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 in the perspective of the pharmaceutical industry

2018 ◽  
Vol 8 (6-s) ◽  
pp. 359-365
Author(s):  
Asheesh Singh ◽  
Pradeep Singour ◽  
Parul Singh
Keyword(s):  
Pharmaceutical Industry ◽  
Computer System ◽  
Quality Standards ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Products ◽  
Technology System ◽  
System Validation ◽  
Life Saving ◽  
Computer Based ◽  
Pharmaceutical Industries

Computer Systems Validation (CSV) is a process used to ensure (and document) that a computer based systems will produce information or data that meet a set of defined requirements. If a system meets these requirements, it can be assumed that it is consistently performing in the way it was intended. Quality is an imperative for customers whenever they consider a product or service. It is also important as it relates to life-saving products such as pharmaceuticals. In this regard, the Food and Drug Administration introduced good manufacturing practice (GMP) to maintain and improve the quality of pharmaceutical products. GMP ensures that products are consistently produced and controlled according to the quality standards appropriate to the intended use and as required by the marketing authorization. One of the major GMP requirements is that all of the critical manufacturing equipment, utilities, and facilities in the pharmaceutical industries must be properly qualified and validated prior to production. Currently, this practice forms the core of the regulations that are strictly followed by pharmaceutical companies worldwide.  A validation assessment program is a necessity in the pharma industry to ensure adherence to pharmaceutical cGMP guidelines, and to help companies maintain consistent quality. The same principles are applied in computer system validation to a computer system or an information technology system. It’s essential to maintain quality standards in pharma since non-conformance can have far-reaching consequences. Computer system validation checks the effectiveness and the efficiency with which the system is meeting the purpose for which it was designed. This study aims to identify needs of computer system validation of instrument/equipment practiced in the perspective of pharmaceutical industry. Keywords: Computer system validation, Validation, Qualification, GAMP

Pattern-Recognition: A Comparison of the Performance of Clinicians and Non-Clinicians - with a Note on the Performance of a Computer-Based System

1972 ◽  
Vol 11 (01) ◽  
pp. 32-37 ◽  
Author(s):  
F. T. DE DOMBAL ◽  
J. C. HORROCKS ◽  
J. R. STANILAND ◽  
P. J. GUILLOU
Keyword(s):  
Pattern Recognition ◽  
Computer System ◽  
Computer Aided Diagnosis ◽  
Clinical Interview ◽  
Computer Performance ◽  
Pattern Size ◽  
Computer Aided ◽  
Computer Based ◽  
Aided Diagnosis ◽  
Better Than

This paper describes a series of 10,500 attempts at »pattern-recognition« by two groups of humans and a computer based system. There was little difference between the performances of 11 clinicians and 11 other persons of comparable intellectual capability. Both groups’ performances were related to the pattern-size, the accuracy diminishing rapidly as the patterns grew larger. By contrast the computer system increased its accuracy as the patterns increased in size.It is suggested (a) that clinicians are very little better than others at pattem-recognition, (b) that the clinician is incapable of analysing on a probabilistic basis the data he collects during a traditional clinical interview and examination and (c) that the study emphasises once again a major difference between human and computer performance. The implications as - regards human- and computer-aided diagnosis are discussed.

Perangkat Sumber Daya Manusia (Brainware)

2020 ◽  
Author(s):  
Nadila Putri Ayu
Keyword(s):  
Data Processing ◽  
Computer System ◽  
Human Resource ◽  
Computer Aided ◽  
Computer Device ◽  
Systems Analysts

