Introduction In the era of Pharma 4.0, the transition from paper-based systems to digital automation is no longer optional. However, for those of us working in Sterile Injectables , this shift brings a unique set of regulatory challenges. Drawing from 11+ years of experience in USFDA, MHRA, and WHO audited facilities, this article explores the critical intersection of GAMP 5 methodology and 21 CFR Part 11 regulations. 1. The "What" vs. The "How": 21 CFR Part 11 and GAMP 5 It is essential to distinguish between regulation and methodology: 21 CFR Part 11 (The Regulation): This FDA rule defines the requirements for electronic records and signatures to be considered trustworthy and equivalent to paper. GAMP 5 (The Methodology): This provides a risk-based framework—the "How-to"—for achieving compliant computerized systems. 2. Key Pillars of CSV Compliance Based on my experience leading CSV projects in FFS (Form-Fill-Seal) lines at...
- Get link
- X
- Other Apps















Thank you Yunus, for spending your precious time on my Blog Techreviews. https://pdtechreviews.blogspot.com/. This blog was prepared for reviews of webhosting, blogging seo tips and guidance for blogging.
ReplyDeleteDefinitely I will also visit your site. Again thannk you for reaching here... Keep reading my latest posts and subscribe if you like.
Great Blog! That was amazing. Your thought processing is wonderful. The way you tell the thing is awesome.
ReplyDeleteGet best shared hosting from Glasta with unlimited disk space & data transfer, 100% uptime, free domain and more with this shared web hosting package.
Thanks a lot for visiting blog https://pdtechreviews.blogspot.com/. I love to write on web hosting services, blogger tips, blogger seo tips, search engine optimization. Definitely I will also visit your site and will check for the web hosting best plans offer.
DeleteThis comment has been removed by the author.
ReplyDeletebest web hosting providers It is actually vital to decide on a trusted host company to make certain that your site remains safe and accessible all year round. If you are experiencing problems with your existing provider or have no tip what needs/features to think about it.
ReplyDeleteReally good article. You mention almost every point. Worth to read . Thank you
ReplyDeleteWeb Hosting in India
Nice read! Very informative. Something interesting
ReplyDeleteweb hosting in dubai
Nice post !! I really enjoyed your well written article thanks for share....
ReplyDeleteWeb Hosting in Bangladesh
Nice read! Very informative. Something interesting
ReplyDeleteWeb Hosting in UAE
Best web hosting Canada
ReplyDeletePro Website Hosting | Domain names & web hosting company offers domain name registration, web hosting, reseller hosting and SSL certificate for privacy protection. Enquire now.
A really great selection of blogs!
ReplyDeleteWeb Hosting in India
I like content very much. Clean and true hints. Thanks
ReplyDeleteBusiness Web hosting in Pakistan
great article. One can also read top 10 web hosting companies of 2020 here. It might be helpful to select your web hosting company.
ReplyDeleteAccording to my knowledge. Name cheap is the best hosting provider. More hosting provider we can get to know about from your blog. As well, most companies does not about our Best moving companies in Ridgefield CT. I hope they will approach us and get our service.
ReplyDeleteNow, we can get to know about the best hosting provider for our domain.
ReplyDeleteTech news Digital Marketing in Dubai Website link logo design dubai
Best web hosting Canada
ReplyDeleteOptidigital : get best web hosting service in Canada. We offer the best web hosting service. Choose web hosting for your personal and professional websites.