Requirement for Electronic Records

[nwilliams]

Hi everyone, this is my first post! Hopefully I have put this in the right section and someone can help me.

I am in the process of performing the initial qualification of a pair of cryogenic freezers for storage of GMP materials. Both units feature controllers that will also log temperature data and system events such as door openings and alarms.

I am a little unsure of the requirements for electronic records in GMP-compliant systems, specifically whether if the equipment is qualified (in terms of temperature sensors calibrated against traceable standards and alarms qualified during OQ) whether an electronic record is still required?

If records are required then I am left with a problem in terms of qualifying data integrity.

Thanks in advance for any advice.

[DURGA PRASAD]

One thing is certain that if you qualify your equipment or Instruments or machines on any electronic versions of Record or record management systems you must have traceable and auditable readings, datas, changes, calibrations and Signatures of persons performimg these qualification or verification activities.

On the Calibration front: If an approved and correct method of calibration procedures is performed by using approved or standard calibration materials, such documents can be available in Physical or Electronic format, having all traceable standards, calibration procedure (SOP), Calibration data and Certificate of Status of calibation(Present status and Date of recalibration).

It is upto performers ability to use electronic records or not. Physical records along with traceability are also accepted in right formats.

But.. the future holds good for electronic record. You need to find a methodology or a suitable vendor to over come this problem.

[yodon]

Take a step back and ignore Part 11 (Electronic Records / Electronic Signatures) for a moment. What makes good sense? You have a system that collects data that confirms the equipment is operating in the required temperature range.

How do you know that data is accurate and cannot be 'adulterated' either intentionally or unintentionally? This is what you need to consider in validation.

Now, what records are required to run your business under cGMP? Are any of these records maintained electronically? If yes, then you need to manage them in accordance with the Electronic Records aspect of Part 11. Do your company or per regulation require these records to be signed? Then (presuming you sign them electronically) the Electronic Signatures aspect of Part 11 applies.

If you do have records / signatures that fall under Part 11, then you need to assess whether or not they are maintained in compliance. You may well need to add controls to ensure compliance. But first, define the system, see what's applicable, and then take any necessary actions.

[gtf]

Hi nwilliams,

2 assumptions:
1) your system is calibrated (documented)
2) we are talking about the raw data created during logging.

If you want to store these data electronically, you have to make sure and to prove, that the data are correct and integer.

Therefor you need some precautionary measures, like access restrictions to the data, may be you can sign them electronically (in form of a pdf ). Even in this case you still have to store the raw data, and so on...


Alternatively, if possible, you can print the raw data out and sign them manually.

Best Regards

gtf

[nwilliams]

Thank you all for your responses.

I understand the requirement for the records for the logging equipment during initial qualification; we will be using a Kaye Validator to generate temperature data at this stage.

The difficulty I am having is with the routine running of the freezers. While the controllers log the events and temperature data, separate software is required to download the stored data from the controllers. The software is not 21CFR Part 11 certified and outputs the data into a .csv file for viewing/printing via Microsoft Excel. This is obviously not secure as the data can be manipulated at this point and cannot be archived in any other way.

Using the controller was my preferred method prior to discovering the above, so we will probably use a chart recorder as it is easier to qualify and fits in with the systems in place for other temperature controlled environments on site.

Thanks all once again.

[gtf]

Hi, you also may use a hybride system, which means you download the data from the logger (validate the way you download the data) print the records out and sign the data manually.

Or you show and describe a way to store the raw data in a secure place where integrity and sfatey is ensured or both. May be can create a pdf and sign it electronically? There are varoius possibilities. Any questions, don`t hesitate...

BRgds

gtf

[siddhipharma]

This is a common requirement for the freezers / cold rooms or controlled temperature rooms. Routine monitoring of temperature with a periodic qualification / calibration of system. Yes you briefed correctly..during routine monitoring you need to maintain the records..there are so many arrangements in this setup can be adopted..
1. Auto logging of temperature records..on the moments shootup or out of range temp..alert / notification by system. data stored in secured environment. No manual inetrvention required for monitoring.
2. Using Auto system with manual intervention..daily monitoring for last day/ same day data..secured storage of data...manual sign on data verified / paper copy filing.
3. Auto system to log..with frequent monitoring of system with manual intervention ex. every 2 hous in a day recording...
4. In all cases data integrity is a must from regulatory agency point of view.....
5. Suggested approach is get some addon on your existing system which will auto convert the .csv into pdf..do the validation of system and utilized it. You may do initial phase with manual intervention..later switch over..