21 CFR Part 11 and Going Paperless

21 CFR Part 11 and Going Paperless

Welcome to our 21 CFR Part 11 questions and answers blog, where Particle Measuring Systems answers commonly asked questions about bringing your quality system into the 21st century.

For “original” versions, we have a hybrid system where we print reports (and audit trails) from computer systems. Is the paper version considered the original? We sign it.

The original raw data is composed of the data and information stored in the system that generates the report. In your case, the computerized system is the raw data source that generates the printout and therefore, the raw data contained in this system must be available for data accuracy control.

Is paperless data retention in microbiology achievable?

Absolutely. Modern computerized systems allow for tracking of the entire microbial sampling process, incubation, analysis and raw data retention.

How much data can be saved in the Lasair® III?

The Lasair III aerosol particle counter can store up to 3000 samples. The use of optional software such as DataAnalyst allows for unlimited, paperless sample storage.

If an administrator can delete data, what is the difference from that and an operator deleting the data?

At a higher level, there is always someone that has enough privileges to perform all file operations. It is important to note that, even at the server level, there is always an administrator that can potentially delete everything.

The scope of 21 CFR Part 11 is to provide guidelines and rules in order to mitigate that risk. Assuming operator mistakes may occur, the data deletion rights are normally restricted to administrator-only and the this function is protected by a required, dual-confirmation step.

Which information should be included in the backup? Should it be stored in a server, considering the possibility that the computer could be compromised?

It is recommended that backup data be stored outside of the local computer (for example, on a server machine).

The entire database of raw data and final reports should be stored and backed-up. You must ensure that the data you’re saving will be available for disaster recovery.

Cleanroom Particle Counter, Lasair, from Particle Measuring Systems

We have DataAnalyst version 2.0.1 and we use Lasair III 310C and Lasair III 5100. If we buy the new Lasair III 310C, will we receive a new version of DataAnalyst that works with our current counters?

DataAnalyst software will require the use of updated Lasair III Aerosol Particle Counter firmware. I recommend to contact your closest PMS representative and ask for our best commercial proposal for a new device and upgrade of existing fleet. Contact us for assistance.

Particle counters have a running buffer where data is overwritten. How is that compliant with data integrity? (3,000 data points, then first-in first-out)

Data integrity applies to all data generated by the instrument, from the initial, raw data stored in the instrument buffer to thermal or digital reports. At no point is this data editable (thus meeting data integrity requirements), and it is also transferable to allow for consistent use of the instrument’s fixed amount of internal storage.

In order to automatically store an unlimited amount of raw data and final reports from the instrument, I recommend the use of DataAnalyst software, which also generates human-readable reports in secure files.

How is the time for time-stamps coordinated for PMS systems?

The sample time-stamp in PMS systems is always controlled by the sensors. This guarantees that, even in case of communication issues between the sensor and the computer system, the time-stamp is always separately controlled by the particle counter

Download the full application note here for answers to more questions.

Have a question that wasn’t answered? Ask our experts…

Explore Other Topics

Search Knowledge Center: