Online Safety Community

It is important for organizations to validate their own Excel Spreadsheet Application


It is important for organizations to validate their own Excel Spreadsheet Application.jpghttps://globalcompliancepaneltraining.files.wordpress.com/2018/02/it-is-important-for-organizations-to-validate-their-own-excel-spreadsheet-application.jpg?w=150 150w, https://globalcompliancepaneltraining.files.wordpress.com/2018/02/i... 300w, https://globalcompliancepaneltraining.files.wordpress.com/2018/02/i... 670w" sizes="(max-width: 422px) 100vw, 422px" width="422" height="211" />

Organizations that validate their Excel spreadsheet applications stay compliant with FDA requirements,avoid 483’s and save two-thirds of the cost and time on validation.

A critical requirement from the FDA is validation of electronic records. These electronic records have to be compliant with the set of FDA Code of Federal Regulations, the 21 CFR Part 11.

The industries in which this is needed are the following:

  • Pharmaceutical
  • Biotech
  • Medical device
  • CRO
  • Life sciences or related FDA-regulated organizations

Being knowledgeable about configuring an organization’s Excel spreadsheet application becomes a key requirement for organizations to not only meet FDA requirements, but avoid 483’s as well.

A word about 21 CFR Part 11

Complying with 21 CFR Part 11 is a quintessential part of validation of Excel spreadsheet application. 21 CFR Part 11 is a set of FDA requirements. The FDA requires compliance with this Part if the kinds of organizations shown above are to be considered as being compliant with their electronic records. These electronic records could be used for a variety of purposes, and hence their genuineness and authenticity is very crucial to ensure that they are the same as paper records.

Validation of Excel spreadsheet application is important because electronic records are prone to various kinds of manipulation. Staying compliant with 21 CFR Part 11 is what validation of Excel spreadsheets essentially means.

Since globally, organizations are graduating to electronic records and phasing paper records out; implementation of electronic records is inevitable. The long-term impact of paper records and the speed of communication make this even more so. It is estimated that when organizations validate Excel spreadsheet applications using appropriate and well-designed validation templates; they save up to two-thirds of the validation time and costs.

What does compliance entail?

The first step to this is configuring the organization’s Excel spreadsheet application as prescribed by the FDA. A risk-based validation approach is the right step, as it reduces and can even eliminate risks.

Coming to the validation of Excel spreadsheet applications, the organization should devise a methodology by which it creates these kinds of documentation into their Excel application:

validateExcelSpreadsheetApplication

Click to Continue Reading

Views: 25

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Forum

5 TECHNOLOGY-BASED LONE WORKER SAFETY SOLUTIONS

ABOUT 75% OF EMPLOYEES IN NORTH AMERICA ARE MOBILE WORKERS. ADVANCES IN COMMUNICATIONS TECHNOLOGY MEANS THESE WORKERS CAN WORK ANYWHERE AT ANY TIME. THESE NEW TECHNOLOGIES ALSO MEAN THESE MOBILE…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 31.

Road Safety Solutions 14 Replies

The Road Safety Signs ,Barriers,Humps,Hazard Markers and Visual Warnings are some of the important marks to be observed. Signs such as "keep left",stop, "give way" should not be casually treated.…Continue

Tags: safety, gear, wear, Equipment, &

Started by Enna Henry. Last reply by Jen McDade May 31.

Remote Monitoring

Get "Safe Assets and Sound Productivity" Through Remote Monitoring.Visit:…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 23.

Python Condition Objects Tutorial in 2018 1 Reply

If you have knowledge of other programming languages, then you would know the importance of conditional statements. Conditional statements are required for taking decisions. Whenever we operate the…Continue

Tags: course, certification, training, languages, programming

Started by Elena Lauren. Last reply by Jim Chesters May 15.

Power BI Visualization Types

Visualizations in Power BI displays the visual insights from a data. In power bi service a visual can be pinned from reports to create dashboards. Visuals are used in reports.List of visualizations…Continue

Tags: COURSE, TRAINING, BI, POWER

Started by Azharuddin May 15.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service