scholarly journals Towards Computer System Validation: An overview and Evaluation of Existing Procedures

2018 ◽  
Vol 2018 ◽  
pp. 1-15 ◽  
Author(s):  
Marius Schönberger ◽  
Tatjana Vasiljeva
Keyword(s):  
Computer System ◽  
System Validation

A Practical Approach to Computerized System Validation

2009 ◽  
pp. 456-469
Author(s):  
Kashif Hussain
Keyword(s):  
Computer System ◽  
Quality Standards ◽  
Practical Approach ◽  
Technical Aspects ◽  
Organization Commitment ◽  
System Validation ◽  
Related Quality ◽  
Computerized System

This chapter provides a practical approach to computerized system validation (CSV) for the pharmaceutical organizations for the users dealing with the validation. Validation package including plan, responsibilities, and documentation needed and created during the validation are also discussed. Any computer system can be validated utilizing the techniques described here. These activities address the organization commitment to implement the underlying system in order to improve, ensure and maintain the quality standards. The CSV is described as a reference and an orientation guide to understand the related quality processes. The activities presented here should be useful for initiating and conducting the principal tasks of validation. This chapter reflects a quick guide and addresses one of the “non-technical” aspects of CSV methodology. A clear approach is presented that defines the CSV activities and provides an efficient means of validation to new and existing systems, applications, and environments within the organization.

Computer system validation: An overview of official requirements and standards

1998 ◽  
Vol 72 (6) ◽  
pp. 317-325 ◽  
Author(s):  
Andreas Hoffmann ◽  
Jacqueline Kähny-Simonius ◽  
Marcel Plattner ◽  
Vanja Schmidli-Vckovski ◽  
Christian Kronseder
Keyword(s):  
Computer System ◽  
System Validation

scholarly journals CORRIGENDUM: Computer system validation

2021 ◽  
Vol 26 (1) ◽  
pp. 1-1
Author(s):  
Tomaž Sallubier ◽  
Borut Rusjan
Keyword(s):  
Quality Management ◽  
System Design ◽  
Computer System ◽  
Management System ◽  
Quality Management System ◽  
System Validation ◽  
Process Implementation

The authors regret that in „Computer system validation: Example of quality management system design and process implementation“ the following co-author was mistakenly missed from the authorship: Tomaž Sallubier, TS4U d.o.o, Kamnik, Slovenia.

Implementation of Good Computer System Validation Practices In Pharmaceutical Industry- A Review

2021 ◽  
Vol 12 (3) ◽  
pp. 1729-1739
Author(s):  
Chinta Sharvani ◽  
Vikas Jain ◽  
Hemanth Kumar ◽  
Gangadharappa H V
Keyword(s):  
Pharmaceutical Industry ◽  
Computer System ◽  
European Medicines Agency ◽  
User Requirements ◽  
System Validation ◽  
Computer Device ◽  
Quality Health ◽  
Device Validation ◽  
The Usa ◽  
Computer Based

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.

scholarly journals Computer system validation

2020 ◽  
Vol 25 (2) ◽  
pp. 1-23
Author(s):  
Borut Rusjan
Keyword(s):  
Pharmaceutical Company ◽  
Computer System ◽  
Quality Management System ◽  
Single Case ◽  
Computer Systems ◽  
Practical Case ◽  
Validation Process ◽  
Legal Requirements ◽  
System Validation ◽  
Regulated Industries

The purpose of this paper is to present a Quality Management System (QMS) for computer systems validation and to identify and demonstrate the validation process on a practical case of a pharmaceutical company. Based on the European and the US legal requirements, we define QMS for computer system validation elements. Validation process example based on the use of a general V-model provides a thorough understanding of the actual validation implementation in practice. Computer system validation in a concrete organization can be implemented, based on general and specific standard operating procedures which form the QMS. Planning, Specifying, Development/Building, Verification and Report validation activities are presented through process diagrams based on a practical Supervisory Control and Data Acquisition (SCADA) manufacturing computer-aided system validation example. Empirical part employed two research strategies: a single case study and action research. Presented computer system validation QMS and process can provide a guideline for all companies where computer systems are important. Although the presented QMS and process for the computer system validation are related to a specific pharmaceutical company case and its legal requirements, the experience from this highly regulated industry can be appropriately used in other less regulated industries. For verification of the proposed model, they need to be further tested within the pharmaceutical and other less regulated industries.

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