Скачать или смотреть What is the importance of Data integrity in the pharmaceutical industry?

What is the importance of Data integrity in the pharmaceutical industry?
You are watching 90 days challenge of learning with Blue Ocean Compliance. In these 90 days we are discussing the critical non-compliances done by the pharmaceutical companies which caused getting them Warning Letter issued by USFDA.
Now we have started Data Integrity series in this 90 days challenge. In day 16th we discussed the ALCOA, ALCOA+, and ALCOA++. Today we shall discuss the importance of Data Integrity and about the warning letters given because of violation of 21CFR 211.68.
Once I was talking to one manufacturer and founder of the pharma company. They asked me why we got WL? We feel that we do not have competent and knowledgeable people. I gone through their WL and understood the fact and expressed my views. The reason of getting the WL was not the lack of competency or lack of knowledge. But the reason was violation of data integrity principles. You will find that most of the WLs are issued for DI issues.
If you have DI issues, then it's an invitation for WL/ serious non-compliances. I hope this fact suffices to make you understand the DI importance.
Now let's discuss the 21 CFR 211.68. It is for Automatic, mechanical, and electronic equipment.
These may be computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product.
The observation was “Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).”
1. Stand-alone gas chromatogram (GC) computer system lacked appropriate controls, such as an audit trail and individual log-in access to prevent the deletion of data.
2. Investigators found numerous analysis reports, test methods, raw data calibration, and system directories in the GC computer’s recycling bin.
3. The laboratory personnel used a shared password, located in an unsecured drawer, to access the GC software.
4. No systems for access levels, access privileges, or authorized users to perform the analyses, collect data, review data, or perform other functions.
5. No system or assurance the integrity of the data generated by the computerized systems in the interim, prior to the full implementation of their corrections.
6. It is essential that your firm keep track of all changes made to your electronic data.
These were today’s learnings.
Stay tuned to get more.
Stay connected to receive the magic!
Stay in touch to grow limitless!
Do not forget to subscribe to my YT channel.
Soon will announce something great!
_______________________________________

Dr. Rupali Paranjape
Auditor, Trainer & Mentor for Pharma Companies & Professionals
📧 [email protected]
🌐 www.drrupaliparanjape.com

Blue Ocean of Compliance
Holistic Approach Towards Achieving Regulatory Compliance for Pharmaceutical Industries with No-Observation
________________________________
Blue Ocean of Compliance
Holistic Approach Towards Achieving Regulatory Compliance for Pharmaceutical Industries with No-Observation

Are you struggling to solve the problems of non-compliances on your site?
Even with putting your best technologies, Knowledge, and efforts do you feel clueless?
If you want to protect your site from risks & huge losses due to non-compliances,
If you want to know the thought process & path which would lead you to qualify a Regulatory Inspection with no-observation in a cost-effective way,
Then do not miss "Blue Ocean of Compliance" #1 Best Seller book on Amazon by Dr. Rupali Paranjape.

Why you must read this

👉By reading & implementing this you will be able to avoid more than 492, 483s on your site.
👉You will be able to avoid many circumstances that lead to Warning letters.
👉You will become more familiar with the enforcement actions, reasons of non-compliances & ways to overcome them in cost-effective ways.
👉You will come to know many factors which might not be discussed before to solve the non-compliance issues on the site.
👉You will know one new thought process “Blue Ocean of Compliance”
👉At the end of each Chapter Practical Assignments: Exercise is given for implementation.

The beautiful part of the book is, that it is written by an experienced doer that has spent years on the shop floor in a very simple manner, in easily understandable language with examples, case studies, 492 FDA 483 observations, and many Warning Letter Case studies and much more.
You may buy this book from amazon in India & globally.

To book your copy click the below link;
For India;
Blue Ocean of Compliance https://amzn.in/9CNUVoz

Out of India, you may book your copy from amazon.com.
Blue Ocean of Compliance https://a.co/d/fu1fhjs
_____________________________________________