Calibration and PM

Calibration Schedules Management & Tracking Software for Life Sciences

All instruments associated with the processing and testing of materials and products need to be calibrated. A paper calibration record information includes time, date, calibrated on, next calibration, etc. which is tedious to manage. This paper driven tracking of Calibration schedules may lead to audit observations. Despite conformance with the regulations, paper documentation is cumbersome and prone to human error. AmpleLogic calibration schedules management and tracking solution makes sure that the calibration of instruments and preventive maintenance of the equipment are performed correctly and in a timely manner. Our Calibration Tracking Software complies with 21 CFR Part 11, EU Annex 11 regulatory bodies and helps businesses improve productivity, reduce workload and create an effective calibration program.

Calibration Schedules software is developed on AmpleLogic’s LOW CODE PLATFORM which uses modern and advanced technologies. The solution is configured to meet customers’ business processes enabling them to plan, manage, analyse and document all calibration work and assets safely and efficiently.

AmpleLogic Calibration Schedules Tracking Software supports organization in streamlining calibration cycles and adhering to regulatory policies related to preventive maintenance schedules for all equipment. It helps in scheduling and generating timely reminders on upcoming re-calibration of the instruments, recording the results of calibration activities and creating certifications in compliance with regulatory standards.

This calibration software ensures compliance with GMP processes that must be followed by pharmaceutical, life sciences and medical device industries. It also maintains log of all activities for audit purpose.

GMP Environments Current Challenges in Equipments Preventive Maintenance and Instruments Calibration

At this time, several organizations in the industry are limited to the use of excel sheets for maintaining calibration and preventive maintenance schedules. Managing huge volumes of information related to the schedules using excel sheets is quite challenging and leads to unnecessary calibrations or missed calibration cycles. From the quality point of view, missing the calibration schedule leads to deviations and the cost of deviation in the Lifesciences and Biotech industry is very high. An out of calibration equipment or instrument part has a direct impact on product (medicines/drugs) quality. It also  increases  operational costs because the equipment are prone to breakdowns. Production delays due to breakdown may result in back orders.

Product, process and safety instruments are required to be physically tagged and sometimes color-coded. Due to a large number of equipment and instruments, there is no proper visibility on the usage logs along with real-time calibration and Preventive Maintenance (PM) status for the instruments.

Our team of experts understand the need for dissolving these industry challenges. We have developed a powerful software designed to meet the calibration management requirements to meet your organization’s needs.

AmpleLogic Calibration and Preventive Maintenance Software Features

  • Record Equipment Master’s details including equipment details and the preventive maintenance intervals.
  • Annual Preventive Maintenance (PM) schedule generation for all equipment in manufacturing blocks and Quality Control (QC) departments that include major equipment and PLCs.
  • Create, update, or negate schedules from any point in the equipment life cycle process. AmpleLogic Preventive maintenance schedules Tracking Software also prioritizes the schedules based on urgency.
  • AmpleLogic Calibration Schedule Management system will be able to provide complete visibility for the usage logs along with real-time information regarding the status for equipment, instruments 
  • The software includes a separate process flow that users must follow when an equipment is out of calibration or it has been abandoned. It also includes a workflow for equipment retirement.
  • Summary of entire instruments service history will be auto generated along with the calibration dates and the activities performed during calibration.
  • With the click of a mouse, you will be able to see the equipment due for Preventive Maintenance.
  • A color coded scheduling calendar makes it easy to see your calibrations, maintenance activities, current status of calibrations and PM, next due date of a calibration, last date of a calibration, failed calibrations, service requests, and upcoming calibrations. It also helps you identify records that are overdue for calibration.
  • The calendar schedule will enable you to view current, upcoming calibration and preventive maintenance schedules based on location, and department.
  • You can easily monitor the status of investigations for out of calibration (OOC) records and implement a proper corrective action in a timely manner.
  • It will automatically calculate calibration due dates according to user defined intervals and set calibration frequency to any number of days, months or years and define how they want the due date to be calculated
  • It will assure that the spare parts, materials, and other inventory levels are up to date and readily available to use whenever they are required.
  • Calibration and Maintenance Management Software allows to print calibration tag after successful calibration.
  • AmpleLogic Calibration Tracking Software will auto generate calibration completion certificates.
  • Reports are auto-generated along with email alerts to notify users of calibrations which are due and those that have been delayed. You will also find details of calibration exceptions made during the period of the report.
  • Can be easily integrated with Manufacturing Execution Systems(MES) and Electronic Batch Manufacturing Records (eBMR).
  • The system improves efficiency and reduces equipment idle time by grouping calibration schedules for similar equipment together. It does the same for production block wise equipment.
  • Auto-generation of the Instrument master’s historic data related to calibrations and preventive maintenance. The records include a unique identity, calibration period and the next due date of calibration or PM for every equipment.
  • It helps organizations maintain accurate logs in adherence with the approved standards and the organization’s SOPs. You can also review and verify equipment logs easily using the software.
Performance Reports
Calibration StatusOut of Calibration (OOC) Report
Calibration Completion ReportPM Scheduler Report
Calibration Due ReportsCalibration Scheduler Report
Calibration Completion ReportYearly wise report
Equipment Lifetime ReportInstrument Lifetime Report
Instrument Annual Block Wise Schedule ReportEquipment Annual Block Wise Schedule Report
Equipment Status Schedule Wise ReportCalibration Plan Block Wise Count Report
Master list of instruments/equipmentsConnected Equipment details report

 

Benefits of Calibration Schedules and PM Automation Software in drug manufacturing

  • Calibration software supports your organization’s need to comply with the policies and regulations laid down by authorities like the US FDA, 21CFR Part 11, MHRA, and WHO.
  • The calibration software features a calendar which provides users with a clear visual of the calibration schedules on a yearly, monthly and weekly basis.
  • It schedules automatic e-mail notifications on or before calibration due dates. This alerts the production and QC teams to plan their work and avoid deviations due to schedule slippage.
  • Maintains Calibration, and Maintenance of Equipment Logs
  • Calibration logs will provide controlled access for data to users based on their roles in the departments
  • The dashboard provides clear and concise knowledge of the calibration schedule and its effectiveness. It also gives a snapshot of process health to senior management and head of departments.
  • It also assists in tracking preventive maintenance and breakdown history, which in turn, helps in tracking the complete history of the equipment at the same time with calibration Status.

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

Other industries that can take advantage of Preventive Maintenance Schedules Management Software

  • Biologics
  • Medical Devices
  • Chemical
  • Contract Manufacturing
  • General Manufacturing
  • Food & Beverages

If you would like to discuss how your business can benefit from AmpleLogic Calibration and Preventive Maintenance Software, please contact us.