21CFR11 Compliant Software

May 21, 2024
A technician is trying to figure a cost to validate a CMMS.

HOW MUCH DOES IT COST TO VALIDATE A CMMS?

You’ve determined that your CMMS needs to be validated.  Then you’ve decided what functions you want to have.  Now, you have to make it happen and you have to see […]
May 15, 2024
how to validate and CMMS spreadheet

Can You Validate a CMMS Spreadsheet?

Challenges of Spreadsheet Validation in CMMS One question that comes up often in CMMS validation is: Can’t I just validate a CMMS spreadsheet to avoid the cost and hassle of […]
May 9, 2024
Validation of a Calibration Scheduling System

Which Calibration Scheduling Systems can be Validated?

WHY YOUR SMALL PHARMACEUTICAL COMPNAY MIGHT NEED A VALIDATED CALIBRATION SCHEDULING SYSTEM If you work in a small pharmaceutical, biotech, or medical device company, you may be using an unvalidated […]
August 25, 2019
protecting validated CMMS

Security and GMP SaaS Software

Use of SaaS based software is the trend in regulated industries as companies realize the great benefits of cost, infrastructure management, and flexibility. Providers can take a significant amount of […]
October 11, 2018

CMMS Systems: the Data Trap

Calibration and Maintenance Management Software (CMMS) Systems are intended primarily to keep your program on schedule and track your assets and documentation.  This requires entry of a minimal amount of […]
March 8, 2017

Operations Management Software Compliance

When discussing the compliance and qualification of management software for GxP operations, there are several aspects to consider. Terms such as 21CFR11, GxPs, and GAMP 5 are referenced in this […]