2 Page brochure About the Company SoftwareCPR Approach
SoftwareCPR® specializes in software, regulatory, risk management, validation, and 21 CFR Part 11 consulting for medical device, pharmaceutical, and biologics manufacturers. We also provide full premarket submission and quality system training and consulting services.
SoftwareCPR® periodically provides internal Software Validation and Risk Management Training to FDA and Health Canada.
We provide strategic advice, regulatory risk management and negotiation, facilitation, , training, coaching, and hands-on assistance including in software validation.
Partners and Associates
Managing Partner:
Alan Kusinitz (click names for credentials sheets)
Partners* & Associates:
Stan Hamilton Sherman Eagles Mary Decareau
Lucille Ferus Sandy Hedberg Molly Ray
SoftwareCPR® Mission
To foster greater margins of safety, effectiveness, compliance, and profit through better software risk management, acquisition, development, validation, and maintenance.
*Note: Partner is a title describing a branding and marketing partnership and does not indicate ownership or corporate structure.
Copyright Ó 2010 Crisis Prevention and Recovery, LLC
