Verification and Validation

From Wikipedia, the free encyclopedia

Verification and Validation (V&V) is the process of checking that a product, service, or system meets specifications and that it fulfils its intended purpose. These are critical components of a quality management system such as ISO 9000.

Contents

[edit] Terminology

Verification is a quality process that is used to evaluate whether or not a product, service, or system complies with a regulation, specification, or conditions imposed at the start of a development phase. Verification can be in development, scale-up, or production. This is often an internal process.

Validation is the process of establishing documented evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. This often involves acceptance and suitability with external customers.

It is sometimes said that validation ensures that ‘you built the right thing’ and verification ensures that ‘you built it right’. 'Building the right thing' refers back to the user's needs, while 'building it right' checks that the documented development process was followed. In some contexts, it is required to have written requirements for both as well as formal procedures or protocols for determining compliance.

[edit] Activities

Verification of machinery and equipment usually consists of Design Qualification - DQ [1], Installation Qualification - IQ [2], Operational Qualification - OQ [3] and Performance Qualification - PQ [4]. DQ is usually a vendor's job. However, DQ can also be performed by the user, by confirming through review and testing that the equipment meets the written acquisition specification. If the relevant document or manuals of machinery/equipment are provided by vendors, the later 3Q needs to be thoroughly performed by the users who work in an industrial regulatory environment. Otherwise, the process of IQ, OQ and PQ is the task of validation. The typical example of such a case could be the lost or absent of vendor's documentation for a legacy equipment or DIY assemblies (i.e. cars, computers etc.) and, therefore users should endeavour to acquire DQ document beforehand. Each template of DQ, IQ, OQ and PQ usually can be found on the internet respectively, whereas the DIY qualifications of machinery/equipment can be assisted either by the vendor's training course materials and tutorials, or by the published guidance books, such as step-by-step series if the acquisition of machinery/equipment is not bundled with on- site qualification services. This kind of the DIY approach is also applicable to the qualifications of software, computer operating systems and a manufacturing process. The most important and critical task as the last step of the activity is to generating and archiving machinery/equipment qualification reports for auditing purposes, if regulatory compliances are mandatory. At the same time, one should bear in mind to kindly share the original work with others, if the activity, especially validation of newly invented machinery/equipment, is worth of publishing.

Qualification of machinery/equipment is venue dependent and re-qualification needs to be conducted once the objects are relocated. The full scales of some equipment qualifications are even time dependent, and hence re-certification is necessary when a specified due time laps [5], [6]. Re-qualification of machinery/equipment should also be conducted when replacement of parts, or coupling with another device, or installing a new application software and restructuring of the computer which affects especially the pre-settings, such as on BIOS, registry, disk drive partition table, or an ini file etc, have been necessary. In such a situation, the specifications of the parts/devices/software and restructuring proposals should be appended to the qualification document whether the parts/devices/software are genuine or not. Torres and Hyman have discussed the suitability of non genuine parts for clinical use and provided guidelines for equipment users to select appropriate substitutes which are capable to avoid adverse effects [7]. In the case when genuine parts/devices/software are demanded by some of regulatory requirements, then re-qualification should not be conducted on the non genuine assemblies. In stead, the asset has to be recycled for non regulatory purposes.

When machinery/equipment qualification is conducted by a standard endorsed third party such as by an ISO standard accredited company for a particular division, the process is called certification [8], [9]. Currently, the coverage of ISO/IEC 15408 certification by an ISO/IEC 27001 accredited organization is limited, the scheme requires a fair amount of efforts to get popularized.

