What is CSV, Its Need, Purpose & Benefits in pharma Industry.
The concept of validation was derived from engineering principles of validation
of mechanical system that has been extended to the software industry. To extend
it further during mid-1970’s, Ted Byers and Bud Loftus, two Food and Drug
Administration (FDA) officials first proposed the concept of validation in order
to improve the quality of pharmaceuticals (Agalloco 1995).
In 1987 the FDA
published a document entitled ‘FDA Guidelines on General Principles of Process
Validation’.
It state that
"Process validation is establishing documented evidence which provides a
high degree of assurance that a specific process will consistently produce a
product meeting its predetermined specifications and quality attributes."
Feeling the necessity of Validation, FDA published a guide to the inspection of
Computerized Systems in Pharmaceutical Processing, also known as the ‘bluebook’
(FDA 1983).
For MHRA this is Annex 11 of the EU GMP regulations (EMEA 1998),
whereas for American FDA, this is 21 CFR Part 11 for rules on the use of
electronic records, electronic signatures (FDA 1997).
What is CSV?
According to
both American FDA and UK MHRA, computer system validation is defined as
“Confirmation by examination and provision of objective evidence that
software specifications conform to user needs and intended uses, and that
the particular requirements implemented through software can be consistently
fulfilled”
A computerized system includes: the computer hardware, computer software,
peripheral devices, personnel, and computer system documentation (including
computer hardware and software manuals, specifications for peripheral devices
and standard operating procedures).
The computerized system used to control
critical functions in food processing should be validated in its entirety. CSV
is a documented process for assuring that a computer system does what it is
designed to do. Validation of computer systems is not a onetime event it
periodic activity. CSV should be performed by person other than those
responsible for building system.
Purpose of CSV:
The purpose of the validation process is to provide a high degree of assurance that a specific process (or in this case computer system) will consistently produce a product (control information or data) which meets predetermined specifications and quality attributes.
Computer System Validation is more than a way to avoid profit loss and business risks. In certain instances, it can be life-saving.
Why CSV:
FDA regulations mandate the need to perform Computer System Validation and these
regulations have the impact of law. Having the evidence that computer systems
are correct for their purpose and operating properly represents a good business
practice.
CSV becomes important as the FDA requires all computerized systems
with GxP electronic records to be validated.
All computerized systems that have
an impact on product quality, patient safety and data integrity need to be
validated
- To ensure use of system is safe for quality of the product & health
of the patients
- Get confidence in Data produced by the system
- Compliance
with regulations
- Assure “Inspection Readiness”
- Avoid negative publicity
If
you failure to take corrective action in a timely manner can result in shutting
down manufacturing facilities, consent decrees & stiff financial penalties.
Benefits of CSV:
Legal compliance with the FDA: After completing Computer System Validation,
companies will be able to provide regulatory organs with all the needed
documentation
Reduces compliance risks. Having empirical evidence of the fact
that the system works as expected comes in handy during the inspections from
regulatory organs.
Discovers defects before a system build goes live. This way,
pharmaceutical companies can avoid image losses or fraud.
Provides companies
with continuous improvement. Validation is a necessity for companies that
constantly scale and add new features as it allows the development team to
prevent tech debt from piling up.
Maximizes system efficiency. If companies have
validated systems, a business manager increases its future value and the
efficiency of employers that use it. In the long run, CSV reduces both operating
and labor costs.
“Trust but Verify “ Ronald Reagan
Across the internet, there are millions
of resources are available which provide information about Everything.
If you found all content under one roof
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| Data Integrity App |
Our Data integrity app will helpful for
understanding what Data integrity & CSV really means & How 21 CFR Part
11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical
Industry.
- Basic Data Integrity Concepts
- ERES & Its Requirement
- CSV & Its best practices
- Mock Inspection and General Q&A
- Checklist for inspection
- Inspection Readiness
- Useful SOP’s
- Stay Regulatory Compliant.
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