10 replies to this topic

[Yuni]

Hello everyone,

 

Happy holidays to all! As we are starting a new year I had thought about changing my HACCP paper records to computer files instead. Since every day I receive our drivers' reports for temperature during deliveries, the papers have been taking considerable amount of space in my drawers. But I was wondering if there is any regulation that prohibits keeping only scanned records and discarding paper records. 

 

Any comment will be greatly appreciated!

 

 

[kfromNE]

No there isn't. You can go completely electronic. Like with paper records, when an auditor is there, make sure records can be easily found.

[Ivy101]

I agree with KfromIA, paperless records is the trend now. So much easier to manage and can be accessed remotely.

[PegK]

Do you apply electronic signatures?   FDA was here for 3 days and voiced a negative view when we suggested going digital with our production records. 

Any thoughts, experiences or guidance on electronic signatures?  

[Gerard H.]

Dear Ange,

 

Good idea for 2019. Please, find some additional points of attention hereunder:

• Keep your records on paper from before the new storage method, as long as required, taking the best before date and the additional period required by your certification scheme into consideration
• Disk space - In some companies the storage capacity of data may be an issue, so be sure that you'll have enough storage space on your system
• Backups - Be sure that the files are backed up regularly
• Access - Be sure and verify that you have access to the scanned records, even in the case of a total breakdown of your system

Kind regards,

 

Gerard Heerkens

[Yuni]

Do you apply electronic signatures?   FDA was here for 3 days and voiced a negative view when we suggested going digital with our production records. 

Any thoughts, experiences or guidance on electronic signatures?  

 

Hello PegK,

 

Well actually since I have to sign and date these drivers' records after I receive them, I would scan them after being signed and dated by myself. So technically once they are scanned they would already have my signature written in pen. The reason I decided to do it this way is because I believe written signatures show more reliability than digital signatures that could be manipulated. As you may be aware it is recommended that electronic records are kept in a way that cannot be modified after the record is submitted, so in my case having the actual signature in pen as all the other information filled in my paper sheets just shows that the records were reviewed and signed right there and then...

[Yuni]

Dear Ange,

 

Good idea for 2019. Please, find some additional points of attention hereunder:

• Keep your records on paper from before the new storage method, as long as required, taking the best before date and the additional period required by your certification scheme into consideration
• Disk space - In some companies the storage capacity of data may be an issue, so be sure that you'll have enough storage space on your system
• Backups - Be sure that the files are backed up regularly
• Access - Be sure and verify that you have access to the scanned records, even in the case of a total breakdown of your system

Kind regards,

 

Gerard Heerkens

Hello Gerard,

 

Thank you, will definitely take these points in consideration. 

[kkaiser]

I actually made a video related to this topic.. Electronic Lab Notebooks are actually a really excellent tool! As long as you have the ability to tag what you need to and export the file, it's a great space saver and leaves less room for error! 

 

If you want to check out the video, here you go :) Good Luck! https://www.youtube....h?v=MabKwhkXcZw

[Fishlady]

If you are subject to US FDA documentation requirements that were in place before FSMA (such as seafood or juice HACCP or LACF), then your electronic records need to comply with 21 CFR 11.
If not, then you can keep them as original paper records or as true copies such as scans. As noted by others, be careful about backing up the records and ensuring that you can easily retrieve them if needed.

[CEA_safety]

This is a great topic. Many spreadsheets, whether it be in MS Office or Google Docs format, in order to be used and seen by the parties which require data to be entered and to be checked, are not secure from the standpoint of authenticity. They can be changed by users with a need for access. 

So, does this requirement mean that a company wishing to use paper records must buy document management system software? What advice can any experienced with electronic records management provide small companies without in-house IT departments?

 

Thanks

[Peak]

Scanning of documents is completely acceptable.  If you do not have a document control program to house your documents or spreadsheets I have seen companies "print them" and the sign and date them and the scan them as the latest record.  Then keeping a spreadsheet or database calling out the latest "version."  There are many ways to do this or to prevent electronic files from manipulation.

 

One very important thing to keep in mind when considering electronic filing is the integrity of your system.  It must be backed up and tested to insure that it can store the records consistently for the amount of time they need to be retained.   Failure to provide records due to system failure can be a huge issue.