Topic Listing

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THESE ARE JUST SELECTED POPULAR ITEMS: Many more are available in the library section of the website.
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Topics  
Software Standards Navigator 
This topic provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards Navigator keeps you up to date on new standards activity and gives you expert insight into future changes to existing standards.
Draft standards are posted to allow subscribers to provide input to SoftwareCPR for the purpose of developing a position or comments on the draft. These draft standards will only be posted until the standards committee review process is complete.
 

NASA, Military, and UK Software Safety Standards 
This topic includes links to software safety guidance from other safety related industries that have useful information that could be applied to medical device software. All of these and sometimes others are in the document library section of the website. 

FDA Software Premarket Submissions 
This topic contains a number of FDA guidances and SoftwareCPR training aides related to preparation of software information in premarket submissions for FDA including 510(k)s, PMAs, and IDEs. 

Checklists 
This topic provides educational checklists related to several standards and regulations. SoftwareCPR checklists are available to paid subscribers of www.softwarecpr.com by using their login. These are only intended for use by those experienced in the related regulations and standards and are not intended to be used blindly as there may be significant interpretational ambiguities and evolving enforcement. Checklists issued by FDA itself that are included here are available to everyone as public information (without a login). Older or special topic checklists issued by FDA are available in the document library portion of this website. 

Selected Presentations 
This topic contains several of the slide sets for presentations posted on the website. These include ONLY SOME of the FDA staff presentations as well as SoftwareCPR presentations. Others are available in the library section of the website. 

21 CFR Part 11 Selected References 
This topic contains selected references for electronic records and signatures compliance. It is NOT an exhaustive set and MORE can be found by searching the document library on this website. Paid subscribers have access to all items listed while others have limited access. Other training aides may be provided to paid subscribers on request if they can not find what they are looking for on the site and if we have them available. 

Device Software SOP & Document Examples 
This topic contains selected partial document and procedure training templates as well as assorted validation tips. It is NOT an exhaustive set and MORE can be found by searching the document library on this website. Paid subscribers have access to all items listed while others have limited access. Other training aides may be provided to paid subscribers on request if they can not find what they are looking for on the site and if we have them available. 

MFG, QS & Design Tool Validation Training Examples 
This topic contains selected partial document and procedure training templates as well assorted validation tips for validation of manufacturing and quality system software. It is NOT an exhaustive set and MORE can be found by searching the document library on this website. Paid subscribers have access to all items listed while others have limited access. Other training aides may be provided to paid subscribers on request if they can not find what they are looking for on the site and if we have them available. 

Articles & White Paper Reprints 
This is a list of ONLY SOME of the most popular software related articles and white papers on our website; additional ones can be found be searching our library. All reprints not copyrighted by SoftwareCPR are provided with permissions of the authors or publishers unless they are government issued public information. Please respect the copyrights. The articles cover a wide range of subjects and we encourage submission of white papers or articles for posting. 

SCPR Policies, Procedures, and Admin Instructions 
This topic contains a list of business policies, instructions, and procedures for members/partners of SoftwareCPR only. All Partners are expected to conform with any item posted here that is labeled a policy or procedure. Access to post items here is restricted to the Managing Partner and as such all items posted have the approval of the Managing Partner at the time of posting. SoftwareCPR partners may propose additional items to be posted at any time by emailing them to the Managing Partner. 

Temporary - no access 
Private project access for temporary transfer of information.