Abstract
Computer Systems Validation is a method used to ensure information is generated by a computer-based system that satisfies a set of specified requirements. Compliance with computerized systems is becoming increasingly relevant in the pharmaceutical industry as computer system validations have many benefits, such as enhancing quality control, reducing other validation costs and time, improving compliance with GMP 21 CFR Part 11 Regulation which affects the quality, health, identification or effectiveness of products subject to the GMP Regulations. Both the European Medicines Agency of Europe along with the Food & Drug Administration of the USA has developed CSV practice guidelines. An overview of relevant documents which fulfil the computer system validation along with its best practices implemented is presented below. Official requirements and standards of the USA, Europe, and Switzerland are taken as the main focus. The taken basic GMP guidelines' like Gamp, AVP and PDA implies the same principles and theories. They explain majorly about what to do view point of validation, whereas GAMP describes how to do validation. We strive to define the computer device validation needs of equipment conducted from a pharmaceutical industry perspective. The categorization of a computer system into various frameworks or categories gives the flexible approach for the validation of complex as well as simple computerized systems. The present review article discusses the implementation and various good practices of the pharmaceutical industry to maintain computer system validation. Implementing various good computer system validation activities reduces the re-work and always maintains the quality standards as per the user requirements; as a result of which the future trends will notice merging of various new implemented terminology and techniques as a common practice in mixed sectors.
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References
Administration 2014. Glossary of Computer System Software Development Terminology. pages 1–64.
Astrix 2018. Best Practices for Computer System Validation. Accessed on 17 June 2018.
Beck-Sickinger, A., Imanidis, G., Marrer, S. 1998. Quality assurance in computer validation systems postgraduate seminar on quality assurance in the pharmaceutical industry. Pharmaceutica Acta Helvetiae, 72(6):315. ISSN: 0031-6865.
Bendale, A., Patel, N., Damahe, D. P., Narkhede, S. B., Jadhav, A. G., Vidyasagar, G. 2011. Computer Software Validation in Pharmaceuticals. Asian J Pharm Sci Clin Res [Internet], 1(2):27–39.
Branning, R. C. 1988. Computer Systems Validation. Good Laboratory Practices, 13:66–74. ISBN13: 9780841214804.
Budihandojo, R., Bergeson, D. J., D’Eramo, P., Huber, L., Lopez, O., Perez, A., et al. 2001. The future state of computer validation, part I. Pharmaceutical Technology, 25(7):86–93.
CFR 2020. Code of federal regulations. Page: 76-97, Accessed on 01 April 2020.
Datta, N., Pal, M., Roy, U., Mitra, R., Pradhan, A. 2014. Computer Validation and Ethical Security Measures for Pharmaceutical Data Processing. Infection, 13:15.
De Claire, T. 2003. Computer System Validation Controlling the manufacturing process. Pharm Process Validation An International third Edition Revised Expand, pages 525–601.
Desain, C. V., Sutton, C. V. 2020. General Principles of Software Validation. Validation for Medical Device and Diagnostic Manufacturers, pages 285–312.
Dhatchanamoorthi, N. 2020. An Overview on Challenges and Importance of Computer system Validation in Pharmaceutical Industry. Res J Pharm Tech [Internet], 13(11):5591–5594.
O’Donnell 2020. FDA Software Validation: Guide, Methods, Tools and Template. The Datacor Blog. Accessed on 28 April 2020.
Europe, U. 2019. General European OMCL Network (GEON) Quality Management Document. pages 1–10.
FDA US Guidance for the industry 2000. Analytical procedures and methods validation: chemistry, manufacturing, and controls and documentation. Pages: 223-243.
Friedli, D., Kappeler, W. 1998. Validation of computer systems: practical testing of a standard LIMS. Pharm Acta Helv, 72(6):343–351.
GMPSOP 2021a. Computer Validation Guideline. page 15.
GMPSOP 2021b. Guideline for the Development of a Computer Validation Project Plan. page 130.
GMPSOP 2021c. Impact Assessment for Computerised Systems. page 19.
Hardik, V., Patela, E. N. 2011. A review on computer aided instrument validation. J Chem Pharm Res, pages 134–143. Corpus ID: 7454651.
Hoffmann, A., Kähny-Simonius, J., Plattner, M., Vanja Schmidli-Vckovski, Kronseder, C. 1998. Computer system validation: An overview of official requirements and standards. Pharmaceutica Acta Helvetiae, 72(6):317–325. ISSN: 0031-6865.
Huber, L. 2009. Huber L. Analytical Instrument Qualification and System Validation. Regulations and Quality Standards, pages 1–67.
Kennedy, A. 2020. Computer validation. 3. Accessed on 03 May 2020.
Kummer, R. V. 2010. Neurowoche 2010: A Highlight of Neuromedicine in Germany. Clinical Neuroradiology, 20:151–152. ISSN: 1869-1439, 1615-6706.
Nazario, A. C. 2018. Computer System Validation CSV in Data Integrity Implementation Strategies for Pharmaceutical Industry. pages 1–9.
Nollau, B. J. 2009. Computer Systems Quality and Compliance vs. Software Validation. J GXP compliance, 13(1):36–38.
Nursalam 2013. Metode penelitian. GAMP5 A Risk-Based Approach to Compliant GxP Computerized Systems. J Chem Inf Model, 53(9):1689–1699.
O’Donnell 2020. FDA Software Validation: Guide, Methods, Tools and Template. The Datacor Blog. Accessed on 28 April 2020.
Pic/S 2007. Good Practices for Computerised “ Gxp ” Environments. pages 1–54.
Schönberger, M., Vasiljeva, T. 2018. Towards Computer System Validation: An overview and Evaluation of Existing Procedures. Journal of Innovation Management in Small and Medium Enterprises, 2018:1–15.
Schumacher, W. 2003. Industry Guidelines for Computerized Systems Validation. GAMPPDA Technical Reports, pages 16–23.
Singh, A., Singour, P., Singh, P. 2018. Computer system validation in the perspective of the pharmaceutical industry. Journal of Drug Delivery and Therapeutics, 8(6-s):359–365. ISSN: 2250-1177.
Stain, R. T., Paton, S. M. 2006. The computer system risk management and validation life cycle. ISBN: 1-932828-09-5.
Tramontana, D. 2020. The Secret Code of Software Validation. In 5 Easy Steps. QAD CEBOS. Accessed on 2 May 2020.
Wakabayashi, Y., Matsui, H., Ikai, K., Hayashi, M., Wakabayashi, H., Yamamoto, K. 2017. Developing a Practical Method for Validation of Computerized Systems Integrated with Smart and/or Wearable Devices for Regulatory Compliance of Clinical Trials. Therapeutic Innovation and Regulatory Science, 51:118–124. ISSN: 2168-4790, 2168-4804.
Wazade, M. B., Walde, S. R., Ittadwr, A. M. 2012. An Overview of Pharmaceutical Process Validation and Process Control Variables of Tablets Manufacturing Processes in Industry. Int J Pharmaceutical Sci Res, 3(09):3007–3029.
Williams, M. H. 1993. Good Computer Validation Practice is Good Business Practice. Drug Information Journal, 27(2):333–345. ISSN: 0092-8615.
Woodrum, T. D. 1998. Computer System Validation: Value Added Activities Meeting Regulatory Imperatives. Drug Information Journal, 32(4):941–945. ISSN: 0092-8615, 2164-9200.
Yogesh, P., Mohini, B., Phad, R., Ismail, S., Shivam, L. 2015. Computer System Validation: a Review. World Journal of Pharmaceutical Research, 4(9):444–454. ISSN: 2277-7105.
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