Brief on Computerized System Validation
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- Опубліковано 21 чер 2020
- During this discussion, we will try to comply the requirements of 21CFR Part 11, EU GMP annex 11 and approach by GAMP guide. Further we will understand difference between GAMP4 & GAMP5 guide. We will have some practical insight on CSV during our discussion.
Dharmesh Mehta
Cadila, Sanofi,Zydus, AstraZeneca,Mylan,Interview Questions with Sharma Ji,ASK Mechnology,emainfo,Qualistery - GMP Content,easy medical device - Наука та технологія
Nice presentation
I would like to ask one question that is it necessary to take data back up recovery for production equipment which are linked to SCADA system. For QC instruments like HPLC, GC recovery is done for backed up data but for production it is difficult as checking we have to install or we have to copy that file into the equipment and then then only we are able to see that file. so please guide
Dear Pravinbhai, I understood your concern. But as per the requirement, you have to take back up of all GMP data so as to comply the Data Integrity Requirements, If you claim that, the paper record(e.g. BMR) is your original data. In such case, there may be possibility that, the in process parameters and other machine running parameters recorded manually in BMR or other GMP document may not exactly match with the data present in SCADA. This will lead to serious non conformance (Data Integrity issue). Hence, to safeguard the organisation, you can take the print and back up also so that, in future, you will able to prove that the print data is exactly matching with computerised data. Hope, this will clear your point. For further details, feel free to put your question again in comment box.
Thank you very much:) A very professional and encompass presentation on CSV. Great job 👍👍👍👍.
Thank you for your kind comments. Please be in touch.
Hi sir thank you for your explanation. I have one doubt.for example LIMS software is there and I need to implement the software in 12 sites. Please tell me can I do the qualification like RA,IQ,OQ,PQ for all 12 sites or only one site it is enough or all deliverables mentioned in above for all site required?. Can I perform only one site all above deliverables and remaining sites only PQ to be done is enough or not suggest me
I will prepare separate video for this
Very useful video sir... Thank you very much and keep posting.
So nice of you. Please keep learning !!!
Thank you sir for your valuable presentation.very useful for the interview preparation.
Hi Sir,
May i know for off-the shelf equipment come with software example: HPLC or UV
The software provided is it categorized as category 3?
If equipment qualification has been performed for the equipment itself, what kind of tests do i need to perform for the software?
For software - you need to perform so many tests - authorisations, windows controls, login and log out, data storage, data migration and many more..
Very well explained Sir! Thank you
sohail ahmad welcome 🙏🏻
Really Very useful info shared. Hats off! to you
So nice of you
Hello sir, I have one query, I have not work in pharma but in other science field. Can I still consider CSV as career option or prior experience in pharma industry is compulsory.
Prior exp. is not required. You need to understand the process flow and data management.
Sir in UV if my hardware belongs to UV probe but for database i. e software is labsolution then my software belongs to which category as per GAM5
The GAMP category should be identified by software vendor and not us as, we are not developed it.
Hello sir , does CSV comes under software engineering filed or non-software?
Your explanation is very good sir.
CSV is done to ensure its suitability for our GXP (GMP/GLP) purposes. Hence it is related to software engineering as well as user- Pharmaceutical companies.
It’s very informative session. Where I can get the recordings of your trainings. Also please share the links for the reference material again.
This session is conducted about couple of years back. So, I do not have it. You can prepare from the text of the video.
Can you please suggest to me in the PQ activity that time which below condition is preferred?
1. Commercial product or dummy product
2. Test server / QA server or Production server / On going server
PQ should be on the commercial product at the production level.
Thank you very much for sharing information with us
Welcome. Keep Learning !!!
thank you so much..How many sessions on CSV??
sir,i learnt testing tools like QTP and manual testing..is that subject related to CSV??..Now am working in QA API..
I will take one session first. After that, if required further, I will take another session. We will discuss about QTP testing also
Great presentation.Very informative.
Thank you so much for your kind comment
Hello Hitendra,
I would like to learn CSV as I am new to it.
