Manage multiple sites at one time and Automate tracking of scheduled maintenance on every machine
Calibration is important for all equipment used in the processing and assessment of resources and products. Time, date, calibration date, and next calibration are all included in a paper calibration record that is cumbersome to keep track of. This paper-based recording of calibration schedules may result in audit observations. Documentation on paper is tedious and vulnerable to human mistakes, even if it is compliant with rules.
To ensure that instruments are calibrated correctly, the AmpleLogic Calibration and Preventive Maintenance Solution ensures that preventative maintenance of the equipment is conducted accurately and on time. With our Calibration Management and Tracking Software, organizations can increase efficiency, decrease burden, and develop an efficient calibration program that conforms with 21 CFR Part 11 as well as EU Annex 11 regulations.
Calibration and Preventive Maintenance (CAPS) Software is built on AmpleLogic’s LOW CODE NO CODE (LCNC) PLATFORM, which employs cutting-edge technology. In order to ensure that all calibration programs and resources are managed securely and efficiently, the system is designed to meet the customers’ business requirements.
AmpleLogic Calibration and Preventive Maintenance Software assists organizations in simplifying calibration processes and complying with regulatory standards governing precautionary maintenance schedules for all instruments. It aids in the planning and generation of prompt notifications for impending equipment re-calibration, the documentation of calibration activities outcomes, and the creation of certificates under regulatory requirements.
This Equipment Calibration Software guarantees that the pharmaceutical, contract development and manufacturing organization (CDMO), life sciences, medical devices, contract research organization (CRO) and biotech companies adhere to GMP standards. It also keeps a record of all actions for verification purposes.
Several organizations in the industry still rely on Excel spreadsheets to keep track of calibration and preventative maintenance plans. Excel sheets can be difficult to manage when dealing with large amounts of scheduling information. This might lead to having needless calibrations or even losing some calibration cycles.
Missing the calibration schedule results in deviations, and the price of variation in the Life Sciences and Biotech business is quite high. Instruments that are not calibrated can have a direct influence on the quality of a medication or drug. There is also an increase in operational expenditures due to equipment failures. Backorders may occur as a result of production delays caused by a breakdown.
Instruments used in manufacturing, process control, and safety are expected to be visually labeled, and sometimes tagged for color, for identification purposes. It’s difficult to keep track of usage records, as well as Calibration and Preventive Maintenance (PM) for all of the instruments due to their sheer quantity.
The experts on our team are well-aware of the necessity to solve these industrial problems. We have created a robust program that is developed to fulfill the calibration management requirements of your company.
|Calibration Status||Out of Calibration (OOC) Report|
|Calibration Completion Report||PM Scheduler Report|
|Calibration Due Reports||Calibration Scheduler Report|
|Calibration Completion Report||Yearly wise report|
|Equipment Lifetime Report||Instrument Lifetime Report|
|Instrument Annual Block Wise Schedule Report||Equipment Annual Block Wise Schedule Report|
|Equipment Status Schedule Wise Report||Calibration Plan Block Wise Count Report|
|Master list of instruments/equipment’s||Connected Equipment details report|
AmpleLogic Calibration Schedules Software will also comply with electronic Record standards defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA and MoH
Feel free to contact us if you’d like to learn more about how AmpleLogic Calibration and Preventive Maintenance Software may help your company