Many manufactured products can have a significant impact on the well-being of consumers. As such, it stands to reason that stringent requirements and standards be set firmly in place for their manufacture.
The US Food and Drug Administration (FDA) has adopted a risk-based approach to establish and enforce regulations for pharmaceutical development, manufacturing, and quality assurance. Mandatory regulations (e.g., Current Good Manufacturing Practices or CGMP and 21 CFR Part 11), and voluntary frameworks, such as Process Analytical Technology (PAT), are defined to ensure final product quality through proper design, analysis, and control of manufacturing operations. To ensure product integrity and quality, it is mandatory to have consistent records of:
- Operations and procedures
- Process settings and variables
- Production events and conditions
- Quality and performance attributes of raw and in-process materials
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Traditionally, for batch operations, records were— wholly or in part—collected, managed, and represented manually.
The arrival of 21 CFR Part 11 and PAT brought a clearer regulatory roadmap (and framework) for transitioning to Electronic Batch Records (EBRs). There are many advantages to electronic record keeping:
- Improved regulatory compliance
- Improved accuracy, consistency, and repeatability
- Improved information accessibility and real-time analysis
The challenge now lies in negotiating the various issues related to infrastructure, existing systems, workflow, regulations, training, and the availability of a flexible solution to effectively, economically, and non-disruptively address these issues.
It is crucial to understand what constitutes a compliant electronic batch record system.
Also, it raises considerable questions: What level of electronic data capture is required? How is this data captured? How is it retrieved, analyzed, and reported? How is the integrity of data ensured? While these questions sound simple, their
While these questions sound simple, their non-trivial answers are critical to having the right solution in place.
An Electronic Records based solution with connection to the process via MOM software can completely change the complexity of the factory, not only from a compliance viewpoint, but also from a Continuous Improvement and real-time analysis viewpoint.
Utilizing Electronic Records
Based on a validated product manufacturing protocol, there are standard operating procedures or instructions in place that must be carefully followed. All exceptions/ alterations must be clearly noted and approved by authorized personnel.
For example, the instructions may require a detailed and step-by-step cleaning process that precedes the start of any batch operation.
TrakSYS™ provides the option to define the instruction steps (or to retrieve them from other sources), and then record the proper completion of each instruction step.
Types of Data Sources
The electronic record requires the inclusion of the designated information that must be recorded for each batch. Consistent, accurate, and secure data is a fundamental requirement of the batch record. Such data must include but is not limited to:
- Work order information
- Product information
- Production targets
- Operator information
- Environmental conditions
- Details of batch steps, stages, and phases
- Batch process variables
- Operator observations and comments
TrakSYS™ provides a comprehensive modeling and configuration engine that allows the user to define data sources, types, business rules, conditions, and workflow. The flexible configuration management and dynamic change control (keeping track of all modifications to
The flexible configuration management and dynamic change control (keeping track of all modifications to configuration, recorded data, notes, and electronic signatures), make it possible to meet the exact data management and reporting requirements of even the most complex and demanding batch applications.
As great as it is to have a comprehensive historical record of the environmental and batch process-specific variables, it is as important to have to-the-point, real-time notification of process anomalies and deviations from defined protocols.
TrakSYS™ makes it possible to alert the responsible personnel (as opposed to indiscriminate broadcasting of process alarms)— through their choice of delivery mechanism (e.g., email, page, SMS)—with specific messaging to expedite proper decision-making and corrective action in real-time. This has a profound impact on improved quality and productivity
To understand how to fully utilize EBR you can download for free the complete whitepaper right here.