My question is what is the first video where I can start following your videos.
Can you please let me know what’s the sequence.
You can go to the youtube channel - Hitendrakumar Shah --> Go to videos --> you will able to access all videos.
Hi sir, hope you are well..!! It was a very good presentation, thank you so much☺.
Can't able to download the presentation from link..??
The link was shared during the training. The link might have got expired.
Very nice presentation. Thank you
hi sir.. sofftware..let us take an example of Empower..is installed in laboratory for 5 HPLC..is it required to test all the computers and validated all the 5 systems in which the software is installed
Not required. But, the decision should be made based on QRM. Ensure all the systems same.
Hello sir, what a great presentation it is..
I didn't get the link on the screen , can you please share it me to download and learn from that presentation
The link was shared during the training on 1st day. Now the link will expire.
How done periodic review of validated computer system?
It depends on type of system, outcome fo QRM. You can check the performance, check and evaluate any changes and refer back to FRS &URS.
great Lecture.....i am still not clear on difference between computer system and computerized system can you pl. explain with examples
As per my understanding, there is any technical difference. Only the thing is many people use terminology - computer sytem - for hardware parts. While computerized system includes hardware as well as software of many be only software. If any software is being used by multiple peoples on different computer system, it is called computerized system. If any other thought you have please share. Thanks !!!
Hi Hitendra, Good session. Can you provide the list of deliverables in CSV and how it varies based on projects.?
If you want to understand deliverables, you need to go through the FDA part 11, EU GMP annex 11, Inspection readiness for computerised systems etc. I suggest, you can go through the different videos of the playlist. It will help you to understand in details.
ua-cam.com/video/BEqPpVDOCAU/v-deo.html
A software called document management system is installed in our organization and the vendor has done IQ OQ PQ and handed over the documents to us..Is the qualification sufficient or should we ask him to do CSV for the software..This is a customised software
The Qualification should be audited. The system should be audited. I suggest, you can go through short video
ua-cam.com/video/NhPgFEKKAW8/v-deo.html
I have one doubt sir, if the category 3 software is upgraded or updated to next version then the software will comes under which category sir please tell me
It depends on strategy of the organisation and type of software. It needs to be evaluated in detail then only I will able to provide you clear picture.
Suppose eresidue software is there for cleaning validation it is category 3 and it is upgraded with new version eresidue pro and tell me sir it is category 3 or 4
Category of the software is defined by the vendor as vendor is the SME of the software who has developed it.
Thanks for your valuable session,I have a question that difference between DQ and FS
I suggest, you can go through again the same video. You will clear the doubt. DQ- Design Qualification and FS- Functional specification
Sir after execution of one test in Operational qualification like display functions test I have taken screen shot on today ,and it's supporting appendix I will prepare tomorrow . Now on today execution of this display function test done by date will be today only after completion of display function test screen shots appendix preparation completion can I sign done date in that appendix as tomorrow
You need to ensure the activities are contemporaneous.
You can sign as Compiled by/Prepared By..
Thank you for the explanation sir, could you please tell me the difference between HMI,IPC and SCADA and how all these are linked to PLC
At this moment, I can tell you that, all these are computerised systems where automation and controlls are go on increasing from HMI to SCADA.
Hi sir, can we have a video on CSV to CSA approach and also about SAP ?
Yes, soon
Dear sir,
Requesting you , please make a session on area qualification of manufacturing areas
Sure. Will prepare video on area qualification
very nice explanation , thanks a lot
Thank you for your kind comments
Hi sir , I am doing MSc. Analytical chemistry I want to ask you doing this course will helpful for me in career ?
Yes. Definitely. Be in touch.
Hello sir, I've done a bachelor's degree in chemical(2017). I have a gap of 4 years since I've started my own business. Can I see this field as a career now?
Very much. Its emerging field and big scope
Thank you sir.@@hitendrakumarshah3718
It was well explained sir, but we need to know about 4 phases of CSV in detail.
Sure. Will prepare separate lecture
@@hitendrakumarshah3718 Thank you so much for sharing your knowledge. kudos to you. Were you able to prepare the lecture requested above? Thank you!