[edit] Industry references

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

Main article: Verification and Validation (software)
  • 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 [1]. Nash et al. have published a book which provides a comprehensive coverage on the various validation topics of pharmaceutical manufacturing processes [10]. Some companys are taking risk based approach to validating their GAMP system if ones understand the regulatory requirements very well while the most of others follows the conventional process [11], [12].
    • Medical devices The FDA (21 CFR) has validation and verification requirements for medical devices. . See guidance: [2] and ISO 13485
    • Manufacturing process and cleaning validation are compulsory and regulated by FDA [11], [13], [14], [15].
    • Food hygiene: example [3]
    • Clinical laboratory medicine: ISO 15198:2004 Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
Main article: Validation (drug manufacture)

[edit] Notes

  1. ^ Validation Online. DESIGN QUALIFICATION. Retrieved on 17 March 2008.
  2. ^ Validation Online. INSTALLATION QUALIFICATION. Retrieved on 17 March 2008.
  3. ^ Validation Online. OPERATIONAL QUALIFICATION. Retrieved on 17 March 2008.
  4. ^ Validation Online. PERFORMANCE QUALIFICATION. Retrieved on 17 March 2008.
  5. ^ Analytical & Precision Balance Co.. Welcome. Retrieved on 18 March 2008.
  6. ^ Scientech. External Calibration. Retrieved on 18 March 2008.
  7. ^ Torres, Rebecca E.; William A. Hyman (2007). Replacement Parts-Identical, Suitable, or Inappropriate?. Retrieved on 29 March 2008.
  8. ^ AppLabs. ISV, IHV Certification Programs. Retrieved on 26 March 2008.
  9. ^ AppLabs. AppLabs attains ISO27001:2005 accreditation. Retrieved on 26 March 2008.
  10. ^ Nash, Robert A. et al. (2003). Pharmaceutical Process Validation: An International Third Edition. Informa Healthcare, 860. ISBN 0824708385. 
  11. ^ a b De Caris, Sandro et al.. Risk-based equipment qualification: a user/supplier cooperative approach. Retrieved on 15 June 2008.
  12. ^ Ocampo, Arlene et al. (2007). "Current challenges for FDA-regulated bioanalytical laboratories for human (BA/BE) studies. Part I: defining the appropriate compliance standards - application of the principles of FDA GLP and FDA GMP to bioanalytical laboratories". The Quality Assurance Journal 11 (1): 3 - 15. John Wiley & Sons. doi:10.1002/qaj.399. 
  13. ^ Food and Drug Administration. GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES. Retrieved on 20 March 2008.
  14. ^ Nassani, Mowafak. Cleaning validation in the pharmaceutical industry. Retrieved on 20 March 2008.
  15. ^ Bharadia, Praful D.; Jignyasha A. Bhatt. A review of current implementation strategies for validation of cleaning processes in the pharmaceutical industry. Retrieved on 20 March 2008.
  16. ^ Masako, Tsujimoto. Verification of genetic recombination by hypha fusion of Pyricularia oryzas using transducing gene as marker. ( the Ministry of Agriculture, Forestry and Fisheries Natl. Agricultural Res. Center S ).. Retrieved on 20 March 2008.
  17. ^ Vollmer-Sanders, Carrie Lynn et al.. Implications of the Voluntary Michigan Agriculture Environmental Assurance Program (MAEAP) Verification on Livestock Operations, 2000-2004. Retrieved on 20 March 2008.
  18. ^ Haboudane, Driss et al. (2004). "Hyperspectral vegetation indices and novel algorithms for predicting green LAI of crop canopies: Modeling and validation in the context of precision agriculture". Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement 90 (3): 337 - 352. Elsevier. doi:10.1016/j.rse.2003.12.013. 
  19. ^ Thorp, Kelly et al.. USING CROSS-VALIDATION TO EVALUATE CERES-MAIZE YIELD SIMULATIONS WITHIN A DECISION SUPPORT SYSTEM FOR PRECISION AGRICULTURE. Retrieved on 20 March 2008.
  20. ^ Randolph, Susan et al.. Monitoring the Realization of the Right to Food: Adaptation and Validation of the U.S. Department of Agriculture Food Insecurity Module to Rural Senegal. Retrieved on 20 March 2008.

[edit] See also