Need of Computer System Assurance

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 instead of fear of putting a poor-quality product on the market.

For software not used in a product, manufacturers are referring to burdensome guidance that is more than 20 years old, trying to avoid FDA Form 483 observations and warning letters from FDA investigations and third-party consultants.

Nothing should be done for fear of regulatory observations. Instead, the focus should be on testing for higher confidence in system performance and applying the right risk-based assurance rigor for a given level of risk to patient safety and product quality.

In process of addressing this issue, the US FDA launched Case for Quality Program in 2011 following an in-depth review to understand the barriers for Medical Device quality.

The “Case for Quality” helps to understand the gaps between the USFDA expectations and industry practices. This report lays down the improvements from the industry and from the USFDA to align with each other to focus on Product quality and Patient safety.

In the Year 2015, USFDA in coordination with Siemens-Fresenius executive exchange identified computerized system validation process as a barrier to implement technologies across the pharmaceutical and health care industries.

Later, in the Year 2016, an industry working team was formed for development and establishment of Computer System assurance program across the industries

The new CSA framework also enables manufacturers to “take credit” for prior assurance activity and upstream and downstream risk controls like vendor qualifications.

While the promise of simplified, less costly validation is exciting, many pharmaceutical companies are confused about how to interpret and adopt the new methodology.

After all, computer system validation regulations haven't changed in over two decades.


 “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

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