Why Do We Use CSV in Pharma?
Everything that goes on within a pharmaceutical company is monitored, accounted for and intensely regulated. When you deal with the production of medicines, drugs and life-changing equipment, everything needs to be done by the book.
This is why CSV is so essential. Computer Systems Validation allows all data to be legally regulated by providing a reliable and legally sound data trail.
It's best to see CSV as the digital version of a written signature on a document. CSV gives companies and the regulatory bodies accuracy, reliability and enhanced data integrity.
Where Would You Use CSV in Pharma?
CSV is used in any sector of pharma where electronic data needs to be stored. As you can imagine, this includes a lot of sectors!
Most commonly, CSV is used in pharma for:
- Product manufacturing and testing
It's also important to note that CSV is used as an ongoing process in multiple life science sectors to ensure the validity and reliability of any data that is stored electronically.
How Do You Validate a Computer System?
To carry out the CSV process, you will need to follow the GAMP® 5 guidelines that cover the four life cycle phases of a computer system and how to reliably validate them.
As a CSV engineer, you will work around the following 4 phases of CSV:
Concept
An overview of the system and design considerations of the computer equipment.
Project
A detailed description of the system itself and its objectives.
Operation
How the system and its data will be managed during operation.
Retirement
How to retire the system once its data is no longer required.
There is, of course, a lot more involved when you become a CSV engineer. Extra responsibilities may include: risk management, document management, repairs and security management.
