Regulatory Open Forum

In a scenario that I am involved with, a DME (data medium exchange) file is used in conjunction with another software to allow customers to design a regulated class II part. We treat the DME file as a controlled document.  It is stored in a document and change control software system.

The DME gets revised from time to time and it needs to get pushed (uploaded) into customer systems so they have the most current version.  To do this upload, the DME needs to be exported from the document control system as a zipfile onto desktop of tech support employees; the zipflle is then uploaded through "ftp" into customer systems.

If number of customers is large, it would mean doing the update of the DME may take several days.  During these several days, the DME which is a controlled document will reside in more than 1 place; the document control system and desk tops of tech support employees.
Will this be acceptable to FDA and other regulatory entities?  What would be the best way to do this?

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------

This is a classic configuration management question. There are a number of ways to do this - including versioning, implementation dates, serialization etc. You'd be well served by reading some of the Configuration Management best practices books to pick one that works best for you. That said, so long as you document what you are doing and can identify the status at any given site at any given time, you should be able to convince FDA and other regulators that your controls are appropriate. The regulations are around "control" not some mystical ability to cut everything over at once.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Engineering
MN
------------------------------

Original Message:
Sent: 16-Nov-2017 21:32
From: Robert Nami
Subject: Updating software

In a scenario that I am involved with, a DME (data medium exchange) file is used in conjunction with another software to allow customers to design a regulated class II part. We treat the DME file as a controlled document.  It is stored in a document and change control software system.

The DME gets revised from time to time and it needs to get pushed (uploaded) into customer systems so they have the most current version.  To do this upload, the DME needs to be exported from the document control system as a zipfile onto desktop of tech support employees; the zipflle is then uploaded through "ftp" into customer systems.

If number of customers is large, it would mean doing the update of the DME may take several days.  During these several days, the DME which is a controlled document will reside in more than 1 place; the document control system and desk tops of tech support employees.
Will this be acceptable to FDA and other regulatory entities?  What would be the best way to do this?

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------

Thanks for your response Ginger.
The problem we have is exactly what you said:  "identify the status at any given site at any given time".
If you have a GoTo reference that you'd recommend off top of your head, please share title.
The couple books I briefly reviewed really didn't have a solution.

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------

Original Message:
Sent: 21-Nov-2017 09:32
From: Ginger Glaser
Subject: Updating software

This is a classic configuration management question. There are a number of ways to do this - including versioning, implementation dates, serialization etc. You'd be well served by reading some of the Configuration Management best practices books to pick one that works best for you. That said, so long as you document what you are doing and can identify the status at any given site at any given time, you should be able to convince FDA and other regulators that your controls are appropriate. The regulations are around "control" not some mystical ability to cut everything over at once.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Engineering
MN

Original Message:
Sent: 16-Nov-2017 21:32
From: Robert Nami
Subject: Updating software

In a scenario that I am involved with, a DME (data medium exchange) file is used in conjunction with another software to allow customers to design a regulated class II part. We treat the DME file as a controlled document.  It is stored in a document and change control software system.

The DME gets revised from time to time and it needs to get pushed (uploaded) into customer systems so they have the most current version.  To do this upload, the DME needs to be exported from the document control system as a zipfile onto desktop of tech support employees; the zipflle is then uploaded through "ftp" into customer systems.

If number of customers is large, it would mean doing the update of the DME may take several days.  During these several days, the DME which is a controlled document will reside in more than 1 place; the document control system and desk tops of tech support employees.
Will this be acceptable to FDA and other regulatory entities?  What would be the best way to do this?

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------

CMII for Business Process Infrastructure by Vincent Guess has a lot of the basics - but I am not sure if there is enough to answer your specific problem (its been a while since I read it). At our last company we actually hired a consultant to help us set up a system and train folks on the principles. I think he worked through something called the "Institute of Configuration Management."

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 28-Nov-2017 16:47
From: Robert Nami
Subject: Updating software

Thanks for your response Ginger.
The problem we have is exactly what you said:  "identify the status at any given site at any given time".
If you have a GoTo reference that you'd recommend off top of your head, please share title.
The couple books I briefly reviewed really didn't have a solution.

------------------------------
Robert Nami
Carlsbad CA
United States

Original Message:
Sent: 21-Nov-2017 09:32
From: Ginger Glaser
Subject: Updating software

This is a classic configuration management question. There are a number of ways to do this - including versioning, implementation dates, serialization etc. You'd be well served by reading some of the Configuration Management best practices books to pick one that works best for you. That said, so long as you document what you are doing and can identify the status at any given site at any given time, you should be able to convince FDA and other regulators that your controls are appropriate. The regulations are around "control" not some mystical ability to cut everything over at once.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Engineering
MN

Original Message:
Sent: 16-Nov-2017 21:32
From: Robert Nami
Subject: Updating software

In a scenario that I am involved with, a DME (data medium exchange) file is used in conjunction with another software to allow customers to design a regulated class II part. We treat the DME file as a controlled document.  It is stored in a document and change control software system.

The DME gets revised from time to time and it needs to get pushed (uploaded) into customer systems so they have the most current version.  To do this upload, the DME needs to be exported from the document control system as a zipfile onto desktop of tech support employees; the zipflle is then uploaded through "ftp" into customer systems.

If number of customers is large, it would mean doing the update of the DME may take several days.  During these several days, the DME which is a controlled document will reside in more than 1 place; the document control system and desk tops of tech support employees.
Will this be acceptable to FDA and other regulatory entities?  What would be the best way to do this?

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------