SoftwareCPR.com Annual Subscription
Let Alan Kusinitz and other SoftwareCPR experts keep you informed of new developments in FDA Software Regulation, enforcement actions, and related standards activities.
To see a list of some of the educational aides, validation and procedural examples on this site click Sample Educational Aides. A live clickable version is available to subscribers via their login.
To get additional information or to order send email to subscriptions@softwarecpr.com or click Catalog then select annual subscriptions - view products.
Benefits
Access to selected training material including visual aides, document and SOP examples and templates, Summary “Roadmaps” on selected topics such as Part 11, HIPAA, FDA recognized software standards and others.
Electronic reference manuals on 21 CFR Part 11, FDA Software Guidances and AAMI SW68, including checklists and hyperlinks to over 50 FDA guidances related to software and other topics and discounts on hard copy versions.
Searchable access to recent software warning letter and recall excerpts as well as all software excerpts in a convenient single pdf file format, a Part 11 only warning letter pdf, and a recalls pdf.
Email bulletins providing updates related to FDA software regulation.
A periodic email newsletter listing new items on the site and occassional analysis of selected items.
Priority response to technical and regulatory questions posted on the site (beyond 5/year as time permits).
Custom research reports listed in the catalog. (# free depends on subscription type).
Free loaners of selected FDA developed training videotapes and multimedia CD-ROMs subject to availability.
A free guided tour of this website and the FDA website using our web-based meeting room.
A subscription to premium content and services on the website provides high value at low cost to those interested in software safety, validation and FDA regulation.
Information on the site is updated and enhanced on a regular basis, newsletters are issued periodically, and email bulletins are sent for significant new developments.
Click Newsletter to see a recent example including a full index of available softwarecpr.com educational material.
Annual subscription options include single user ($250), 5 user ($350), site ($500), and company (or large division of a multinational corporation) users ($1000). Regardless of the option, training documents can be shared with others in your company.
Alan
Kusinitz
Managing Partner
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