Verified - Industry References

Industry References

These terms generally apply broadly across industries and institutions. In addition, they may have very specific meanings and requirements for specific products, regulations, and industries. Some examples:

• Software and computer systems
• Food and Drug
  • Pharmaceuticals The design, production, and distribution of drugs are highly regulated. This includes software systems. For example in the USA, the Food and Drug Administration have regulations in Part 21 of the Code of Federal Regulations. Nash et al. have published a book which provides a comprehensive coverage on the various validation topics of pharmaceutical manufacturing processes. Some companies are taking a risk-based approach to validating their GAMP system if one understands the regulatory requirements very well while the most of others follows the conventional process It is a part of GxP management. The aspects of validation and verification are even more intense and emphasized if an OOS occurs. Very often under this circumstance, a multiplicated sample analysis is required for conducting the OOS investigation in a testing laboratory.
  • Medical devices The FDA (21 CFR) has validation and verification requirements for medical devices. See guidance: and ISO 13485
  • Manufacturing process and cleaning validation are compulsory and regulated by the U.S. Food and Drug Administration
  • Food hygiene: example
  • Clinical laboratory medicine: ISO 15198:2004 Clinical laboratory medicine—In vitro diagnostic medical devices—Validation of user quality control procedures by the manufacturer

• Health care: example

• Greenhouse gas: ISO 14064 ANSI/ISO: Greenhouse gases — Requirements for greenhouse gas validation and verification bodies for use in accreditation or other forms of recognition
• Traffic and transport
  • Road safety audit
  • Periodic motor vehicle inspection
  • Aircraft noise: example
  • Aircraft:
• Model:
• (Ni-Cd) cells: example
• ICT Industry: example
• Civil engineering
  • Buildings –
  • Roads –
  • Bridges –
• Economics
• Accounting
• Agriculture – applications vary from verifying agricultural methodology and production processes to validating agricultural modeling
• Real estate appraisal – audit reporting and authentication