Comparison CSV Vs CSA

Data Integrity App


 “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” William A. Foster


Focus on creating documentary records for compliance 

                                                VS 

Focus on testing for higher confidence in system performance


Validating everything with the risk to miss higher risk functionality 

                                                VS 

Risk-based assurance, applying the right level of risk to patient safety and/or product quality


Ignoring previous assurance activity or related risk controls 

                                                VS 

Taking prior assurance activities into account and upstream / downstream risk controls


CSV is ‘’a confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that particular requirements implemented through software can be consistently fulfilled’’. This implies that in the industry, a validation approach results in an extensive set of test and other documents.

CSA proposes “a set of activities or actions to be performed to give confidence that the software functions as intended and meets the organization’s needs’’.

These activities can include solution selection analysis, vendor history and data (which can be reused!), market performance data, installation activities, factory acceptance and risk-based testing.

 

What is the difference between computer system validation (CSV) and computer software assurance (CSA)? 

If you think of the 80/20 rule, the current CSV methodology has manufacturers spending 80% of their time documenting and only 20% of their time testing.

The FDA wants to flip this so that 80% of a manufacturer’s time is spent on critical thinking and applying the right level of testing to higher-risk activities, while only 20% of their time is spent documenting (CSA methodology). This critical thinking should be focused on three questions:

  • Does this software impact patient safety?
  • Does this software impact product quality?
  • Does this software impact system integrity?

 

Using a risk-based approach is nothing new, and regulatory agencies such as the International Society for Pharmaceutical Engineering (ISPE) who author Good Automated Manufacturing Practice (GAMP®) have been advocating this for two decades.

CSA is a framework designed to help manufacturers achieve CSV. CSA will provide clarity on the stance and methodology used to determine what is high risk and what is not, therefore minimizing misinterpretation by manufacturers.

The clarification in the CSA approach flips the paradigm to focus on critical thinking (risk-based), assurance needs, testing activities, and documentation, in that order.

 

Computer System Validation 

Computer system validation procedures emphasize elaborate documentation requirements to ensure auditors have a detailed overview of all aspects of applications being used to manufacture a product.

Instead of assuring product quality, these extensive documentation requirements have become somewhat of a bottleneck and a burden to life science companies, effectively deterring investment in more automated IT solutions.

 Computer software validation (CSV) as defined by the FDA is a documented process to demonstrate that computer software works according to its intended design.

 

Computer System Assurance 

The new CSA guidelines are the FDA’s attempt to rectify this problem, emphasizing patient safety, product quality, risk control, and critical thinking, which is a major reorientation of the previous CSV framework.

Instead of having documentation at the forefront like CSV, the CSA flips this structure completely and establishes critical thinking as its principal phase.

Computer software assurance (CSA) is a risk-based approach that limits testing to functions directly impacting product quality and patient safety. CSA also encourages companies to use the software vendor’s documentation to reduce the testing burden and deploy applications faster.

 

Benefits that can be realized from this new approach include reduced software development and implementation times, reduced costs, reduced documentation, and more effective software systems.

 

As the FDA prepares to release its new CSA guidance, life science companies need to be proactive and develop a strategy to transition to the new CSA methodology that focuses on patient safety, product quality, and data integrity.


 “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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