Calibration Management Software

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 schedules tracking system 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 Schedules Software is built on AmpleLogic’s LOW CODE 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 Management 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 Calibration Software guarantees that the pharmaceutical, life sciences, and medical device companies adhere to GMP standards. It also keeps a record of all actions for verification purposes.

Maintenance of Equipment and Instrument Calibration in GMP Environments : Current Challenges

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.

Features of AmpleLogic Calibration and Preventive Maintenance Software

• Keep a record of the Equipment Master’s information, including equipment details and preventative maintenance frequencies
• Create annual Preventive Maintenance (PM) schedules for all equipment in production blocks and Quality Control (QC) departments, including large machinery and PLCs.
• Schedules can be created, updated, or rejected at any stage in the life cycle of the equipment. The AmpleLogic Preventive Maintenance Schedules Tracking Software also gives prominence to the schedules depending on their importance
• The AmpleLogic Calibration Schedule Management system can give full visibility for usage logs as well as real-time information on the state of equipment and devices.
• When a piece of equipment is out of calibration or has been dumped, the software offers a distinct process flow that a user must follow. It also features a procedure for discarding equipment.
• An overview of the whole instrument’s maintenance records, as well as the calibration dates and activities performed in the process of calibration, will be automatically created.
• Equipment due for Preventive Maintenance can be viewed with just a click of a mouse.
• Calibrations and maintenance activities can be easily identified with the help of a color-coded scheduling calendar, which shows the present situation for calibrations and maintenance activities as well as the next due and the last date of calibration. It can also help you find records that would need to be calibrated soon.
• You can examine ongoing and forthcoming calibration and preventive maintenance routines depending on location and department using the calendar schedule.
• You can effectively track the progress of inquiries for out of calibration (OOC) records and take appropriate remedial action in a timely way.
• A user can specify the calibration intervals (days, months, or years) and how they want the timeframe to be computed. It will automatically generate the calibration target date based on these user preset intervals.
• The system ensures that accessories, supplies, and other inventory levels are current and ready to use whenever they are needed.
• After successful calibration, Calibration and Maintenance Management Software enables you to print a calibration tag.
• Calibration completion certificates will be created automatically by AmpleLogic Calibration Management System.
• Automatically generated reports and email alerts inform users when calibrations are due and when they have been postponed, allowing them to plan in advance. You will also learn about the calibration errors that occurred during the reporting period.
• It is simple to integrate with Manufacturing Execution Systems (MES) and Electronic Batch Manufacturing Records (EBMR).
• By putting calibration cycles for matching equipment together, the system increases efficiency and decreases equipment idle time. It operates in the same way for manufacturing block-wise equipment.
• Automatic generation of previous calibration and preventative maintenance data from the instrument master. For each piece of machinery, the data include dynamic properties, calibration period, and the next calibration or PM due date.
• It aids companies in keeping accurate records in accordance with authorized regulations and the SOPs of the organization. The software also allows you to seamlessly examine and validate equipment records.

The Advantages of Calibration Schedules and PM Automation Software in Pharmaceutical Production

• Calibration Software helps your company in meeting the guidelines and requirements established by authorities such as the US FDA, 21CFR Part 11, the MHRA, and WHO.
• With the help of the calibration calendar, users can see the calibration schedules on an annual, monthly, and weekly frequency.
• It sends out automated email alerts on or before calibration due dates. This notifies the production and quality control teams, allowing them to better organize their work and minimize delays caused by slippage in the plan
• Calibration and equipment logs are kept up to date.
• Restricted data access is given to users through the calibration logs depending on their departmental positions
• The dashboard makes it easy to keep track of the calibration schedule and how well it is working. Senior management and department heads can also get an overview of the state of the process with this system.
• Preventive maintenance and failure history can be tracked with the system, which assists to keep track of the equipment’s whole history, along with its 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 benefit from Preventive Maintenance Schedules Management Software include

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

Feel free to contact us if you’d like to learn more about how AmpleLogic Calibration and Preventive Maintenance Software may help your company