AbstrakPerangkat sumber daya manusia menjadi bagian terpenting dalam menjalankan atau mengoperasikan sebuah perangkat komputer. Manusia merupakan suatu elemen dari sistem komputer yang merancang bagaimana suatu mesin dapat bekerja sesuai dengan hasil yang diinginkan. Istilah yang digunakan untuk manusia yang berhubungan dengan komputer adalah Brainware. Brainware adalah semua personil atau tenaga kerja di bidang komputer, yakni yang terlibat dalam kegiatan pembentukan sistem komputerisasi maupun yang menangani dan mengawasi langsung bagian pengolahan data berbantuan komputer. Brainware terdiri dari Programer, Sistem Analis, Administrator, Teknisi Hardware, Teknisi Jaringan dan Web Master.Kata Kunci : Perangkat Sumber Daya Manusia AbstractHuman resource devices become the most important part in running or operating a computer device. Humans are an element of a computer system that designs how a machine can work in accordance with the desired results. The term used for humans related to computers is Brainware. Brainware is all personnel or workers in the computer field, that is, those involved in the formation of computerized systems as well as those who handle and directly supervise computer-aided data processing. Brainware consists of Programmers, Systems Analysts, Administrators, Hardware Technicians, Network Technicians and Web Masters.Keywords: Human resource device

Perangkat sumber daya manusia

2020 ◽  
Author(s):  
Fahriza Irfansyah
Keyword(s):  
Data Processing ◽  
Computer System ◽  
Human Resource ◽  
Computer Aided ◽  
Computer Device ◽  
Systems Analysts

Perangkat sumber daya manusia menjadi bagian terpenting dalam menjalankan atau mengoperasikan sebuah perangkat komputer. Manusia merupakan suatu elemen dari sistem komputer yang merancang bagaimana suatu mesin dapat bekerja sesuai dengan hasil yang diinginkan. Istilah yang digunakan untuk manusia yang berhubungan dengan komputer adalah Brainware. Brainware adalah semua personil atau tenaga kerja di bidang komputer, yakni yang terlibat dalam kegiatan pembentukan sistem komputerisasi maupun yang menangani dan mengawasi langsung bagian pengolahan data berbantuan komputer. Brainware terdiri dari Programer, Sistem Analis, Administrator, Teknisi Hardware, Teknisi Jaringan dan Web Master. Human resource devices become the most important part in running or operating a computer device. Humans are an element of a computer system that designs how a machine can work in accordance with the desired results. The term used for humans related to computers is Brainware. Brainware is all personnel or workers in the computer field, that is, those involved in the formation of computerized systems as well as those who handle and directly supervise computer-aided data processing. Brainware consists of Programmers, Systems Analysts, Administrators, Hardware Technicians, Network Technicians and Web Masters.

scholarly journals INSIGHTS ON TEACHING CHESS TO UNDERGRADUATE UNIVERSITY STUDENTS

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
William Bart
Keyword(s):  
University Students ◽  
Undergraduate Students ◽  
Critical Evaluation ◽  
Thinking Skills ◽  
First Year ◽  
State University ◽  
Correct Usage ◽  
Undergraduate University Students ◽  
The Usa ◽  
Computer Based

The purpose of this study was to explore how undergraduate university students react to chess instruction. Certain patterns emerged from 10 offerings of a Freshman Seminar entitled “Beginners’ Chess and 21st Century Thinking Skills”. The course enrolled only first-year and second-year undergraduate students at a large public state university in the USA. The students tended to have little or no knowledge of chess prior to the course. The course made extensive use of chess-related websites available on the Internet such as chess.com, lichess.org, and chessgames.com. The instruction involved the projection of a chess-related website projected onto a large classroom screen with the use of an instructor’s computer connected to a projector that projected the computer-based image onto the screen. The course had 10-20 students in each annual offering of the course that lasted 15 weeks. The student evaluations of the course were very positive, indicating that the students enjoyed the course very much. The course involved instruction in chess on topics such as tactics and basic checkmates along with instruction on the cognitive psychological foundations of chess on topics such as problem solving and critical thinking. The primary task in the course was that each student had to prepare a critical evaluation of two of their own chess games that included correct usage of proper algebraic notation for the chess moves. The chess activity that the students enjoyed the most was group competition.

