Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The FDA’s approach to regulating electronic records has gone through more changes than the wardrobe of a temperamental starlet at the academy awards ceremony – and there are likely a few more changes to come in 2009.

We’re hearing that the rule may finally emerge in a “new, improved” way sometime this year. But a word of caution: If we had a dollar for every time the FDA missed an informal Part 11 deadline, we’d be able to buy a pretty nice lunch.

That said, a revitalized FDA does finally seem to be showing signs that it has its Part 11 revisions – and its related eMDR revisions – are indeed on track for unveiling sooner rather than later.

And while all indications are that the changes are likely to be relatively minor, they will probably be welcome ones.

For example, look for the FDA to drop most of its specific requirements for how companies should control or maintain electronic records. Also, while the FDA is not expected to spell this out, don’t expect them to change their current policy that they will not initiate an inspection based on Part 11. Instead, it is more like “seat belt” laws in most locations; you won’t be pulled over for not wearing one, but if you are pulled over for something else and aren’t wearing a seat belt, that will be added to the charges against you.

The FDA will also probably more clearly spell out that it does not expect validation of commercial software. I also wouldn’t be surprised if they back off some of their recommendations on changing passwords so often. Instead, they may call more for the creation of difficult-to-crack passwords (with numbers, capital letters, etc.), and less on the concept of changing an “easy” password every few weeks.

I do expect the FDA to get tougher vis-a-vis Part 11 when it comes to medical device and drug manufacturing done overseas for importation into this country. Bottom-line, watch for the FDA to clearly state that if there’s a problem anywhere along the line, the manufacturer will be blamed by the agency.

In March of 1997, FDA issued final Part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. That sounds pretty simple, right?

Unfortunately, the FDA’s then-approach was less of a helping hand and more of a chokehold on the medical device and drug industries.

We’re hearing that the agency knows it way overstepped itself then, and didn’t help much when it first unveiled the rule via guidance in February 2002. The agency was accused, with some grounds, that it was micro managing and stifling the very adoption of technology it wanted to advance.

The agency recovered somewhat in August 2003 when it relaxed its interpretations in what some then dubbed a “kinder, gentler” version of Part 11. In essence, the agency tried to shift away from telling drug and device companies how to achieve electronic record compliance and instead focus on what kind of results it was looking for in a good electronic record program.

Even that relaxation didn’t answer all the questions, but it was a good start.

Now we are waiting and hoping that the agency will address some of those in its next iteration of Part 11. At agency meetings, industry conferences, and in informal discussions with folks like me, agency officials seem to “get it” now and say they’re working to unveil a revised Part 11 that will make it easier for drug and device companies to harness the advantages of electronic records.

It’s been a long and winding road, but I’m still willing to believe if you are.

The best one stop shop for FDA Part 11 info can be found here: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm