Does anyone know of a public website that contains the various data retention rules specific to medical device manufacturing in Europe and in the U.S.? Does anyone know people who have e-discovery expertise with respect to medical devices that have complex customer data?

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Daniel,

The FDA recently updated their guidance document titled: Guidance for Industry - Medical Device Tracking; Guidance for Industry and FDA Staff. It contains many of the pertinent areas for Title 21. The 21cfrpart11 website should also provide some useful information.

With respect to legal discovery, you mention Europe and US. You should take caution to adhere to the European privacy rules for data that is not domiciled in the US, specifically as it relates to searching e-mails.

Also, another area that you have to pay attention to in regards to discovery is the Federal Rules of Civil Procedure (FRCP) which were amended last year specifically to update rules due to the consequences of technology and “electronic” information on discovery. I posted a FRCP “cheat sheet” that was written by the Director of the Federal Judicial Center on my blog page, you can download it here:

http://compliance.typepad.com/compliance/2007/03/judges_cheat_sh.html

For experts in the industry, there are many e-discovery firms; I work for an electronic archival, compliance and legal discovery enterprise software provider. We have expertise in providing the systems and technology that allow you to archive emails, instant messages, essentially all electronic records and deliver record retention rules for data management including destruction schedules, maintain data in a sound compliant architecture so that it can be proven to be authentic, contain an electronic chain of custody, etc. and embedded applications for supervising content and executing legal discoveries which allows you to accomplish your firms duty to preserve in the event of audit and litigation. Essentially, we help you to sleep at night.

However, for specific industry expertise you may want to look towards companies that perform “Systems Validation” for 21 CFR Part 11. In NJ CSSC Inc. is one that I’m aware of.

Good Luck,
Peter
December 2007

Links:

* http://www.fda.gov/cdrh/comp/guidance/169.html
* http://www.21cfrpart11.com/pages/library/index.htm
* http://compliance.typepad.com/compliance/2007/03/judges_cheat_sh.html