Validated Software Development

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 […]
April 22, 2017

Hidden Costs of Validated CMMS Systems

Validated CMMS or QMS systems come in many forms including custom coded, locally installed, and some internet and/or cloud based systems.  Each of these has advantages and disadvantages, of course, but […]
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 […]
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 […]