Lachman CONSULTANTS - Linda Evans O'Connor
编译：识林-椒
识林®www.shilinx.com版权所有，未经许可不得转载。如需使用请联系admin@shilinx.com
FDA Quality Metrics News
By Linda Evans O'Connor | November 16, 2015
On 11/11/15, at the ISPE Annual Meeting in Philadelphia, Russ Wesdyk from the FDA Office of Surveillance spoke about quality metrics. Since the FDA Metrics Guidance is still in draft and the comment period is still open, he didn’t provide any specifics about the Guidance itself. Since its issuance, industry has been studying and commenting on each and every aspect of the Guidance, there is little new to say there. However, the discussion wasn’t all “old news”.
Russ indicated that FDA is considering “testing the plumbing” with an aim to test the informatics capabilities of the program. According to Russ, companies will receive “no benefits from participating”; however, I disagree with that assessment. While there may be no direct benefits of participating wholly from FDA, the benefits that the company gains by participating will be huge. It will be a “no risk” way for companies to test their internal systems, and to test their own plumbing. I’ve heard a lot over the past year about the experiences that companies have had when participating in the ISPE pilot, from determining who supplies the data, determining where the data exists, harmonizing definitions, and to validating the data. These are all real hurdles. Even companies that considered themselves high on the maturity level have experienced challenges. These are companies that have been doing quality metrics for a while on an enterprise basis, have sophisticated data collection methods, and were confident in their data and abilities. If you are with a company that is just starting on the quality metrics journey, and may have only recently adapted the FDA draft metrics, your system may be untested. Participating in the program is a great risk-free way to test your system.
Russ assured the audience that while, in his opinion, there would be no advantages to participating, there would also be no disadvantages. FDA only wants the data so they can test their systems before going live. FDA is talking about doing this in Q2/Q3 2016. I highly recommend that companies consider participating. If you are interested, contact gundeep.ahluwalia@fda.hhs.gov.
