As I wrote in yesterday’s blog post, the FDA has some fairly stiff regulations about record keeping when it comes to customer complaints about products within the FDA’s interest:
- medical devices,
- food and preparation,
- animal and veterinary drugs,
- vaccines, blood and biologics,
- and radiation emitting products
The regulations have to do with the type of information that must be captured when a complaint is received by a company, including any investigation (or why one was not done), whether a MDR must be filed, any reply to the customer…
In short, you have to be able to provide documentation showing every action that was taken, as well as justification for why an action may not have been taken, from complaint receipt, through troubleshooting, investigation, customer interaction, etc., etc., etc, ad nauseum.
THEN you must be able to retrieve all of the information at the drop of a hat in the case of an audit or any other activity that requires this information. This isn’t as simple as it sounds.
Many companies have multiple systems containing only a part of the record. The customer support system may have the customer’s information and the initial complaint. Investigation documentation may be in yet another system used by R&D. Paperwork required for medical device reporting may be in hardcopy, filled out by hand, and filed in a box that eventually goes to off-site storage.
To make things worse, these information systems are not set up to retrieve the information in a manner required by the FDA. Complaints may need printing and handsorting. Files must be manually put together while hunting through information from other information systems. Many of the systems may have been home-grown for a specific need and now they are being forced to work in a way the designers never intended or expected.
The coup de gras when you can’t gather all the information requested, is that the FDA can, and will, levy a fine for not complying with regulations. And you are pegged for another audit that much sooner.
A single system designed to hold every type of information required by regulations and make it retrievable in any way needed. Everything is “under one roof” (and you did your backups, right?), all the information formats are compatible with each other, no printing and hand-sorting, no fretting because a piece of information held in another department has gone missing.
Then when the auditor comes calling, you can say, “No problem.”