Evernote seems to be a powerful, extensible cloud based application. I am curious if anyone in the group uses it in their lab and how do they use it, for what purpose and how well does it work for your needs?/”
My reply to this was:
I’d not advise it. Besides a vendor audit to ensure availability of the system and backups you’d need to ensure Evernote data cannot be obscured or changed, make sure time, date and user stamps are in place and the data integrity is maintained for the duration of the retention period.
While larger companies nowadays use validated systems such as Trackwise, SAP modules and the like for following-up on their CCPs, deviations, CAPAs etc., in GMP inspections of smaller companies I usually encounter some sort of electronic Access- or Excel-based lists that are used (typically by QA) for this purpose, i.e. entering cases, assigning event ID’s, and supervising the progress of investigations / implementation measures until approval / close-out.
These lists a quite critical, especially when many events have to be dealt with, a.o. because of the risk that certain events might get ‘forgotten’.
Nevertheless, I see quite often that little is done to ensure that entries in these lists are correct and uptodate. Another issue is controlled handling of hardcopies of these lists which often, not astonishingly, are outdated as soon as they come out of the printer.
Any ideas what it makes challenging to deal with these lists? What are proven good practices worthwhile to share?”
My reply to this was:
Just like for word, Excel has a revision tracking feature.
There are ways to log changes to tables data in Access, but none are particularly robust.
It all boils down to using the right tool for the job. Is Excel or Access a suitably regulatory compliant solution or do you need to use something else?
The last line of the my comment sums things up nicely.
Having worked in the pharmaceutical industry where I’ve dealt with electronic systems, paper based systems, programmed my own access databases and Excel spreadsheet and been on projects such as LIMS system validation, I figured I’d make notes on the FDA’s 2016 guidance for industry document regarding Data Integrity and Compliance With CGMP. This draft is for currently open for comment and the guidance addresses data integrity in:
- drug manufacture
- finished pharmaceuticals
- positron emission tomography drugs
My reply to a post on LinkedIn.
“When choosing Cloud vs on-premises, we need to be reminded that a “no decision” is a decision and the risk should be assessed. ”
A good reference for such data’s retention is the FDA’s Guidance for Industry 21 CFR Part 11; Electronic Records;Electronic Signatures; Maintenance of Electronic Records.
The Question posed on LinkedIn.
“Companies are expected to perform trending of their monitoring data. Detecting adverse trends should help to prevent exceedings of regulatory limits, as defined e.g. in Annex 1 to the EU or PIC/S GMP Guide for aseptic operations.
As you all know, microbial counts do not follow a normal Gaussian but a logarithmic distribution, such that the classical way of calculating and defining thresholds for alert (often +/- 2s) and action (+/- 3s) cannot be applied.
Hence, what alternative approaches to setting alert and action limits for microbio monitoring data (environment, staff, water, …) do you apply?”
You need to have defined what your alert and action levels are and how many times in a row a site can be in alert before this constitutes an action. You also need to define how many below alert results may indicate an adverse trend.
Basically you want to get what is heading out of control under control.
You need to have a defined trending and reporting period and reports need to be signed off both by the microbiologist and QA manager.
Your internal process and documents will be dependant on which regulatory bodies have oversight at your facility.
The FDA, PDA, PIC(S), ICH and good resources like the PMF are valuable when developing your internal processes.