Alarm Management System

Challenges in manual alarm management in Pharmaceutical & Biotech Industries

Alarm Management is critical in analyzing and controlling operational hazards associated with manufacturing facilities in the Life Sciences industry. Knowing fully well that poor alarm functionality or an unreliable system could jeopardize your plant’s productivity and safety requirements, it is imperative to have an effective alarm system in place.

• Because of the abundance of data available from multiple control systems on the site, pharmaceutical and biotech businesses will find it almost impossible to manually monitor the alarms.
• A Biotech or Pharmaceutical drug manufacturing industry, for instance, will have thousands of alarms connected to the production equipment. In the event of a system fault, an alert or warning will be triggered, and if an operator overlooks these warnings and continues with production, several problems may arise with the batch being made. Monitoring these alerts manually may be a challenging task for quality teams.
• Each month, a general manufacturing facility’s alarm systems are likely to receive thousands of notifications or warnings. It is quite difficult for plant operators to appropriately handle such a large number of alarms.
• Users who want to find a quick and efficient solution to the problem may be concerned about categorizing and prioritizing the alerts based on their influence on product quality

• There is a lack of useful data linked to information about batch, equipment, and product alarms. This has an effect on efficient alarm management.
• There are many times when operators are unable to differentiate between urgent alarms that demand quick action and alarms that do not. As a result, responses to important alarms may be delayed, affecting product quality and corporate profitability.

Observations of the US FDA 483 on Critical Alarm Management in GMP Manufacturing Facilities

Recently, the United States Food and Drug Administration (FDA) discovered that some organizations are not adhering to alarm systems through assessments. As a result, companies have received warning letters requiring them to improve their alarm management systems in order to meet statutory requirements.

Among these observations are:

• There is insufficient data to demonstrate the functionality of the alarm as expected under various environmental conditions
• Inadequate system for transmitting alarms to operators after working hours and on weekends when alarms send warnings or alerts
• Only those near the device will be able to hear alarms if the temperature falls outside of the specified range

GMP Guidelines for Alarm Management Systems

FDA’s guidance for alarm management can be observed in two of its guidelines

Two of the FDA’s guidelines on alarm management provide recommendations for alarm management.

• Computerized systems in Drug establishment(2/83).
• General principles of software validation; final guidance for industry and FDA staff, January 11, 2002

Here are some of the expectations of the FDA concerning alarm management:

• Detailing alarm functions such as the circumstance that prompts the alarm and interlocks that can cause an alarm to notify operators
• An adequate record of the alarm parameters, which may include predefined configuration settings that trigger an alarm following to the process requirements
• Alarm responses and procedures should be documented
• Automated systems and maintenance records should be used to specify alarm recording
• Design, verification, and maintenance of the alarm user interface should be  documented to ensure that it functions as required
• The alarm interface should be properly designed to handle all alarms without delay

Features of Critical Alarm Tracking Software

Regulatory compliance

• The AmpleLogic Alarms Management Solution complies fully with US FDA 21 CFR Part 11, MHRA EU Annex 11, and other regulatory requirements.

Comprehensive electronic log sheet

• You can record information such as unit, block, equipment name, equipment code, batch number, and so on alongside alarm information in AmpleLogic Pharma Alarm Management Software’s comprehensive log sheet.

• By including data such as the alarm type, urgency of the alarm, lot number, and any information important to the process (besides the timestamp), our Critical Alarm Management Software helps organizations in structuring their alarm records. This makes alarm recordings easily tracked and evaluated.

Documentation of alarm details

AmpleLogic Alarm Recording Software helps you to document the following:

• Alarm utility
• The possible reason for the alarm
• Specifications for alarm interlocks
• Setpoints, parameters, or thresholds
• Process of escalation, and;
• The capacity to also record maximum/minimum response time

Customized reports

• AmpleLogic Alarm Recording and Tracking software allows users to easily interpret complex data into visual information that can be modified based on key performance indicators (KPIs). This aids in making better decision process.

This alarm recording software of ours helps in the monitoring of various alarms, their main sources, and possible corrective or preventive measures to be taken to address the problem.

Batch Wise Alarm Data

• Analyze data to gain crucial insights into the functioning and performance of both critical and warning alarms for each batch.

• Many pharmaceutical organizations do data analysis based on lot numbers, which enables them to compare various lots.  This helps the user to easily search batch-wise information about the alarms to detect anomalies that took place during a batch.

Equipment Wise Alarm Data

You can easily analyze alarm data for the equipment using our alarm tracking software to monitor the effectiveness, dangers, and deviations that may arise in each piece of equipment in the plant.

Create alarm reports to assist the organization in giving helpful insights that can be used to improve the systems in the process

AmpleLogic Critical Alarm Tracking 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 Alarm Tracker are

• Biologics
• Medical Devices
• Contract Development and Manufacturing Organization (CDMO)
• Chemical Industry
• Contract Manufacturing
• Generics
• General Manufacturing
• Contract Research Organization (CRO)
• Food & Beverages

Please contact us if you would like to learn more about how AmpleLogic Alarm Management Solution can increase the efficiency of your organization.