Use Cases

Growing your operations has never been this easy.

Keep your options open with GxPReady! Suite.  Make it easy on yourself to keep up with your physical assets, calibration, validation, and maintenance.  GxPReady! Suite makes it far easier for our customers to configure, track and perform asset management. Browse these use cases and see if its time for you to give us a try with a demo or free trial!

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Imagine your company has been hit with one or more observations related to its calibration, maintenance, or validation management systems.   Operations have been delayed until the issues can be resolved.  A follow up inspection may be pending.  Required remediation may include development of additional procedures, forms, reports, training, and the qualification of the scheduling system to meet GMP requirements including 21CFR11 and/or Annex 11 requirements.

Use GxPReady! Suite to get your asset management on track quickly with a pre-qualified tracking system  supported by training, forms and practices.   Address observations and resume operations quickly to focus on core competencies and mission.  Continue to grow without  interrupting ongoing IT infrastructure operations.  You’ll be back on track in no time! 

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A Small, Growing Pharmaceutical Company

Perhaps your company has been keeping track of its calibration and maintenance using spreadsheets, log books, or just by periodically reviewing their inventory and scheduling work as needed.  The equipment and documentation are manageable.  As the company grows, the product(s) proceed through various trials and the requirement for compliance increases.  Asset management becomes more challenging with more equipment, more people, but the same old tracking system.

Spreadsheets and log books for scheduling maintenance are more difficult to manage.  Management of the schedule with various departments and follow up on Out of Tolerance events requires more effort.  The prospect of validating the various spreadsheets on top of all of the other work performed day to day becomes daunting, and traceability is cumbersome if its even possible.  Don’t start from scratch creating a validated IT infrastructure and incur the expense and delays.  The risk of non-compliance becomes more and more real as the company proceeds through the approval process for their product(s).

Use GxPReady! Suite and you quickly have  a validated tracking system for validation, calibration, and/or maintenance at your disposal with minimal cost.  The system is easy to secure, operate and includes required validation and audit trails.  Increase productivity and focus on the core competencies that got you this far.

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A Large Company Acquiring Smaller Companies

Here you have an established, compliant system for managing its operations, including calibration, validation, and maintenance.  The company acquires a smaller operation which may be located in another state or country.  Don’t face the prospect of trying to integrate the smaller company into your systems, or develop separate systems for the smaller company with all the attendant challenges and costs.

GxPReady Suite provides you the solution which allows the smaller company to use the web based system without having to worry about integrating into the established procedures and software developed for the parent company.  Don’t risk the infrastructure of the parent company bring in the smaller company.  Use GxPReady and you can both be compliant!

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A Company that is Moving to a New Facility or Greenfield Site

Your new company has an established, compliant system for managing its operations, including calibration, validation, and maintenance.  The company is growing or moving to a new location.  You face  the prospect of moving or expanding the existing validated IT infrastructure to be able to continue operations.  How do you get a system up and running while the assets you need to manage are being ordered and put in place one after the other, and there isn’t even an IT room at the new site yet!

GxPReady Suite provides validated software prior to the move, or even during construction of a new facility.  Equipment assets can be entered into the database as it is moved/acquired and the company seamlessly supports the startup of the facility as it is built!  The move works because all parties can have access to information they need about the status of equipment.

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A Growing Contract Manufacturing Organization

Your company is a contract manufacturing organization (CMO) that is growing and experiencing more customer audits as they bring on new business.  Their current calibration, maintenance, and validation tracking system is cumbersome and does not provide sufficient or convenient  traceability of changes.

Don’t stress!  GxPReady Suite solves this problem by providing a convenient, easily accessible system to manage the calibration, validation, and or maintenance systems, using forms and reports that are familiar to the industry and that support streamlined and efficient practices. 

WATCH THE CASE 5 VIDEO
Use Cases

A Company That Desires to Use Different Software for Tracking Calibration, Maintenance, and/or Validation

All companies are different.  You may have managers for departments that already have a solution for asset tracking, and others that do not.  For example, the calibration department may already be using a tracking system, but that system won’t work for maintenance.  Maybe the departments are in different levels of development.  In any case, a “one size fits all” approach for software will not work within the company because each department prefers a separate solution.  In addition, IT may have requirements that impact any solution that is installed in-house.  So it becomes difficult to agree on a software package.  Don’t get in that situation.

GxPReady Suite solves this problem by allowing access to our qualified system via a secure internet connection and the ability to select only the modules required for the company to use.  For example, if you only need the calibration tracking module, it doesn’t impact other departments within the facility like a “one size fits all” package would.  In addition, you can activate other modules as required FOR NO ADDITIONAL COST.  This model also reduces the impact on IT operations within the company facility.

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A Company Seeking Consensus for the Perfect CMMS Software

If you are in the process of due diligence to select the software package that is perfect, you might be building consensus and reviewing options, cost projections, impacts on other systems, and integration potential, in addition to authorizing the funds.  Meanwhile, using an outdated system that is difficult to maintain and exposes the company to compliance risks.

Keep you options open with GxPReady! Suite.  It provides you a validated CMMS solution that will support compliance until you determine the perfect final solution for your company.  With minimal upfront and ongoing costs and resource requirements, and no long term commitment, plus the ability to export data that can be subsequently imported by a future solution, there is really no down side to staying compliant with GxPReady! Suite. Take your time and pick the best long term solution.  Perhaps GxPReady! Suite will serve the company’s long term needs as well, as it has for a large percentage of our customers!  Contact us for more information, a demo, or a free trial!

WATCH THE CASE 7 VIDEO