CSV stands for Computer Systems Validation. It is the process used by pharmaceutical companies to test, validate and formally confirm that a computer-based system does the job it was made for.
Most importantly, CSV confirms that a computer system is secure, reliable and accurate. And, as we know, this is extremely important for any pharmaceutical company!
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:
- Laboratory work
- Clinical trials
- Product manufacturing and testing
- Drug development
- FMCG operations
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.
Find CSV Engineer Jobs with Hyper Recruitment Solutions
There's no denying that most things in life are becoming increasingly automated. Due to this, the need for Computer Systems Validation Engineers is on the rise, and this shows no sign of stopping any time soon.
Salaries are extremely competitive in this field due to the niche level of expertise involved within this pharmaceutical role, so you'll be financially rewarded for your knowledge.
If you have an interest in computer systems and a pharmaceutical qualification, then CSV may be the career for you.
Click the link below or contact us to browse the latest vacancies from innovative sectors and businesses all over the UK.
Relocating to the US for your pharmaceutical career
If you'll be relocating to the US from another country, you may need a work visa.
The specific type of visa you need will depend on your country of origin, the company's needs and whether the employment is permanent or a temporary assignment. Your prospective employer will discuss this with you.
If you're looking for a career in the pharma industry, HRS can help! We work with top pharmaceutical employers on both sides of the Atlantic to find the right people for a range of different roles. Use the links below to browse the latest vacancies, or enquire now for more information.
