There are several types of problems that GxPReady Suite can solve for our customers:
Case 1: A Company Recovering From a Customer Audit, 483 Observation, or Consent Decree QUICK VIDEO EXPLAINER
This company has been hit with one or more observations related to its calibration, maintenance, or validation management systems. Some example observations can be found here. 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 requirement including 21CFR11, and/or Annex 11 requirements.
GxPReady Suite provides this company a solution that will get them back on track quickly with a pre-qualified tracking system they can access, supported by training, and forms and practices that are based on experience in the industry. The company can provide secure access to authorized individuals to allow all stakeholders to see information about their equipment. The company can resume operations more quickly and can focus on its core competencies and mission and continues to grow without interrupting ongoing IT infrastructure operations.
Case 2: A Small, Growing Pharmaceutical Company QUICK VIDEO EXPLAINER
This 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 and progresses, the product(s) proceed through various trials and the requirement for compliance increases. Spreadsheets and log books for scheduling maintenance may become more difficult to manage, and additional effort is required to remain on top of things. 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 perfomed day to day becomes daunting and traceability of changes performed to the spreadsheets increases overhead. Giving authorized employees access to information about their equipment may become difficult while maintaining control. The idea of creating a validated IT infrastructure adds to the potential expense and delays, yet the risk of non-compliance becomes more and more real as the company proceeds through the approval process.
GxPReady Suite provides this company an option: a validated tracking system for validation, calibration, and/or maintenance that can be started up quickly and without having to get approval for large up-front expenses. The company can provide secure access to authorized individuals to allow all stakeholders to see information about their equipment. In addition, the system meets qualification requirements and streamlines the effort when compared to the current procedures. The company becomes more productive and can focus on its core competencies and mission and continues to grow without the worry of non-compliance in this area or interrupting ongoing IT infrastructure operations.
Case 3: A Large Company Acquiring Smaller Companies QUICK VIDEO EXPLAINER
This company has an established, compliant system for managing its operations, including calibration, validation, and maintenance. The company acquires a smaller company which may be located in another state or country. The parent company faces the prospect of trying to integrate the smaller company into its systems, or develop separate systems for the smaller company with all the attendant challenges and costs.
GxPReady Suite provides the parent company a solution which allows the smaller company to use the web based system without having to worry about integrating the small company into the established procedures and software developed for the parent company. Furthermore, there is no risk to the infrastructure of the parent company related to bringing the smaller company on board. This provides the parent company flexibility in the timing of integration of the smaller company while maintaining or improving compliance.
Case 4: A Company that is Moving to a New Facility or Greenfield Site QUICK VIDEO EXPLAINER
This company has an established, compliant system for managing its operations, including calibration, validation, and maintenance. The company desires to move to a new location or open a new facility. The company is facing the prospect of moving or expanding the validated IT infrastructure to be able to continue operations. This requires a significant investment of resources and scheduling problems as the new facility needs to be prepared before the IT infrastructure can be put in place to allow implementation of the tracking software.
GxPReady Suite solves this problem by allowing the company to begin using validated software prior to the move, or even during construction of a new facility. Equipment that requires calibration, validation and/or maintenance can be entered into the database as it is moved/acquired and the company can seamlessly support the startup of the facility without having to wait for the new IT infrastructure to be built. The overall move is significantly smoother because all parties can have access to the information they need about the status of equipment.
Case 5: A Growing CMO
This company is a contract manufacturing organization 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, convenient, traceability of changes, or the system may not be familiar to auditors, leading to confusion of forms and processes.
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. This gives our customers a head start in addressing theses growing pains.
Case 6: A Company That Desires to Use Different Software for Tracking Calibration, Maintenance, and/or Validation
This company may have managers for these departments that already have a solution, 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. Alternatively, perhaps 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.
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 it only needs the calibration tracking module, that’s all the company pays for and it doesn’t impact other departments within the facility like a “one size fits all” package would. In addition, the company can add the other modules if/when that is appropriate for the company. This model also reduces the impact on IT operations within the company facility.
Case 7: A Company Seeking Consensus for the Perfect CMMS Software
This company is working through the due diligence to select the software package that is perfect for the long-term goals of their company. They are building consensus and reviewing options, cost projections, impact on other systems, and integration potential, in addition to authorizing the funds. In the interim, they are using an outdated system that is difficult to maintain and may expose the company to compliance issues.
GxPReady! Suite provides this company a validated CMMS solution that will allow them to remain compliant for as long as necessary to determine the perfect final solution for them. 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 to allow company the time to make sure it pick the best solution. It may be, in fact, that GxPReady! Suite will serve the company’s long term needs as well, as it has for a large percentage of our customers!