepts, construct working prototypes and validate final designs. As an instructor with industry product development experience, my goal is to prepare students for professional engineering practice. ...

ByASTM International

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