Direct & indirect system in Computer System Assurance

 

Data Integrity App

Direct & indirect system in Computer System Assurance

FDA new re-defined terminologies as Direct and Indirect system on the basis of the impact on patient safety, product quality and integrity

This change allows manufacturers to define testing strategy and apply critical thinking.

Let’s get familiar about systems and new testing terminologies:


  • ‘Direct System’ 

  • Direct systems have a direct impact on patient safety or product quality—like electronic device history , Laboratory Information Management or adverse event reporting—and may require increased testing based on risk.
  • In other words, the riskier a system impact is to the end-product and to the safety of the patient, the more testing and documentation is required.
  • (e.g. Inspects or dispositions product, labeling systems) will require testing based on risk, and expected deliverables are similar to current expectations, i.e. the riskier the application, the more testing and documentation is required.
  • ‘Indirect System' 
  • Is System that does not directly impact the product or patient safety but does impact the quality system (e.g. Document Control, Complaint Management, Lifecycle Management tools). The same rigor is not needed for the assurance of these types of systems and they require less documentation
  • Indirect systems do not have a direct impact on patient safety or product quality (for example, tools used in your CSV process like bug tracking systems or load testing and lifecycle management tools that do not directly impact the product). Indirect systems require less documentation.
  • Systems that are used “Out of the Box” may only require a Supplier Qualification and configured software may only require ad-hoc testing.

 

However, a hybrid approach could be acceptable.  Aim for better, more relevant testing. Consider what is the value of the documentation.

Computer System Assurance

• A Focus on testing for higher confidence in system performance.
• Risk based “Assurance”, applying the right level of rigor for a given level of risk to patient safety and/or product quality.
• “Take credit” for prior assurance activity and upstream/downstream risk controls.
• Focus on testing, not scripting. Use unscripted testing for low / medium risk components.

 

“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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