Software Validation

March 13, 2024
A maintenance technician is checking on the cost of a validated maintenance scheduling software.

What is the cost of a Validated Maintenance Scheduling Software?

  The Importance of FDA/EMA-Compliant Validated Maintenance Scheduling Software In the competitive landscape of the medical device, biotech, and pharmaceutical industries, ensuring operational efficiency while maintaining compliance with FDA and […]
March 2, 2024
a maintenance technician is getting an equipment maintenance request on the phone because he does not use asset management software

GxPReady! GMP Asset Management

GxPReady! Suite is a great solution for GMP Asset Management in small to mid sized companies.  If you are working with paper records or electronic spreadsheets to keep track of […]
February 16, 2024
Don'l let production stop. Use your validated CMMS to support production as and document your decisions.

Use Your Validated CMMS to Support your Asset Management and Operations Activities

  Ensuring GMP Compliance Amid Operational Challenges In the realm of operations, unexpected events can disrupt carefully laid plans, particularly when it comes to maintaining and calibrating essential equipment. The […]
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 […]
April 12, 2018

5 Significant Potential Audit Issues with CMMS Programs

As a manager of your company’s calibration and/or maintenance management system (CMMS), part of your responsibility is to ensure that you are as prepared as practical for any review of […]
March 25, 2017

GxPReady Suite Provides Several Advantages Compared to Traditional CMMS Systems

GxPReady Suite provides qualified software as a service (qSaaS) for use in FDA regulated industries.  This has several advantages over traditional approaches to software validation and overcomes the following problems: Beat […]
March 8, 2017

Software Validation: Harder Than it Has to Be

Selecting and validating a software program for GxP use can be a daunting process, but the basic steps seem uncomplicated, and indeed, the basic concept is straightforward, comprised primarily of […]