Explicit Microsoft Excel Methods For Computerized System Validation

2021 ◽  
Vol 27 (4) ◽  
Author(s):  
Andrew Treller
Keyword(s):  
Explicit Methods ◽  
Microsoft Excel ◽  
System Validation ◽  
Regulatory Bodies ◽  
Computerized System

To combat CSV non-compliance, established here are cost and time effective explicit methods to verify and validate Microsoft Excel Workbooks designed to meet standards set by Australian regulatory bodies: The Therapeutic Goods Administration (TGA) and Pharmaceutical Inspection Co-operation Scheme (PIC/S).

scholarly journals Experimental Study on Strength Evaluation Applied for Teeth Extraction: An In Vivo Study

2013 ◽  
Vol 7 (1) ◽  
pp. 20-26 ◽  
Author(s):  
Marco Cicciù ◽  
Ennio Bramanti ◽  
Fabrizio Signorino ◽  
Alessandra Cicciù ◽  
Francesco Sortino
Keyword(s):  
Strain Measurement ◽  
In Vivo Study ◽  
Microsoft Excel ◽  
Premolar Extraction ◽  
Lower Jaw ◽  
System Data ◽  
Computerized System ◽  
Teeth Extraction

Purpose: The aim of this work was to analyse all the applied movements when extracting healthy upper and lower jaw premolars for orthodontic purposes. The authors wanted to demonstrate that the different bone densities of the mandible and maxilla are not a significant parameter when related to the extraction force applied. The buccal and palatal rocking movements, plus the twisting movements were also measured in this in-vivo study during premolar extraction for orthodontic purposes. Methods: The physical strains or forces transferred onto the teeth during extraction are the following three movements: gripping, twisting, and traction. A strain measurement gauge was attached onto an ordinary dentistry plier. The strain measurement gauge was constituted with an extensimetric washer with three 45º grids. The system operation was correlated to the variation of electrical resistance. Results: The variations of resistance (∆R) and all the different forces applied to the teeth (∆V) were recorded by a computerized system. Data results were processed through Microsoft Excel. The results underlined the stress distribution on the extracted teeth during gripping, twisting and flexion. Conclusions: The obtained data showed that the strength required to effect teeth extraction is not influenced by the quality of the bone but is instead influenced by the shape of the tooth’s root.

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.

scholarly journals A Good Practice–Compliant Clinical Trial Imaging Management System for Multicenter Clinical Trials: Development and Validation Study

10.2196/14310 ◽  
2019 ◽  
Vol 7 (3) ◽  
pp. e14310 ◽  
Author(s):  
Youngbin Shin ◽  
Kyung Won Kim ◽  
Amy Junghyun Lee ◽  
Yu Sub Sung ◽  
Suah Ahn ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Management System ◽  
Good Practice ◽  
Functional Requirements ◽  
System Validation ◽  
Multicenter Clinical Trials ◽  
Computerized System ◽  
Client System ◽  
Server System

Background With the rapid increase in utilization of imaging endpoints in multicenter clinical trials, the amount of data and workflow complexity have also increased. A Clinical Trial Imaging Management System (CTIMS) is required to comprehensively support imaging processes in clinical trials. The US Food and Drug Administration (FDA) issued a guidance protocol in 2018 for appropriate use of medical imaging in accordance with many regulations including the Good Clinical Practice (GCP) guidelines. Existing research on CTIMS, however, has mainly focused on functions and structures of systems rather than regulation and compliance. Objective We aimed to develop a comprehensive CTIMS to meet the current regulatory guidelines and various required functions. We also aimed to perform computerized system validation focusing on the regulatory compliance of our CTIMS. Methods Key regulatory requirements of CTIMS were extracted thorough review of many related regulations and guidelines including International Conference on Harmonization-GCP E6, FDA 21 Code of Federal Regulations parts 11 and 820, Good Automated Manufacturing Practice, and Clinical Data Interchange Standards Consortium. The system architecture was designed in accordance with these regulations by a multidisciplinary team including radiologists, engineers, clinical trial specialists, and regulatory medicine professionals. Computerized system validation of the developed CTIMS was performed internally and externally. Results Our CTIMS (AiCRO) was developed based on a two-layer design composed of the server system and the client system, which is efficient at meeting the regulatory and functional requirements. The server system manages system security, data archive, backup, and audit trail. The client system provides various functions including deidentification, image transfer, image viewer, image quality control, and electronic record. Computerized system validation was performed internally using a V-model and externally by a global quality assurance company to demonstrate that AiCRO meets all regulatory and functional requirements. Conclusions We developed a Good Practice–compliant CTIMS—AiCRO system—to manage large amounts of image data and complexity of imaging management processes in clinical trials. Our CTIMS adopts and adheres to all regulatory and functional requirements and has been thoroughly validated.

