History of Computer System Assurance

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

Regulations exist all over the world for the protection and safety of consumers. They serve a vital purpose in economies and societies and are depended on by practically every individual in the world in some way, shape or form.

Without any or with little regulations, consumers would be at a great risk, with their safety jeopardized and no way of determining whether or not a product is able to perform as marketed.

When it comes to products directly affecting the health and well-being of a consumer, the regulations generally become more stringent, as the quality of the product and safety of the patient are paramount.

The FDA’s regulation 21 CFR Part 11 in 1997 and the related guidance of 2003 created the clear foundation for implementation of Computer System Validation (CSV) processes.

Adhering to FDA CSV guidance can be a challenge for life science organizations, however. CSV guidelines prioritize documentation, primarily to appease auditors, which can be both time-consuming and costly.

This emphasis on documentation impedes the application of critical thinking during the validation process, along with opportunities to improve automation via system modernization.

To address these issues, the CDRH, in collaboration with the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), is planning to release a new guidance document entitled Computer Software Assurance for Manufacturing and Quality System Software. 

As the FDA advised manufacturers to take a proactive stance in their approach to the new CSA methodology. This should focus on patient safety, product quality, and data integrity.

Those who take this proactive approach will be part of an innovative new system, putting the needs of their patients first by developing high-quality products in a timely manner. Conversely, those who fail to take this approach may run the risk of falling behind in the race to market.

This guidance will create opportunities for streamlining documentation by shifting the focus of CSV processes towards critical thinking, risk management, patient and product safety, data integrity, and quality assurance.

FDA decided to partner with industry to strike a balance between promoting automation and value-add CSV activities. 

The FDA has advised life sciences companies to take a risk-based, least burdensome approach to CSV for two decades

The FDA aimed to improve quality, remove non-value add activities, and focus testing on high risk areas, therefore reducing validation cost and time by focusing on the software’s impact to patient safety, impact to product quality, and impact to quality system integrity (Direct or Indirect system). 

Too often, testers spend time ensuring their protocol is error free, as opposed to spending time on automated solutions that verify the software meets it’s intended use

Burdensome, documentation heavy CSV approaches have been a deterrent to faster technology adoption in Life Sciences industry.

CSA truly walks the walk of risk based computer system validation. It advocates leveraging documentation from trusted vendors, reducing documentation burden and viewing technology as a risk reducing enabler.

“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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