Critical Alarm Management and Tracking Solution for Lifesciences Industries
Alarms play a crucial role in the Lifesciences Industry. They are carefully monitored because they can directly impact product quality. Generally, companies have well-documented processes for Alarm management. In today’s world of Pharma 4.0, It is quite challenging to manually monitor these alarms. If a manually monitored alarm fails to report an incident, then it can trigger 483 observations from US FDA. A lot of organizations that must follow proper alarm management, are a part of the life sciences industry. These include the pharmaceutical, biotech, biosimilars and API manufacturing industries.
Reference to alarm management systems can be found in EPA, OSHA and cGMP documents.
Significance of Critical Alarms Tracking in Lifesciences Industry
An alarm system is installed in an organization as a means to warn the workforce of an equipment failure or a procedural mishap. It helps companies reduce discrepancies or problems in the process which may require rework or may even cause product loss. So, we can say that it is a system designed to warn or alert and provide response procedures for unfavourable conditions, and process out of tolerance conditions and equipment failures.
Generally, alarm types are defined by operating plants. Typically, there are a minimum of two alarm types identified by most organizations. The first is a warning alarm and the second is a critical alarm
In Biotech companies, any disturbances experienced in the plant system leads to a deviation from the normal operating conditions. It implies that the system is working outside the normal operation range. With the help of an effective alarm system, the organization can be alerted about the deviation from normal conditions of environmental, product quality, and safety processes. These alarms are called as warning alarms.
If warning alarms are not addressed properly, the deviations will increase. When they reach the Proven Acceptance Range (PAR) as the system will switch to critical alarm. This alarm requires immediate attention from the necessary personnel to minimize critical effects
Example: Pharmaceutical companies or Biotech organizations have equipment like stability chambers, refrigerators, and incubators. Products are kept in a controlled environment in these equipment. Changes in the temperature can adversely affect the product quality and may even threaten the safety of the workforce and the equipment. An alarm system helps in quickly identifying abnormal temperature conditions so that prompt action can be taken to reduce the impacts of the temperature change.
Challenges in manual alarm management in Pharmaceutical & Biotech Industries
Alarm Management plays a very important role in assessing and managing the operational risks related with production facilities in the Lifesciences industry. They key is to have an effective alarm system in place because under performing alarms or inaccurate system can compromise your plant production and safety requirements.
- Pharmaceutical and Biotech companies will find it difficult to manually monitor the alarms because of excessive data availability from various control systems on the site.
- For example, a Biotech or a Pharmaceutical drug manufacturing plant will have thousands of alarms linked to the production equipment. In case of malfunctions in the system, will trigger and alert or a warning. If an operator ignores these warnings and continues production activities, a lot of issues may occur with the batch being manufactured. Manually monitoring these alarms can be a difficult task for the quality teams
- It is likely that a general manufacturing facility receives thousands of alerts or warnings through the alarm systems each month. . It is very frustrating for the plant operators to address these huge number of alarms effectively
- Categorizing and prioritizing the alarms according to their impact on product quality can be a concern for users who are trying to identify an effective response to the issue within time.
- With manual alarms records, there is a lack of insightful data related to batch wise, equipment wise and product wise information on alarms. This impacts efficient alarm management.
- A lot of times, operators fail to recognize critical alarms which may require immediate response from alarms that do not need them to respond. Consequently, the responses to critical alarms may suffer a delay impacting product quality and business profitability.
US FDA 483 observations on critical alarm management in GMP Manufacturing Facilities
Recently, the US FDA has recognized through their audits that companies are falling short on their adherence to alarm systems. This has led to warning letters being issued to the organizations for better alarm management systems which comply with the regulatory requirements. Few of these observations include
- Lack of data which can demonstrate the performance of alarm as expected in different environmental conditions
- Inadequate system to relay alarms to the operators when the alarms send warnings or alerts during after-hours and on weekends
- Alarms for out of temperature specification events are audible only in the vicinity of the equipment..
GMP Guidelines for alarm management systems
FDA’s guidance for alarm management can be observed in two of its guidelines
- Computerized systems in Drug establishment(2/83).
- General principles of software validation; final guidance for industry and FDA staff, January 11, 2002.
Few expectations of FDA regarding alarm management
- Documenting the alarm functions like the condition that triggers the alarm as well as interlocks which can initiate an alarm to warn operators.
- Proper documentation of the alarm parameters which can include pre-defined set points that trigger an alarm as per the process requirements.
- Documentation of alarm responses and their procedures.
- Defining alarm recording procedure by automated systems and maintenance of historical record.
- Documentation of design, validation and maintenance of alarm user interface to ensure its functionality as per the requirement.
- Proper design of alarm interface for addressing all alarms without any delay.
Critical Alarms Tracking Software Features
- AmpleLogic Alarms Management Solution is fully compliant with US FDA 21 CFR Part 11, MHRA EU Annex 11 and other regulatory standards.
Comprehensive electronic log sheet
- AmpleLogic Pharma Alarm Management Software features a detailed log sheet which will allow you to capture information such as unit, block, equipment name, equipment code, batch no etc. along with the alarm details..
- Our Critical Alarm Management Software helps companies Structure alarm records. This is done by adding details like the alarm type, priority of the alarm, lot number and other details relevant to the process other than timestamp. In doing so, alarm records can easily be tracked and analyzed.
Documentation of alarm details
AmpleLogic Alarm Recording Software helps you to document
- Alarm functionality
- The potential cause of alarm
- Alarm interlock details
- Set points or parameters or thresholds
- Escalation procedure and
- The ability to document allowable response time as well.
- AmpleLogic Alarm Recording and Tracking software helps users easily translate complicated data into visual information which can be customized according to KPIs. This helps in better decision making process.
Our alarm recording software helps to monitor different alarms and their root causes and possible actions to be taken to handle the situation
Batch Wise Alarm Data
- Analyse data to get key insights about the functionality as well as the performance of the alarms – both critical and warning alarms – for every batch
- Data analysis based on lot number is often performed in many pharmaceutical industries which helps to compare different lots. This helps users easily look up batch-wise information about the alarms to track abnormal situations that occurred during a batch
Equipment Wise Alarm Data
With the help of our alarm tracking software, you can easily analyse alarm data for the equipment to monitor the performance, risks and deviations which may occur in each equipment in the plant.
Generate alarm reports which help in providing the organization with useful insights which can help in improving 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 take advantage of Alarm Tracker
- Medical Devices
- Contract Manufacturing
- General Manufacturing
- Food & Beverages
If you would like to discuss how your AmpleLogic Alarm Management Solution can improve your business efficiency, then please contact us.