@hitendra is there any online training available from you
Yes
Very nice sir.....I want to ask a question is that can PQ be performed on commercial batches or not...if not so please suggest how ...an example for new blender in facility..we have to performed PQ for new blender....please reply sir
Yes. As per the guideline, you can perform PQ and PV simulatenously on same batch.
Ok thanks sir...can u provide guidelines reference for same.
@@rupeshrajput5560 "PQ should normally follow the successful completion of IQ and OQ. However, it
may in some cases be appropriate to perform it in conjunction with OQ or Process
Validation." EU Guide
Nicely explained Sir.. can you help me plz help me understand the GAMP categorization of applications like eDMS, eLMS, Trackwise and other SCADA based applications for operating the bioreactors and fermenters.
I suggst, you should not put more focus on categorisation. Because, it will not much impact on validation. Better you need to focus on risk assessemnt and identify the risk and risk tracebility matrix so that, you will not miss any important parameter or control.
Dear Sir,
I have 10 year experience in medical device and capital instrument sales.
I am looking job in IT Healthcare is CSV will helpful for me.
kindly suggest.
Yes sure
Thank you sir.
prasanna udupa welcome. Please keep learning 🙏🏻
Very nice presentation sir 👍
So nice of you !!!
Thank you sir,
How can we identify
whether system is computerized / non cimputeized?
If system is automated, data generated, stored and transferred directly from system, such system will be computerised system. For further clarification, please feel free to drop your questions in comment section.
if the system is connected to computerized software + System have particular SOP to run + System have trained person to run than its called computerized system. otherwise its just a random computer system.
@@denimpatel1940 No. Its not correct. A single standalone computer is also computerised system if we are performing GXP operations.
@@hitendrakumarshah3718 dear sir
Standalone system under GxP environment will have SOP nd train person to operate.
Correct me if i am wrong?
@@hitendrakumarshah3718 will you give example of stand alone Computer used for GxP operation without SOP nd trained person?
Sir I am btech mechanical, I want to ask this course helpful for my career?
Yes. Of course.
Kindly explain the difference between PLC validation and a workstation of any system directly connect with equipment
Good Point. I will prepare separate session on this.
I done my b.pharmacy i worked in some MNCS as analyst(US insurance billing)
Good. Good to know about this.
@@hitendrakumarshah3718 can I do this course sir, is am eligible...is it very tough course? Pls guide me sir
Hi Sir any video is there related to LIMS development and qualification
I will prepare separte video for LIMS implementation
@@hitendrakumarshah3718 Thank you Sir
Could you please define the traceability matrix with proper example which is required for computer system validation
The tracebility matrix means, the document where you are tracing and proving that the computerised system is functioning as per URS,FRS and respective QRM mitigation plan. Lets take example of URS - Which test is proving the compliance of specific URS point. That tracebility number should be provided. Hope it is clear to you.
Thank you sir,
Your explanation was very simple and clear.
Could you share the documents link ..?
Sure. Please confirm for which document, you need link. I suggest to go through below link to access all recorded videos and webinars.
ua-cam.com/channels/rWoNI0Xsq0_2ZH3UZCXTMg.html?view_as=subscriber
@@hitendrakumarshah3718 Thank you sir.. Could you please explain the types of validation ?
@@Israel_N_123 Hope you are asking about computerised system validation. Do you mean type of testing or types of validation models or types of validation like hardware validation and software validation. Can you please provide more clarity about this question.
@@hitendrakumarshah3718 Types of validation models ?
@@Israel_N_123 mostly 2 types
1. Retrospective which for system in use.
2. Prospective for new implemented system.
Is SAT and FAT done for software as per GAMP5
Yes. FAT and SAT should performed.
Thank you👍👍
Welcome !!!
Hi im having 8 yer experience in Phrma helathcare. I need to learn the Coures how can o enroll this coures?
I am going to organise the training. Will confirm you once finalised. Will share you details.
