I am quite new to the concept of CSV and have no experience whatsoever in the pharma industry. Need some guidance on CSV.
What is CSV and is it a part of 21 CFR Part 11 compliance?
Does CSV include GxP Assessment, 21 CFR Part 11 coverage assessment, 21 CFR Part 11 gap analysis?
The risk based CSV approach (as per GAMP 5) – does it mean a risk analysis is a must prior to validating a system? If yes, is there a site where I can find some templates for reference.
What are the parameters that are considered for risk assessment? - Probability of failure, Impact… is there anything else to be considered?
SOPs - is there some place that i can find any standard SOPs for reference?
What are the penalties of non-compliance?
Places where I have read up mention “certify system” - who certifies the system as compliant? is it the vendor who does the validation or FDA or any other body?
What happens if the systems are not validaed?
Appreicate it if you could help with this.
Thanks
Sangeeta
1 - CSV is the term used for Computer System Validation (or sometimes Control System Validation). The requirements of 21CFR Part 11 are a part of CSV but not all. 21CFR purely deals with the FDA’s requirements around how Electronic Data and Electronic Signatures are used (if at all) and the security/integrity of those records. A computer system within a manufacturing environment does a lot more than simply record data and when records are signed, and maintain a secure audit trail. It is the job of CSV to test those systems and all their product critical functions, demonstrating accuracy and consistency of result.
2 - Yes, yes and…yes.
3 - GAMP is a guideline it is not prescriptive. The ‘risk-based’ approach is designed to respond to criticism that validation is over-bearing and sometimes unecessary. The idea of the risk based approach is to encourage only critical functions/features of a system are tested to a unit level. Performing a risk assessment up front may reduce (or sometimes eliminate) the validation requirement.
4 - Likelihood x Impact = level of testing required.
5 - Do you mean like a ‘how to’ guide?
6 - Depends upon the level of non-compliance and the effect it has had. Ranging from getting a grilling in an audit and being made to feel pretty stupid, right up to prison and limitless fine (very unlikely).
7 - Usually the author of the validation report will certify the system (in the validation report) and, approvers of the report sign up to that.
8 - No product gets released. If it does then you will find yourself in a whole heap of trouble come next audit.
CSV is a comma-separated values file is used for the digital storage of data structured in a table of lists form, where each associated item (member) in a group is in association with others also separated by the commas of its set. Each line in the CSV file corresponds to a row in the table. Within a line, fields are separated by commas, each field belonging to one table column. Since it is a common and simple file format, CSV files are often used for moving tabular data between two different computer programs, for example between a database program and a spreadsheet program
That is indeed what Wikipedia says if you put ‘CSV’ in. However, in the context of the forum (and pharmaceutical manufacturing) CSV is Computer System Validation.
CSV stands for Comma Separated Values, sometimes also called Comma Delimited. A CSV file is a specially formatted plain text file which stores spreadsheet or basic database-style information in a very simple format, with one record on each line, and each field within that record separated by a comma. It’s important that the individual “records” within a CSV file NOT contain commas, as this may break the simple formatting when using the file in another application.
CSV files are often used as a simple way to transfer a large volume of spreadsheet or database information between programs, without worring about special file types. For example, transferring a home-made address book from Excel into a database program such as Filemaker Pro could be done by exporting the file as a CSV from Excel, then importing that CSV into Filemaker.
Creating a CSV file from spreadsheet data is very simple to do using Microsoft Excel.
Open your spreadsheet document and go to the File pull-down menu (or the Windows/Office round button menu in Office 2007), and choose Save As…
Change the “Save as type” or “Format” field to read: “CSV (Comma delimited)”.
Enter a name for the document and click Save.
To check the validity of your CSV file, open the new file from a plain-text reading program such as Notepad or TextEdit. Check to make sure there are no extra commas, other than between fields. Depending on what program you’re going to use the CSV file with, you may need to also remove any extra quotation marks or other formatting which Excel may have inserted.
Hi,
Now Computer System Validation
is the one of the most important aspects in validation of Equipments,
specially critical equipments i.e compression m/c,blister packing machine,RMG,FBD etc.
coz in CSV there are major components like,PLC (programmable Logic Controller, Password protection system,software installed ,BAck up facility (audit trail).
and its requirments are given 21 CFR part 11 electronic records and also in GAMP-4.
Regards
Prasad Aparajit prasadaparajit@rediffmail.com
Torrent
1 - CSV is the term used for Computer System Validation (or sometimes Control System Validation). The requirements of 21CFR Part 11 are a part of CSV but not all. 21CFR purely deals with the FDA’s requirements around how Electronic Data and Electronic Signatures are used (if at all) and the security/integrity of those records. A computer system within a manufacturing environment does a lot more than simply record data and when records are signed, and maintain a secure audit trail. It is the job of CSV to test those systems and all their product critical functions, demonstrating accuracy and consistency of result.
2 - Yes, yes and…yes.
3 - GAMP is a guideline it is not prescriptive. The ‘risk-based’ approach is designed to respond to criticism that validation is over-bearing and sometimes unecessary. The idea of the risk based approach is to encourage only critical functions/features of a system are tested to a unit level. Performing a risk assessment up front may reduce (or sometimes eliminate) the validation requirement.
4 - Likelihood x Impact = level of testing required.
5 - Do you mean like a ‘how to’ guide?
6 - Depends upon the level of non-compliance and the effect it has had. Ranging from getting a grilling in an audit and being made to feel pretty stupid, right up to prison and limitless fine (very unlikely).
7 - Usually the author of the validation report will certify the system (in the validation report) and, approvers of the report sign up to that.
8 - No product gets released. If it does then you will find yourself in a whole heap of trouble come next audit.
very interesting thread…I read all post related to this topic and enjoyed all post…It helps to provide clear understanding of CSV.The COMPUTER validation process begins with the system proposal/requirements definition and continues until system retirement and retention of the e-records based on regulatory rules.