History of Computer System Validation in Pharmaceutical Industry
History of Computer System Validation:
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).
FDA issued final part 11 regulations In March of 1997, became effective in August 1997 & Revised in August 2003.
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.
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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
CSV Need to:
- 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.
List of Guideline
Following is the list of some Validation Guiding Specification commonly used in validating Laboratory Automation System:
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, 21 CFR 11, 21 CFR 820.
- GAMP (Good Automated Manufacturing Process).
- PDA Technical Report 18, Validation of Computerized Systems.
- ASTM E2066–00 Standard Guide for Validation of Laboratory Information Management Systems.
- NRC Regulatory Guide 1.170 in compliance to 10 CFR 50.
- 1012–2004 IEEE Standard for Software Verification and Validation.
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