Regulatory Open Forum

Hello,

I have a question regarding CFR part 11 compliance for medical device manufacturer and Quickbooks (Fishbowl) inventory system.  We have a hybrid system and use Fishbowl as our active inventory system.  Our long term storage has been to print lots and store the hardcopies.  I'm not so sure this meets CFR part 11 compliance.  I'm thinking we need to first validate the program, ensure regular system backups, then have a qualified individual verify (sign and date) our printed copies prior to long term storage.  

What do you think?  The FDA guidance doc doesn't offer much.

Thank you

Hello,

I have a question regarding CFR part 11 compliance for medical device manufacturer and Quickbooks (Fishbowl) inventory system.  We have a hybrid system and use Fishbowl as our active inventory system.  Our long term storage has been to print lots and store the hardcopies.  I'm not so sure this meets CFR part 11 compliance.  I'm thinking we need to first validate the program, ensure regular system backups, then have a qualified individual verify (sign and date) our printed copies prior to long term storage.  

What do you think?  The FDA guidance doc doesn't offer much.

Thank you

Hello,

I have a question regarding CFR part 11 compliance for medical device manufacturer and Quickbooks (Fishbowl) inventory system.  We have a hybrid system and use Fishbowl as our active inventory system.  Our long term storage has been to print lots and store the hardcopies.  I'm not so sure this meets CFR part 11 compliance.  I'm thinking we need to first validate the program, ensure regular system backups, then have a qualified individual verify (sign and date) our printed copies prior to long term storage.  

What do you think?  The FDA guidance doc doesn't offer much.

Thank you

Hello,

Thank you for your reply.  We actively use the electronic system and print/store hardcopies as our long term archiving solution for old lots.  If FDA were to come in 10 -15 years from now (device lifetime), or we needed to recall old lots, I'm not so sure we would be able to access our 2014 QuickBooks data.  We are printing and storing old lots in case that were to happen.  I don't want to create extra work, but I'm not sure how else to handle this as we are currently bound to a hybrid system.  Any additional advice is greatly appreciated.

Hello,

I have a question regarding CFR part 11 compliance for medical device manufacturer and Quickbooks (Fishbowl) inventory system.  We have a hybrid system and use Fishbowl as our active inventory system.  Our long term storage has been to print lots and store the hardcopies.  I'm not so sure this meets CFR part 11 compliance.  I'm thinking we need to first validate the program, ensure regular system backups, then have a qualified individual verify (sign and date) our printed copies prior to long term storage.  

What do you think?  The FDA guidance doc doesn't offer much.

Thank you

For device manufacturers, I have a little different cut on the problem.

There are really two issues to consider: data integrity and record retention. I'm assuming you are doing records, but not electronic signatures.

For the most part, Investigators focus on software validation in 820.70(i), rather than Part 11. If you have all of those validations in place, you should be fine.

For records, you need to retrieve them for the required record retention period. Remember that different parts (803, 806, 820, etc.) have different requirements.

Hello,

Thank you for your reply.  We actively use the electronic system and print/store hardcopies as our long term archiving solution for old lots.  If FDA were to come in 10 -15 years from now (device lifetime), or we needed to recall old lots, I'm not so sure we would be able to access our 2014 QuickBooks data.  We are printing and storing old lots in case that were to happen.  I don't want to create extra work, but I'm not sure how else to handle this as we are currently bound to a hybrid system.  Any additional advice is greatly appreciated.

Hello,

I have a question regarding CFR part 11 compliance for medical device manufacturer and Quickbooks (Fishbowl) inventory system.  We have a hybrid system and use Fishbowl as our active inventory system.  Our long term storage has been to print lots and store the hardcopies.  I'm not so sure this meets CFR part 11 compliance.  I'm thinking we need to first validate the program, ensure regular system backups, then have a qualified individual verify (sign and date) our printed copies prior to long term storage.  

What do you think?  The FDA guidance doc doesn't offer much.

Thank you

Hello,

Thank you for your reply.  We actively use the electronic system and print/store hardcopies as our long term archiving solution for old lots.  If FDA were to come in 10 -15 years from now (device lifetime), or we needed to recall old lots, I'm not so sure we would be able to access our 2014 QuickBooks data.  We are printing and storing old lots in case that were to happen.  I don't want to create extra work, but I'm not sure how else to handle this as we are currently bound to a hybrid system.  Any additional advice is greatly appreciated.

Hello,

I have a question regarding CFR part 11 compliance for medical device manufacturer and Quickbooks (Fishbowl) inventory system.  We have a hybrid system and use Fishbowl as our active inventory system.  Our long term storage has been to print lots and store the hardcopies.  I'm not so sure this meets CFR part 11 compliance.  I'm thinking we need to first validate the program, ensure regular system backups, then have a qualified individual verify (sign and date) our printed copies prior to long term storage.  

What do you think?  The FDA guidance doc doesn't offer much.

Thank you

Hello,

Thank you for your reply.  We actively use the electronic system and print/store hardcopies as our long term archiving solution for old lots.  If FDA were to come in 10 -15 years from now (device lifetime), or we needed to recall old lots, I'm not so sure we would be able to access our 2014 QuickBooks data.  We are printing and storing old lots in case that were to happen.  I don't want to create extra work, but I'm not sure how else to handle this as we are currently bound to a hybrid system.  Any additional advice is greatly appreciated.

Hello,

I have a question regarding CFR part 11 compliance for medical device manufacturer and Quickbooks (Fishbowl) inventory system.  We have a hybrid system and use Fishbowl as our active inventory system.  Our long term storage has been to print lots and store the hardcopies.  I'm not so sure this meets CFR part 11 compliance.  I'm thinking we need to first validate the program, ensure regular system backups, then have a qualified individual verify (sign and date) our printed copies prior to long term storage.  

What do you think?  The FDA guidance doc doesn't offer much.

Thank you