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GMPs make it perfectly clear: All working parts of any medical device must be verified and validated. Period.
But how this requirement applies to software components is still a little sketchy.
Don't take the chance of being hit with a 483 or warning letter.
Use this new compliance kit to develop a solid risk-based software validation plan that will pass any FDA inspection.
The FDA is cracking down on companies that don't carry out device software verification and validation, issuing an increasing number of 483s and warning letters to 1) manufacturers of medical devices with embedded software, and 2) manufacturers of software used as a device itself.
With this new compliance kit, you'll find out exactly what FDA inspectors are being trained to look for in terms of device software verification and validation. And you'll learn how:
And then you'll learn to set up an 11-step plan for device software validation and verification, including how to:
You'll also find out what the FDA accepts as an appropriate documentation model … its expectation for your testing software, ERP software and more … and, when and how to use design qualification, installation qualification, operational qualification and performance qualification.
What will you find in The FDAnews Medical Device Software Validation and Verification Compliance Kit? An invaluable collection of consolidated material from the FDAnews training database, designed to help your company become fully compliant as quickly as possible. For one low price, you get:
Let's face it. Mastering software validation and verification is a time-consuming task. And it's frustrating when an employee you’ve trained leaves you to go to work for a competitor — and you have to start all over again.
But with The FDAnews Medical Device Software Validation and Verification Compliance Kit, you can train anyone who needs it now right in your own offices and keep everyone up to date as staffing changes occur for one low price.
Need Extra Copies?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Simply choose the quantity you wish to order the discount will be calculated automatically.
3-4 copies – 10%
5-6 copies – 15%
7-9 copies – 20%
10+ copies – 25%
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