@@hitendrakumarshah3718 I have 6 year of experience in QA please let me know in the course.
@@nishachalak519 please connect to Blutech media.
Ashish Chauhan- +91 99871 21607,
+91 77188 43607
Or Piu +91 98675 14145
who can help provide a so easy example to explain what the closed system and open system is, please
Closed in under your control, open is not under your control. For example, whatsapp is open system. While CDS with inhouse server is closed system
Many doubt cleared thanx
Welcome. Keep Learning !!!
Hi Sir, Could you please share me the document link of this presentation?
Hi, you can go through the link only. As, after training, i just go on modifying the existing one for next training. this ensures that all my training session are different from each other.
Went through that link, it says document unavailable
@@HARSHAVARDHAN-vs7lm Which link. Can you please clarify your question. Thanks.
The one in the video
@@HARSHAVARDHAN-vs7lm Sorry. I am not finding. Can you please tell me time slot. Thanks
Awesome sir.. Thanks
Thank you so much for your comment. Please be in touch.
Please sir share ur number if u don't mind
@@the.Higher.Self.0 My all contact details in last slide. You can reach me at 8689981962. If you want to ask questions, I suggest, you post here in youtube only. I will revert to you.
Thnx sir..
sir i am interested in course on csv if you are providing. Kindly reply.
We are organising the different training sessions. I am putting in the posts of the youtube.
Very nicely taught
Thank you so much for your kind comment !!!
I don't know why you are speaking about the environmental conditions in IQ while you are talking about software validation. How humidity, temperature, and air affect the software installation? The idea about the Functional specification has caused enough trouble for my existing knowledge. I was aware that the FS is provided by the vendor and there is a DQ part to qualify the vendor among the competitors.
Yes. Environmental conditions plays very important role. That has to be evaluated.
@@hitendrakumarshah3718 in CSV?
Please generate the clarity ISPE have plan to convert CSV in CSA
Sure. Will have that discussion also
Do your course present in udemy?
yes
Valuable information
Thanks
Sir I’m an mca fresher ,can I learn this course to get a job
Yes. Definitely. Now the CSV and automation topic is very Hot and many are making their career in this Topic.
Hitendrakumar Shah can u suggest me how to start bro.Is there any learning sites or institutes
Super sir
Welcome. Keep Learning !!!
Hi Sir,
It is a best video about CSV which simplified the complexity.
Could you please let me know, whether Melting point apparatus used in QC, which is not compliance with CFR 11, comes under the scope of CSV.
I suggest, you can refer video on 21 CFR part 11 for details.
@@hitendrakumarshah3718 Thanks sir
What is alcoa plus
As, you can go throgh complete learning package for data integrity through the link below. You will get details.
ua-cam.com/play/PLq7ln35Rt1rMErZ7X4wgu5NyddOZIAICi.html
please make a video on ICH Q6 guideline
Sure. Thanks
Voice and presentations lgood
Thank you for your kind confirmation
Good sir
Thanks and welcome
Which mylan pithampur or other
I was in Ahmedabad
Very good
Thanks
Very much experience
Thank you so much
CSV need software skills??
No. CSV basically needs basics of operation and controls.
Sir nice video..but kya aap esko hindi m bana skte ho
Sure. Let me try
Please explain resikassement
I will take separate session of QRM. However meanwhile, you can go through the link to have brief understanding about QRM. Link: ua-cam.com/video/Egkk6AoJSvg/v-deo.html
Ok
OK
All cds falls into Gamp4 category.
They normally consider as GAMP 3. As, there are also changes on routine basis.
everything is ok
Thanks for confirmation
👍👍👍👍👍👍
Arun Thakur Thank you so much🙏🏻
Sir, I am Prasad, PLC, SCADA which category
It depends on what is nature? How is built?
Such good stuff here but almost impossible to understand. Very unfortunate.
What is the problem you are facing? I can help you out. Thanks !!!
Hello sir
Hello
hello sir, great video great information, can I get your email id if I want to reach out to you. thanks.
My email ID is in video itself. You can reach me at nadhgmp@gmail.com