New Approach to Validation

Data Integrity App

 

New Approach to Validation

01 AUTOMATION:

USFDA supports and encourages automation as it has the potential to improve productivity and efficiency, help in tracking and trending, plus a host of other benefits.

Manufacturers can gain advantages from automation throughout the entire product lifecycle. They can reduce or eliminate human errors, optimize resources, and reduce patient risk.

 USFDA’s position is that using these software products can be an excellent way to enhance product quality and patient safety, which in the end, is the overarching goal.

 

02 CHANGING THE PARADIGM:

Current industry practice as part of CSV program is documentation heavy. Documentation is done at the expense of critical thinking and testing.

CSA brings paradigm shift in this approach by encouraging critical thinking over documentation. By using CSA concepts, companies can execute more testing with less documentation based on risk associated with requirement.


03 LEVERAGE VENDOR DOCUMENTATION:

Perform vendor assessment and based on outcome leverage vendor executed testing during designing the validation strategy of the product. If the vendor demonstrates, a strong QMS then the validation strategy can be optimized to validate the delta and high-risk scenarios.


04 RISK RATING:

CSA recommends the following streamlined risk assessment process, which aims to perform risk-based testing at requirement level (refer section 7 for more details) This simplified approach includes only two variables: • Requirement’s potential impact on product quality and patient safety. • Implementation method of the Requirement.


05 UNSCRIPTED TESTING:

Unscripted testing liberates a tester from following click-by-click level test script and allows the tester to conduct free-form testing and documenting the results. Unscripted testing includes Ad-hoc and Exploratory Testing (refer section 8 for more details)


“Trust but Verify “ Ronald Reagan

 

Across the internet, there are millions of resources are available which provide information about Everything.

 

If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity.


Data Integrity App

 

Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.

 

Data Integrity App Include 

- Basic Data Integrity Concepts

- ERES & Its Requirement

- CSV & Its best practices 

- Mock Inspection and General Q&A

- Checklist for inspection

- Inspection Readiness

- Useful SOP’s

- Stay Regulatory Compliant.

 

“Stay One Step Ahead in Pharma IT Compliance” 


Data Integrity App Link:


https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity

 

Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.

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