Hello Mr. Sridhar,
Thank you very much for your quick and on-time support for a complete Compliance Support, QMS and CSV support activity for CDS Server Infrastructure Qualification along with Standalone Instruments and also for providing Validated Excel Sheets for our QC lab.
Even though it is a sudden USFDA Audit and timelines were very short, your team completed the activity with-in the timelines, and I am happy with the way, you were personally involved along with your team for many days.
Our Production, Engineering, IT, QC and QA teams are delighted with the activity and your detailed guidance with proper Data Integrity Training for all the stake holders for additional 2 days.
Totally it is a well-executed activity with all the regulatory requirements as per USFDA 21 CFR Part 11, EU GMP Annex 11, ICH and GAMP 5 guidelines.
We wish this could give more further opportunities for strengthening our company with your continued association.
Head-QA, Emmennar Pharma
Dear Simpruv Team,
Well-done for a great job done for creating a well-defined network architecture and validating our facility lab CSV. Thanks for letting us the right approach and creating a right periodic review plan also to be in-line with current data integrity requirements.
AVP-QA , Smilax Laboratories
Dear Sridhar garu,
Thank you very much for extensive Training on Data Integrity, ALOCA Principles, Computer System Validation and Network Qualification. Your simplified methods of explanation and clarification helped us in coming with detailed approach of right Validation Plan, Deliverables and Workflow. Whole team is extremely satisfied the way you explained the Risk Assessment and Mitigation part which is the heart of Compliance and CSV. We were also able to identify the mistakes /improvement areas in our past activity and looking forward for a more secure IT architecture and Data Management in our facility.
Head-IT, Optimus Group
Dear Sridhar garu,
Thank you very much for your support during the Critical Customer audit of us on Priority. Your prompt action and guidelines for addressing 21CFR Part 11 issues as well as method Validation queries which helped in timely response to customer and resulted in successful outcome of Audit.
We thank your Compligrity validation team also for an Excellent ‘Computer System Validation (CSV) Documentation’ and ‘Designing & Validating the Excel Spread Sheets’ for our Lab.
I have to appreciate, the Validation activity was executed with a neat and clean approach with proper understanding of our requirements in the first meeting itself, and without much of my /our team intervention. Your Validations team even clarified all our doubts pertaining to CSV, GAMP 5 requirements also and really, I am amazed with the deep understanding of each of the team members on regulatory requirements being Software Engineersthough. Really a very commendable team and sound knowledge.
Thanks once again for all the sorts of support and being a 200% dependent Compliance & Data Integrity Specialists. Looking forward for more and more value addition activities form your side.
Head Analytical R&D, Progenerics Pharma
Subscribe to our Newsletter to get Important news and to keep up-to-date with our new Compliance Solutions and Services