This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Our SoftwareCPR audit checklist for assessing conformance with the FDA Guidance for "Computerized Systems Used in Clinical Trials" can be viewed and downloaded at this link:  ClinicalTrialsSWFullChecklist. This checklist has been updated by Mary Decareau of SoftwareCPR to reflect...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. 21 CFR Part 11 is a topic of current focus for FDA and industry. In February 2003 FDA announced a major change in direction regarding Part 11 and withdrew all previous draft Part 11 guidance and the Part 11...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The pdf at the link provided is a reprint of an article entitled "Uses and Misuses of Probability in Medical Device Risk Management" authored by Alan Kusinitz, Managing Partner of SoftwareCPR, for the AAMI Biomedical Instrumentation and Technology journal...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. This reference manual includes the following documents in a single pdf with bookmarks and a clickable TOC. Be sure to click bookmarks in adobe so you can jump around the document easily. This pdf contains key FDA software guidances...Read More

This content is only available to Premium Level and higher subscribers.  See our Subscribe page for information on subscriptions. At a 1-day current regulatory topics session by ASQ held in Needham, MA, on June 16, 2005, Alan Kusinitz, Managing Partner of SoftwareCPR®, gave a presentation on the recent FDA Cybersecurity Guidance and the new revised FDA "Guidance...Read More

We hope you find this Regulatory Roadmap on HIPAA Privacy and Security useful.Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached document is a reprint of a chapter from an AABB book. The book is titled "Information Technology in Infusion Medicine".  The chapter is on 21 CFR Part 11 Electronic Records;Electronic Signatures and was authored by Alan Kusinitz,...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR has prepared an audit checklist for assessing compliance with 21 CFR Part 11 Electronic Records and Electronic Signatures regulation.  The checklist is intended for use by expert assessors knowledgeable in the regulation, its preamble, history, and current enforcement...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. At AAMI's International Standards Conference on March 11 2003 FDA's CDRH Software Compliance and Part 11 Representative (John Murray) gave the first presentation on FDA's changes in its approach to Part 11.  The slides from this presentation can be...Read More

This content is only available to Premium Level or higher subscribers.  See our Subscribe page for information on subscriptions. At AAMI's International Standards Conference on March 11 2003 FDA's CDRH Software Compliance Expert and AAMI Software Committee co-chair (John Murray) gave a presentation on FDA's software message and the role standards can play to benefit industry and...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The document at the link provided is a SoftwareCPR training aide on Part 11. It provides information and explanation of the Feb 2003 FDA redirection of its Part 11 regulation. It includes a summary of the areas of Part...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. A one page memory jogger for key sections of the Part 11 rule is at the link provided.  This is a SoftwareCPR training and auditing aide. This was updated Feb 2003 to highlight items for which FDA is changing...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR suggestions for a validation or Part 11 master plan are that it be a high-level plan not providing detailed document or protocol formats. Generally it is best if a master plan is a transient document.  It gets constructed...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The document at the link provided is a SoftwareCPR training aid that provides a partial template with some tips for construction of a handbook/procedure that addresses IT/Network issues regulatory compliance with 21 CFR Part 11 requirements and to support...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. 21 CFR Part 11 Electronic Records and Electronic Signatures is a short rule with a lengthy and informative preamble.  The attached training aid provides section of the rule side by side with relevant excerpts of the preamble with some...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached document is a SoftwareCPR training aid with commentary and explanation of 21 CFR Part 11 Electronic Records; Electronic Signatures by SoftwareCPR.  Note the date of this document as this is an evolving area. erecordsesigscommentary09012000-346Read More