scholarly journals Sistem Informasi Persediaan Barang Menggunakan Framework Bootstrap dan Bahasa Pemrograman PHP MYSQL

2021 ◽  
Vol 9 (2) ◽  
pp. 50-57
Author(s):  
Muhamad Ari Nurjani ◽  
Iman Mulyadi ◽  
Ardi Taryanto
Keyword(s):  
Microsoft Excel ◽  
Computerized System

Online shop companies that are currently running only use Microsoft excel in recording, selling, purchasing for inventory. In making invoices and purchases still use only notes. With this system running, there are many errors that often occur, such as the loss of sales invoices, the loss of travel documents and which result in no evidence of transactions that have occurred. Therefore we need a computerized system that can help to make sales purchases more easily and can check stock items very easily and accurately. The design of this system starts from the warehouse first to record incoming goods then make a purchase invoice and here the warehouse confirms to the shop owner, if approved, the owner will ask the admin to make stock adjustments, after the stock is reduced, the admin will confirm to the Warehouse and the Warehouse will make a travel document to be continued to the consumer.

scholarly journals A retrospective cross-sectional study to determine chirality status of registered medicines in Tanzania

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Kissa W. Mwamwitwa ◽  
Raphael M. Kaibere ◽  
Adam M. Fimbo ◽  
Wilber Sabitii ◽  
Nyanda E. Ntinginya ◽  
...  
Keyword(s):  
Cross Sectional Study ◽  
Sectional Study ◽  
African Countries ◽  
Microsoft Excel ◽  
Cross Sectional ◽  
The Public ◽  
Registration Data ◽  
Lack Of Information ◽  
Regulatory Bodies ◽  
Stereogenic Center

Abstract Medicines with a stereogenic center (asymmetric carbon) are mainly present as racemates with a mixture of equal amounts of enantiomers. One enantiomer may be active while the other inactive, alternatively one may produce side-effects and even toxicity. However, there is lack of information on the chirality status (either racemates, single active enantiomer or achiral) of medicines circulated on the market particularly in African countries. We established the chirality status of registered medicines in Tanzania by conducting a retrospective cross-sectional study. Registration data for the past 15 years from 2003 to 2018 were extracted from TMDA-IMIS database to Microsoft excel for review and analysis. A total of 3,573 human medicines had valid registration. Out of which 2,150 (60%) were chiral and 1,423 (40%) achiral. Out of the chiral medicines, 1,591 (74%) and 559 (26%) were racemates and single active enantiomers, respectively. The proportion of racemates within chiral medicines was considerably higher than single enantiomer medicines. The use of racemates may cause harm to the public and may contribute to antimicrobial resistance due to potential existence of inactive and toxic enantiomers. In order to protect public health, regulatory bodies need to strengthen control of chiral medicines by conducting analysis of enantiomeric impurity.

scholarly journals Pengembangan Sistem Pengelolaan Pemasukan dan Pengeluaran Keuangan Berbasis Web

2020 ◽  
Vol 13 (1) ◽  
pp. 16-23
Author(s):  
Amirul Iqbal
Keyword(s):  
Information Technology ◽  
Data Processing ◽  
Efficient Method ◽  
Financial Management ◽  
Financial Data ◽  
Microsoft Excel ◽  
Business Operations ◽  
Expenditure Data ◽  
A Company ◽  
Computerized System

The advancement of information technology especially in computerized systems is snowballing. It is also backed by a range of demands from industry/ companies that want to abandon the conventional way of conducting business operations to the use of information technology. MÈMORE is a company engaged in the decoration and crafts industry. The company is now using a computerized system in the form of Microsoft Excel software to monitor the company's income and expense and the company often maintains a separate report in a special book. However, this causes problems for these businesses as there is no more efficient method for data processing or for handling the income and expense. In order to solve the problems of the company, a computerized system of financial management is required that will be tailored to the problems and needs of the owner of the business in order to support the company's growth with reliable, managed, and safe financial data. The system can also differentiate its use between the owner and the employee. It is useful for ensuring the confidentiality and protection of company revenue and expenditure data. 

