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  • Software Validation

    9 Essential IT SOP’s When Implementing a Regulated Computer System

    August 18, 2014

    Often when organizations are looking to implement regulated electronic systems for the first time, they overlook the need for IT Standard Operating Procedures (SOP’s). Organizations who fail to create the appropriate IT SOP’s in time, can become victim to costly delays later on in their implementation projects. Identifying which SOPs are required at the beginning […]

    3 SHARES
  • General Validation

    A Risk-Based Approach to Validation – Overview

    August 8, 2014

    FDA classically has defined the requirements for validation under 21 CFR 820 and 210/211 regulations as a comprehensive testing process where all systems are given thorough examination and tested under equal weight, complete with an exhaustive evaluation process. Recent guidance and initiatives by FDA (Process Validation: General Principles and Practices) and ICH (Q11: DEVELOPMENT AND […]

    5 SHARES
  • Software Validation SP

    Validating SharePoint: 6 Steps to Take Before You Start

    August 5, 2014

    Orginally posted on the Montrium blog If you are thinking of using SharePoint for electronic records management, you may also find yourself thinking about how you are going to be validating the system. SharePoint validation is fairly straight-forward, but it will require some preparation on your part. Here is a list of steps to take […]

    4 SHARES
  • Software Validation

    Risk Based Approach to Reduce Costs when Implementing Regulated Software

    July 13, 2014

    For companies doing business in regulated environments, the benefits of implementing software systems are abundant. Improved product safety, higher quality, enhanced efficiency, and increased probability of maintaining regulatory compliance are just a sample of the numerous benefits computerized systems can provide. Why, then, do so many companies resist implementing software systems? The primary culprit is […]

    2 SHARES
  • Software Validation

    Disaster Recovery & Business Continuity – Did You Validate?

    June 27, 2014

    Today’s business world shudders at the word. With the current random occurrences of hurricanes, super storms, earthquakes, blizzards, fires, flooding and sustained power outages, it is a wonder how companies can recover to survive all of the natural or modern threats to their daily business operations and collection of business data. Today’s business world is […]

    19 SHARES
  • Software Validation

    Validating Excel Spreadsheets and Automated Forms

    June 9, 2014

    Since the release of 21 CFR Part 11 in 1997, the validation and verification of electronic records has been at the forefront of the Information Technology (IT), Quality Assurance (QA) and Regulatory departments of the medical device and pharmaceutical industries. From simple record control through electronic signature approval routing and automated records processing, the validation […]

    2 SHARES
  • Newsletters

    21 CFR Part 11 Book

    June 5, 2014

    An Easy to Understand Guide to 21 CFR Part 11 By Orlando Lopez This book is for anyone working in a regulated environment that wants to learn more about 21 CFR Part 11. Written in a clear concise manner, we can guarantee that this book will bring you up to speed very quickly. Available in […]

    0 SHARES
  • Software Validation

    How to Deploy a Software Application in a GxP Environment – Planning & Design

    June 2, 2014

    As the regulated sector becomes more and more computerised it is paramount that you understand how to deploy computerized systems in a compliant manner adhering to FDA regulations and best practices. It takes careful planning between the client (the regulated company) and the vendor (the software company) to ensure a smooth transition from planning to […]

    4 SHARES
  • Newsletters

    Software Validation Book

    May 29, 2014

    An Easy to Understand Guide to Software Validation By Don Hurd This book is for anyone working in a regulated environment that wants to learn more about software validation. Written in a clear concise manner, we can guarantee that this wonderful book will bring you up to speed very quickly. Available in Print & PDF […]

    5 SHARES
  • Software Validation

    21 CFR Part 11 For Dummies Part 2 – Sec. 11.2 Implementation

    May 25, 2014

    This week we will be breaking down Subpart A – General Provisions, Sec. 11.2 Implementation of the Part 11 regulations and explaining in simple terms what each aspect of the regulations mean to you. If you missed Part 1 of this series click here to read about Sec 11.1 Scope. The actual text of the […]

    4 SHARES
  • Advertisement

    AskaboutValidation Keeps Getting Better. Check Out Our New Design!

    May 11, 2014

    Hi there, If you’re a regular visitor to askaboutvalidation.com you may have noticed that things are changing for the better in terms of our design. Over the last number of months, we have slowly phased in our new design based on customer feedback. Overall, we decided to make askaboutvalidation.com a site that is solely about […]

    4 SHARES
  • Advertisement

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    May 7, 2014

    Advertise With US Reach 30,000 Life Science Decision Makers & Professionals Every Month! Advertise with us for the following reasons: In business since 2006 Huge real-world presence in thousands of stores through our print and ebooks Advertising options to suit everyone Join the AskaboutValidation Business Development Portal website today at http://www.askaboutvalidation.com/forum/register.php We have members & visitors from […]

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  • Books

    Write For Us

    Showcase your Expertise to the World! AskAboutValidation strives to be at the forefront of new ideas, emerging challenges, and cutting-edge methodologies in the world of validation and compliance. We are always looking to partner with writers to bring these messages to the life science community. If you’ve got an idea for an article or a […]

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  • Software Validation

    21 CFR Part 11 For Dummies Part 1 – Sec. 11.1 Scope

    May 2, 2014

    It’s widely accepted that the Part 11 regulations have caused major headaches down through the years from systems that simply don’t have the necessary technology to fulfil the regulations down to people’s interpretations of them. Since starting this forum back in 2007 it was clear to see from the regular posts that many people globally […]

    6 SHARES
  • Analytical Validation test-tubes

    The Application of FMEA to Laboratory Instrument Qualification Risk Management – Part 2

    April 25, 2014

    Read Part 1 First To read Part 1 of this great article click here. Failure Mode and Effects Analysis (FEMA) Failure Mode and Effects Analysis (FEMA) is an inductive reasoning risk assessment tool that considers risk as a product of the following components: Severity of the consequences of a potential failure (S) Likelihood of a […]

    3 SHARES

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