Those of us who have been in the trenches when it comes to making sure our documentation measures up to FDA standards know how nerve-wracking it can be to figure out what in the world the FDA wants!
Let’s face it, dealing with government regulations is a recipe for stress. The regs all seem endless with rules for the rules. We think it will be the end of the world if we can’t comply but we are paralyzed because we are afraid we will miss something.
Even the regulation seems menacing:
21 CFR 820.198 — Title 21 — Food and Drugs Chapter 1 — Food and Drug Administration Department of Health and Human Services Subchapter H — Medical Devices.
Whew!!! What a mouthful.
The thing is, all the FDA wants is what should be in any good customer support record:
- Name of device
- Date of complaint receipt
- Device identification and control numbers
- Name, address, and phone number of the complainant
- Nature and details of complaint
- Dates and results of the investigation
- Any corrective action taken
- Any reply to the complainant
So what’s the problem? The fear that one or more pieces of information will be missing and/or the documentation of the complaint, the investigation, or corrective action will not be to their liking.
The way to take some of the stress out of this is to make certain your complaint handling system or customer support solution has fields and rules configured to enforce compliance with each of these requirements.
Yeah, they can do that now. “They” being the companies that provide customer service and support software. Compared with what was available even 5 years ago in many companies, the capabilities of these solutions can be mind-blowing.
As in:
Where was this software when I was having to deal with the FDA?????
Even the regulations themselves are suddenly easy to read and understand.
With the surge in interest in Healthcare Record Keeping, it seems a good time to discuss some of the special handling that comes with regulatory compliance. I hope you will join in with your take on things as well.
Disclaimer: I don’t claim to be an expert. I can claim to have worked in a capacity where compliance to these regulations was mandatory and I know how it was handled then and at that company. I am hoping that some of you out there will share what you understand and the way you are currently handling things.