Asset and Calibration Management
We provide complete solution for managing the Quality Management of the Assets and related records.
This includes Calibration, PM(preventative maintenance), Qualification of the Assets.
Followings are key features and capabilities of our Asset Management system.
- Managing Calibration schedules and reports
- Managing calibration failures or out of tolerance conditions
- Notifications and monitoring for past due calibrations
- Location and status tracking of the assets
- Create and assign work orders, track status of the work orders
- Manage maintenance schedules and Retain the Maintenance records
More about our Asset Management Solution
The assets include gages, devices, equipment that is used for measurement of quality characteristics of products and services. The output from these measurements is data or information. The measurement data may be used for product release or acceptance. The quality of the measurement data directly depends on the quality of the measurement process. It is very important to make sure the gages or measuring devices are properly maintained and calibrated in regular intervals. This will help us preventing use of faulty gages, or devices that may lead to product recalls.
Given the number of assets used by the organizations, which can be 100s or 1000s, it is challenging to use the manual paper system to manage the assets.
When the assets are acquired or purchased, the assets need to be qualified and validated to confirm the organizational requirement. The assets need to be calibrated and maintained in regular intervals to keep functioning at the optimal condition.
If the asset fails (which is the reality, we live in), we should have a system to contain the impact of failures on the released or accepted products. We should also be able to take corrective actions to prevent the re-occurrence of the failures in the first place. Also we have to address the audit questions whether it is a planned audit or unplanned audit.
Highlights of Our Calibration System Capabilities
Managing Calibration schedules and reports- Not all gages or equipment’s are same. Some of them may need calibration every month; some may need once a year. We have to set them up correctly, so that it gets done every time. When the calibration is completed, an auditable report is available.
Managing calibration failures or out of tolerance conditions- When a piece of equipment fails, this needs to be identified and segregated to prevent further use. We need to identify the products and services that might have been impacted when the failed equipment/gage was in use. We need to segregate those material and service. Also we need to create record to investigate the root cause of the failure, so that we can implement corrective actions to prevent future re-occurrence. So there are many tasks and activities which need to be completed in timely manner.
Notifications and monitoring for past due calibrations- Yes, we do have these isolated situations, someone, somewhere forgot the piece of the gage. We need to have a system to track and send reminders to reduce the isolated cases.
Location and status tracking of the assets- Yes, we have many of these gages and Equipments. There are owners who change roles, jobs, locations. There are assets some are segregates, some are retired. We need to keep track of the updated status of the equipments/gages.
Create and assign work orders, track status of the work orders- If something breakdown, that needs to be fixed, we need to create work orders. The work order needs to be assigned and released. The status of the work order needs to be tracked.
Highlights of the Features and Options
Manage maintenance schedules and Retain the Maintenance records- We need to maintain the equipment’s/gages in proper conditions. The assets need preventative maintenance to prevent the failures. We have to set them up correctly, so that it gets done every time. When the preventative maintenance is completed, an auditable report should be available.
There are other systems available in the market which are not flexible or user friendly. We have developed a system that is easy to implement and easy to use. The system has built in features that enable compliance with regulatory requirements such as ISO 9000, 21CFR Part820, 21CFR part 211.
- User friendly- easy to use, easy to implement and configure. We have built in error proof mechanisms that prevents errors from happening during the use of the system
- The system has role based identification and log in and access control, which is very secured and convenient for use. Tasks or project will not wait for someone on a vacation…
- Workflow inbox capabilities provide easy visibility of notifications, tasks, and projects at a single place. You only see your tasks and notifications.
- The number of approvers can be different for each project, or you can assign minimum number of approvers and departments the approvers should be from.
- The System has E-signature capability that is audit-able and traceable
- Pdf printing capability with time stamps, and individual traceability
- Can attach as many files and any type of files. The records can be created using any type of files including audio and video files.
- No more painful scrolling or small text boxes…The users enjoy the benefits of drag and read text boxes. You can drag the boxes to read as much content you need.
- The system provides automated reminders for the task owner, project owners , approvers as per custom configurations
- The system provides options for creating metrics and reports. Export the data to Excel and create customized reports as needed, for management review, monthly, quarterly, or annual performance metrics.
- Option for configurable labels for the text boxes. You do not have to accept- this is how the system works.
"Qualcy EQMS is a simple and easy to use web based application for managing QMS functions for biotech companies."
Jack Diwu
Ph.D. President AAT Bioquest, Inc.
"Qualcy EQMS offers versatile and complete software solutions for managing QMS functions in the Biotech or Medical Device industry."
Laura Freeman
Senior Quality Manager, Bioserv