scholarly journals Chirality Status Of Registered Medicines In Tanzania: A Retrospective Cross-Sectional Study

2020 ◽  
Author(s):  
Kissa Watson Mwamwitwa ◽  
Raphael M. Kaibere ◽  
Adam M. Fimbo ◽  
Wilber Sabitii ◽  
Nyanda E. Ntinginya ◽  
...  
Keyword(s):  
Cross Sectional Study ◽  
Reproductive Hormones ◽  
Sectional Study ◽  
African Countries ◽  
Microsoft Excel ◽  
Regulatory Requirement ◽  
Cross Sectional ◽  
The Public ◽  
Regulatory Bodies ◽  
Stereogenic Center

Abstract Background Medicines with a stereogenic center (asymmetric carbon) mainly presents as racemates with a mixture of equal amounts of enantiomers. One enantiomer may be active while the other inactive, alternatively one may produce side-effects and even toxicity. Worldwide there is no mandatory regulatory requirement to enforce the development of new chiral medicines as exclusively pure active single enantiomers. This has contributed to the existence of both single enantiomers and racemates on the market. Moreover, literature shows the tendency of regulatory approval of medicines towards the development of pure single enantiomers 60%, only 5–10% racemates and 30–35% as achiral. This status has not been established particularly in African countries including Tanzania. Therefore, we aimed to establish the chirality status of registered medicines in Tanzania. Methodology: A retrospective cross-sectional study was conducted by reviewing all human medicines registered in Tanzania for the past 15 years from 2003 to 2018. Data were extracted from TMDA-IMIS database to Microsoft excel for analysis. Medicines were assessed to determine if they were chiral (racemates or single enantiomers) or achiral. Results A total of 3,573 human medicines had valid registration. Most of these medicines 2,150 (60%) are chiral and 1,423 (40%) are achiral. Out of the chiral medicines, 1,591 (74%) and 559 (26%) were racemates and single enantiomers, respectively. The percentage of chiral medicines for anti-infective (35%) was significantly higher (p < 0.0001) than other pharmacological groups. A high proportion of chiral medicines within pharmacological groups were observed in systemic hormonal preparations (excluding reproductive hormones and insulin) 97.3% (36/37) and anti-infectives 80% (753/941). Conclusion The study revealed the existence of both chiral and achiral registered human medicines with chiral medicines predominating. The proportion of racemates within chiral medicines was significantly higher than that of single enantiomer medicines. The use of these racemates may cause harm to the public and may also contribute to antimicrobial resistance due to the potential existence of inactive and toxic enantiomers. In order to protect public health, regulatory bodies need to strengthen the control of chiral medicines by including an analysis of enantiomeric impurity.

Desain Sistem Informasi Pengolahan Data Stok Air Minum Dalam Kemasan Pada Pt.Amia Batusangkar

2018 ◽  
Vol 4 (2) ◽  
pp. 182
Author(s):  
Firdaus Daus
Keyword(s):  
Decision Making ◽  
Decision Making Process ◽  
Microsoft Excel ◽  
Inventory Costs ◽  
Transaction Process ◽  
Total Inventory ◽  
Conducting Research ◽  
First In First Out ◽  
Computerized System ◽  
Physical Calculation

<span id="result_box" lang="en"><span>After conducting research at PT.</span> <span>Amanah Insanillahia Batusangkar found problems regarding the transaction process where the recording is still using Microsoft Excel on a standard basis.</span> <span>This has resulted in reports that are not accurate and precise.</span> <span>Inventory of goods using First In First Out (FIFO) can be controlled more and can know the total inventory costs that exist at any time without having to do the first physical calculation.</span> <span>The results of this study are a design information system inventory data on bottled drinking water stock at PT.</span> <span>AMIA Batusangkar uses the First In First Out (FIFO) method.</span> <span>By utilizing a computerized system is expected to help the decision-making process and by utilizing the PHP programming language as a software and MySQL database, this application can help less effective and efficient ways and can facilitate the making of results reports and decision making.</span></span>

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