Alarm Management Solution for Lifesciences Industries
Alarms in the Lifesciences Industry is one of the key parameters to be monitored as it has got a direct impact on Product Quality in most of the cases. Generally, these industries have well document process for Alarm management. In today’s world of Pharma 4.0, It is quite challenging to keep track on these alarms manually. Any failure in ensuring the proper functioning of these Critical Alarms will lead to 483 Observations from US FDA. Many of the process industries belong to the life sciences sector such as Pharmaceutical, Biotech, Biosimilars and API manufacturing industries will also have regulatory requirements to be taken care of.
Reference to alarm management systems can be found in EPA, OSHA and cGMP documents.
Significance of Alarm System in Lifesciences Manufacturing Industry
Alarm systems are generally implemented to warn against the process and equipment failure to prevent discrepancies, rework and ultimately product loss. These observations give us a comprehensive definition of an alarm as a system designed to warn or alert and provide response procedures for unfavourable conditions, process out of tolerance conditions and equipment failures.
Critical alarms and warning alarms
Generally, alarm types are defined by operating plants. Although a Minimum number of alarms required are two i.e., warning alarm and critical alarm.
In Biotech industries Often disturbances caused in plant systems will deviate system operations from normal operating conditions.I.e., the system will cross the normal operational range. Alarm warnings at this stage are very useful in alerting 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 system will continue to deviate and reach to proven acceptance range(PAR) limits. At this point of operational limits, the system will generate critical alarms which the operators must take action as early as possible without leading to critical effects.
Example: In pharmaceutical or Biotech equipment such as stability chambers, refrigerators, incubators etc., alarms are used to indicate the abnormal temperature conditions which affects product quality or unsafe environmental conditions which threatens the safety of operators and equipment.
Challenges in manual alarm management in the Lifesciences Industries
Alarm management plays a very important role in assessing and managing the operational risks associated with Lifesciences production facilities. However, underperforming alarm management systems, inaccurate alarms, suppressed alarms can compromise your plant production and safety requirements.
- pharmaceutical and Biotech companies will find it difficult to perform manual alarm recording because of increased 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, alarms will be generated and when the operator ignores such alarm warnings and continue their production activities, a lot of issues will arise in the batch manufactured. Tracking these alarms manually is a very difficult task for the quality teams.
- A general manufacturing facility of Lifesciences industry will generate thousands of alarms per month. It is very frustrating for the plant operators to address these huge no of alarms effectively.
- It is very difficult to Categorize and prioritize alarms based on their effect on the product quality for an effective response to the issue within time.
- With manual alarms records, it is not possible to analyse batch-wise, equipment-wise, product wise or lot wise alarm data for extracting key insights which are useful of efficient alarm management.
- Many times operators are not been able to classify alarms which require a response and which does not require a response. This undifferentiated alarm signals will some times delay the response to critical alarms for abnormal situations affecting the product quality.
US FDA 483 observations on alarm management systems
In recent times USFDA has identified some shortcomings in their audit observations and issued warning letters to regarding alarm management systems which can impact the regulatory requirements. Few of them are
- Lack of data which can demonstrate the performance of alarm as expected in different environmental conditions.
- Lack of system for communicating alarms which occurred in after-hours or weekends to the employees.
- Alarms for out of temperature specification events are only audible only in the vicinity of the equipment.
US FDA 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 such as the condition which initiates the alarm and any interlocks that generates an alarm.
- Documenting the alarm parameters, i.e., alarm setpoints based on 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 in time without any delay.
AmpleLogic Alarm Management Software Features
- AmpleLogic Alarm 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 alarm management software has detailed log sheet which will offer you to capture information such as unit, block, equipment name, equipment code, batch no etc. along with the alarm details.
- Our alarm management software helps to Structure alarm records by including alarm type, priority, lot number and various other relevant details other than timestamp. This will help in sorting out alarm records very easily.
Documentation of alarm details
AmpleLogic alarm recording software helps you to document
- Alarm functionality
- The potential cause of alarm
- Alarm interlock details
- Setpoints or parameters or thresholds
- Escalation procedure and
- Finally able to document allowable response time as well.
- Data visualization based on customizable KPIs, transforming the huge and complex data into reports for better decision making.
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
- AmpleLogic Alarm Management Solution enables alarm tracking, alarm management, alarm documentation and to generate alarm reports at unit, plant and enterprise levels.
- Analyse data to get key insights about the functionality and performance of Critical and warning alarms in respective batches.
- Data analysis based on lot number is often performed in many pharmaceutical industries which helps to compare different lots. This will, in turn, generate batch-wise alarm reports and helps to identify the abnormal situations that occurred during batch
Equipment Wise Alarm Data
- Our alarm tracking software allows you to analyse equipment-wise alarm data to find out the performance, risks and deviations from specified parameters associated with each and every equipment in the plant.
- Generate alarm reports for data processing to find out interesting insights from alarm history which will help to enhance the systems in the process.