Transitioning from CSV to CSA

 

Data Integrity App

Transitioning from CSV to CSA

 

Too often, process changes like CSA are pasted on top of existing procedures, without taking full advantage of the potential benefits.

 

Though not yet officially released, the CSA concept is already leading to exciting changes in workflow and policy at leading medical device companies.

 

  • Change the culture from of your organization from a compliance-centric mindset to quality-focused culture.
  • Leverage your software suppliers existing activities (perform supplier audits)
  • Consider using computer system validation tools to automate assurance activities
  • Know the intended use of your computer system(s).
  • Know the high-risk features, operations, and functions of the computer system(s).
  • Review and update your current policies to align with the CSA approach.
  • Know the existing gaps in your current validations.
  • Have a plan to close the gaps.

 

 

A few key best practices for facilitating the transition from CSV to CSA methodology include:

 

Perform a validation assessment. 

To best take advantage of the new CSA guidance, you need to assess your current environment.

 

How much time are you currently spending planning, designing, testing, documenting, etc.? Document your current validation processes, resource utilization, and gaps with CSA methodology.

 

Develop a transition plan. 

Now that you have documented your current environment, you can develop a transition plan that focuses on key aspects of the CSA approach – new streamlined validation processes, critical thinking, product quality, patient safety, data integrity, operational efficiency, and effectiveness.

 

This should include quantifiable metrics that allow you to measure your operational performance (e.g., costs, time spent on validation, etc.).

 

Audit your vendors. 

Audit your vendors to determine the quality and availability of their validation documentation. This can allow you to begin using vendor documentation to satisfy regulatory requirements for appropriate medium and low risk systems.

 


Develop a change management plan. 

You cannot accomplish an effective transition to CSA without supporting your people to make the change.

 

You’ll want to put communication and training programs in place to support changing the culture of your organization from a compliance-centric mindset to quality-focused culture.

 

These programs will support your team in understanding key CSA concepts like critical thinking, risk-based approach, product quality, patient safety, data integrity, value-add activities, etc.

 

Once the guidance is officially released, the details will become clearer on how best to implement the CSA methodology. Until then, check the CDRH website for the latest updates.


 “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.

 

Comments

Post a Comment

Popular posts from this blog

Need of Computer System Assurance

Image
Data Integrity App   Why is the FDA making this change? Over the last decade, innovation and technology has emerged with tremendous speed and brought the industrial revolution (Industry 4.0) through smart manufacturing and automations. The Pharmaceutical industry has adopted most of the technological innovations such as Artificial Intelligence and Machine learning, Big Data & Analytics, cloud computing, Robotic Process Automation, 3D Printing, Virtual Reality and Augmented Reality, IoT (Internet of Things) and Tele radiology, etc. which is now known as Pharma 4.0. The traditional computerized system validation process was conceptualized prior to this technology evolution and being updated to some extent but is not able to cope up with industry expectations. The lack of expertise, understanding of the technology and over thinking makes the traditional computerized system validation process as prolonged activity. Too much work is done for fear of regulatory punishment i...
Read more

Industry Common CSV Pain Points

Image
Data Integrity App Industry Common CSV Pain Points USFDA and Industry working group of Computer System Assurance (CSA) identified the common pain points of the industry in implementation of new technologies with traditional CSV methodology I Deterrent to pursuing automation:  The volume of documentation and complex process of computerized system validation deter the rate of investment (ROI) on implementation of new technologies and automation. II. Gathering evidence for auditors:  The lack of knowledge and understanding on the regulatory expectations on CSV forced the industry to collect the evidence for each function in the computer system beyond the intended scope to please the auditors. This process of gathering the evidence doubles the CSV process implementation time. III. Duplication of vendor efforts at client sites:   The failure in exploring the product and supplier maturity and inexperience in communication with vendor results in customer to repeat the ac...
Read more

Current approach to Computer System Validation (CSV)

Image
  Data Integrity App The focus of current CSV processes is producing accurate and approved documentation to present information to auditors. Auditors, such as the FDA, require evidence and records, therefore the CSV methodology inspires a compliance-mindset rather than an innovative one. As such, existing CSV methodology results in manufacturers spending around 80% of their time producing documentation and only 20% of their time doing actual testing of the software. CSV has morphed into an activity that is being done primarily to secure evidence for auditors, rather than to assure the quality of systems being validated. The current CSV approach is seen as: Deterrent to pursuing automation time, cost, use of automated testing tools, documentation generation etc Regulatory burden (e.g., Data integrity) as an excuse for resisting progress; meanwhile, other regulated and nonregulated industries have moved forward and adopted frameworks for modern testing. All software...
Read more