Which Calibration Scheduling Systems can be Validated?

Validation of a Calibration Scheduling System

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 calibration scheduling system. Maybe you are using a spreadsheet or a CMMS system that is for general use.

CHALLENGES IN VALIDATING WEB-BASED SOFTWARE SYSTEMS

How do you validate a calibration scheduling system? Validating software not designed for validation is quite challenging. The validation work mainly takes place during the software’s development lifecycle, well before you access the software. This lifecycle involves defining and documenting requirements, ensuring the involvement of qualified personnel, and maintaining written, approved procedures throughout the software’s development, deployment, and use. This process is especially difficult for web-based systems, as their installation locations are often unknown, and the software manufacturer may not control the hardware. Moreover, even if you acquire non-validated software that fits your needs, it’s unlikely to provide necessary support during critical times, such as audits.

EXPLORE GXPREADY SUITE: YOUR GATEWAY TO EASY SOFTWARE VALIDATION

If you need validated software, it is best to find some software designed for this purpose that meets your requirements.  Companies like GxPReady have developed and designed calibration, validation, and maintenance software to meet FDA requirements using a combination of patented methods and systems that make it really easy for you to get up and running quickly without breaking the bank. You can get more information about GxPReady Suite calibration, validation and scheduling software on the web site at gxpready.com.

GXPREADY SUITE: BALANCING COMPLIANCE, COST AND USABILITY

Other companies also offer systems designed to meet FDA and EMA requirements. We recommend that you do your due diligence and sort out the costs, timelines, and features of each so you can best match to your situation.  You will need to know how many users you plan to have using the system, and which features are critical to you.  Keep in mind that you can perform non-gmp work outside of the validated system, so your validated software doesn’t need to do everything!  If your company is small to mid-sized, we believe you will find that GxPReady Suite has a good balance of functionality, ease of use, and compliance for a very low cost.  Check out GxPReady.com for additional information or contact us directly at [email protected].

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