What is CSA?

Data Integrity App

 

What is CSA?

The most obvious question is: What is CSA, and how does it differ from traditional CSV? The current process, CSV, focuses on producing accurate, approved documentation to present to auditors, then testing, then assurance needs, and finally critical thinking.

The CSA methodology is the exact opposite; it flips the paradigm. It emphasizes critical thinking (risk-based), assurance needs, testing activities, and documentation, in that order. In a nutshell, the goal of CSA is to "right-size" validation activities, placing the focus on what directly impacts patients or product quality

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.

The objective of the CSA guidance is to promote critical thinking, more testing of the system’s intended use, and less functionality testing.

CSA aims to reduce unnecessary documentation whilst still assuring that the software is fit for purpose and that any risks are mitigated. This new approach will focus on:

• Critical thinking: Risk definition for each software feature
• Assurance: Demonstrate if the feature and functionality is working as desired
• Testing activities: Leverage and define the different test methods like scripted and unscripted testing.

 

Why the shift?

The speed and efficiency of computer software validation (CSV) has emerged as a key focus over recent years, with the FDA set to release their new approach: Computer Software Assurance 

In a word: overkill. In 1997, the FDA issued 21 CFR Part 11, which specifies how FDA-regulated companies must manage electronic records and signatures. The Agency’s intentionally vague instructions led to overwork, costing the industry millions of dollars.

Five years later, the FDA released a related guidance advising regulated companies to take a least burdensome approach and integrate software management and risk management, laying the foundation for CSV.

Unfortunately, the 2002 guidance has not solved the problem. Companies continue to generate copious amounts of documentation, primarily to appease auditors.

 

This focus on documentation impedes critical thinking and the use of automation and modern technologies to enable more effective testing.

 

One of the key findings of the initiative was that Computer Software Validation (CSV) had become a burden for life science companies.

CSV seemed to have shifted the industry's focus to passing audits with extensive documentation requirements. They also found that less time and effort was spent concentrating on quality.

Most companies have been deterred from investing in automated systems due to the frustrations that come with CSV. For the past two decades, CSV has remained mostly unchanged. However, with the advances in software (which have been elevated due to the pandemic), the FDA must now bridge the gap between regulation and technology.

What’s the FDA looking for?

Although there are subtle differences between CSV and CSA, such as ad hoc testing, CSA still promotes a risk-based, least burdensome approach consistent with the 2002 guidance.

 

In reality, the FDA isn’t asking us to do something that’s incredibly different from what we’re doing now. They’re just asking us to do it better by putting critical thinking at the forefront and leveraging the powerful technology tools we have at our disposal.

The FDA’s new approach to CSV, Computer Software Assurance (CSA), represents a step-change in computer system validation, placing critical thinking at the centre of the CSV process, as opposed to a traditional almost one size fits all approach.

FDA intends to focus on direct impact systems and not on indirect systems. The change allows manufacturers to focus testing rigor on areas that directly impact patient safety and device quality, as:

 

 key principles of CSA:

• Use the skills, experience and prior work form all key stakeholders to minimize current and future work
• Treat vendors as partners and make more use of their previous development and testing efforts
• Use the above risk assessments to justify levels of testing (ie. formal scripts, high-level cases, ad-hoc tests) against requirements and design elements
• Do not repeat verification and testing exercises
• All documentation produced must add value to the project/support of the system

 

 “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.