With the increasing need to secure sensitive information, data integrity is here to stay. What questions do you have about 21 CFR Part 11? Read on to find the answers to commonly asked questions on this topic.
What is the trend in data integrity?
The trend is towards assuring the data security. Improved control over the Facility Monitoring System via a network in addition to strengthened data interpretation is becoming a central design focus. System architecture must evolve to protect against external tampering, a possibility even with the use of intranet. For example, one trend is the implementation of user-level login permissions that control the acquisition of data. Particle Measuring Systems products, especially those used in the Pharmaceutical market, are continuously evolving to meet these trends.
What has Particle Measuring Systems done to improve data integrity, as opposed to other companies?
Particle Measuring Systems has increased the risk mitigation of data acquisition and integrity, such as with the use of time stamps generated in the source sensors, and buffers at sensor and processor levels. To implement this approach while offering a reasonable price versus cost benefit to customers, Particle Measuring Systems developed its own processor in addition to storage and data management techniques. Mixing this approach with other commercial options would be expensive and impact reliability.
What is the trend in automation (related to FMS) in the pharmaceutical market ?
The trend is a move towards a virtual world (including virtual machines) to have the advantage of faster installation and ease of support in combination with a well known technology with common standards for all computer systems in a cleanroom.
When should PLC and Distributed Control Systems (DCS) be used?
The two “worlds” of PLC and DCS are converging due to the increasing power of industrial PCs. Typically, PLCs are used when a quick reply (in milliseconds) is required. DCS is best when the time to receive and manage data is not as critical, but where sophisticated management of large data quantities is required. The Particle Measuring Systems FacilityPro processor is closer in description to a DCS than a PLC.
What is the technical capability of an older PLC-based system and their compliance with 21 CFR Part 11 for data integrity related issues?
Using the industrial automation architecture, even if using the PLC approach, increases the reliability of the system. Particle Measuring Systems technology in combination with the industrial automation design of Supervisory Control And Data Acquisition (SCADA) results in an increased mitigation of risk.
What controllers are used in the FacilityPro®?
Particle Measuring Systems designed its own Programmable Logic Controller (PLC) with three FacilityPro processor models: 5010, 3000 and 1000. Please refer to the specification sheet for comparison between models.
Is it possible to maintain data integrity for an environmental monitoring system that is not automated?
An environmental monitoring system should be an automated system. The instruments should be connected to an automated system that runs the same sampling procedures every time and gathers the results from those instruments. The data gathered needs to meet 21 CFR Part 11, in that it tracks any changes to the system as well as any operator interactions. If you use a non-automated system, such as recording the values manually, there is the possibility of changes to data or sampling routines that might go untracked. Data integrity is not maintained in this circumstance.
Can the Particle Measuring Systems Environmental Monitoring System (EMS) be integrated into another general facility system (i.e., Siemens Building Management System (BMS))?
FacilityPro can communicate with third party systems such as Siemens or Allen Bradley PLCs. For example, they can be used to control the filling lines or Building Management Systems.
How do you create a daily report using the Particle Measuring Systems software?
Within the Particle Measuring Systems SCADA system there are specific tools to extract data from the database to create the reports. The reports can be set up based on the customer’s required parameters. For example, a parameter could be specifying a time frame related to the data extraction for particle counts in a cleanroom.
How can you increase the confidence level of the results?
As with any system, the greater the quantity of samples the better the confidence in the results. A continuous Environmental Monitoring System (EMS) will allow for greater confidence in comparison to only using portable systems taking periodic samples. To increase the confidence that the area being monitored is under control, a continuous monitoring system is recommended.
What is a typical audit trail review time frame?
It depends on the customer’s SOP. The production time and the audit trail review time frame should be the same time frame. All samples and actions should be monitored for compliance.
Are all flexible monitoring methods equally acceptable to the authorities?
Authorities do not indicate which architecture is preferred when applied to a monitoring system, but they do ask for users to be compliant with 21 CFR Part 11, to have disaster recovery procedure, to manage the data in the safest possible way, and to acquire the data in a secure fashion. All these goals are best achieved using industrial automation and Particle Measuring Systems technology.
Do you have more questions about data integrity, and how PMS products meet 21 CFR Part 11? Ask our experts here, and be sure to check out the following papers.