Access to innovative cancer medicines in gastrointestinal oncology: 2010 through 2020.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 469-469
Author(s):  
David Edward O Reilly ◽  
Ronan Andrew McLaughlin ◽  
Cian Ronayne ◽  
Anne-Marie DeFrein ◽  
Bojan Macanovic ◽  
...  
Keyword(s):  
Overall Survival ◽  
Median Time ◽  
Progression Free Survival ◽  
Clinical Excellence ◽  
Control Programme ◽  
List Price ◽  
European Medicines Agency ◽  
Patient Access ◽  
The Usa ◽  
The Uk

469 Background: There are significant disparities in patient access to innovative cancer medicines internationally. We sought to describe global drug licensing developments in gastrointestinal (GI) oncology from 2010 – 2020. We compared US, European, UK and Irish patient access to these drugs, their cost and associated efficacy. Methods: Data was collected from public sources online including the FDA, European Medicines Agency (EMA), the UK National Institute of Clinical Excellence (NICE) and the Irish National Cancer Control Programme (NCCP). Anti-cancer compounds approved for GI malignancies between January 1, 2010 and September 1, 2020 were recorded. Approval publications and updated survival analysis outcomes were included to assess for demonstrable overall survival (OS) and/or progression free survival (PFS) benefit. Results: There were 26 regimens approved by the FDA for GI malignancies between 2010 and 2020. Slightly over half (n=15, 57.7%) of these regimens were approved by the EMA. The median time from FDA to EMA approval was 3 months (mo) +/- 5 mo. Only a small minority of these regimens were funded for patients in the UK (including the Cancer Drugs Fund, 9 regimens, 31%) or Ireland (IRL) (7 regimens, 27%). The median time from EMA approval to patient access was short in both of these countries (3.5 mo (UK) and 0.5 m (IRL)). However, the range in these countries was large (2 - 73 mo (UK) & 0-24 mo (IRL)). More than half of regimens (15, 57.7%) demonstrated an OS benefit. Of the remaining 11 regimens, a further 6 drugs (23%) demonstrated a PFS benefit. The median OS benefit (if present) was 2.3 mo +/- 3 mo. The median price of these regimens in the USA (list price) was $13,758 per month +/- $5,152. Regimens which demonstrated an OS benefit were not more expensive than those that did not (median $13,065 versus $13,758 respectively, p < 0.05). For regimens with an OS benefit, there was no statistically significant correlation between the length of OS benefit and drug cost (Pearson’s correlation = 0.32, p = 0.07). Conclusions: Less than one third of patients in the UK and Ireland have access to medicines approved by the FDA for GI malignancies between 2010 – 2020. Overall survival benefits are often modest, or absent. The cost of regimens in the USA commonly exceeds $100,000/year irrespective of OS benefit. Our work highlights the necessity to develop a value based-pricing system in GI oncology.

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.

The Work of Preparing Canadian Nurses for A Licensure Exam Originating from the USA: A Nurse Educator’s Journey into the Institutional Organization of the NCLEX-RN

2019 ◽  
Vol 16 (1) ◽  
Author(s):  
Kristin Petrovic ◽  
Emily Doyle ◽  
Annette Lane ◽  
Lynn Corcoran
Keyword(s):  
Nursing Education ◽  
Nursing Students ◽  
Registered Nurses ◽  
The United States ◽  
National Council ◽  
National Council Licensure Examination ◽  
Institutional Organization ◽  
The Usa ◽  
Computer Based ◽  
Exam Result

AbstractThe licensing exam for registered nurses in Canada has recently been changed from a Canadian developed, owned and delivered exam to the National Council Licensure Examination for Registered Nurses (NCLEX-RN) which originates from the United States. Rationale for this exam change focused on transitioning to a computer-based exam that has increased writing dates, with increased security, validated psychometrics, increased exam result delivery, and an anticipated decrease in expense to students. Concerns have arisen around the acceptance, implementation and delivery of this exam to Canadian nursing students that reflects the broad Canadian landscape of education and nursing practice. The experience of a Canadian nurse educator in working to facilitate students’ transition to this exam is addressed using an institutional ethnographic lens. Finally, we come to conclusions about the importance of countries utilizing licensing exams that reflect their nursing education and practice

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