Document Management Programs
Document Creation and Retention Requirements
Product History File
Creating Documents for Defense
The Danger of Not Retaining Documents
A Document Retention System
In the history of product liability litigation, documents have proven to be both helpful and harmful to plaintiffs and defendants. Unfortunately, one does not know whether what they are writing today will be helpful or harmful later. To curb that uncertainty, manufacturers can and should proactively establish document management systems that ensure compliance with FDA’s legal requirements and will result in creation of a story of the development of the product. The system must also include procedures that will minimize the creation of misleading and unnecessarily harmful documents.
Kenneth Ross is Of Counsel to the Minneapolis office of Bowman and Brooke LLP where he practices in the areas of product safety and liability prevention and advises manufacturers, product sellers and insurers on ways to identify, evaluate and minimize the risk of products liability and contractual liability. These guides do not constitute legal advice and are very general. You should consult competent legal counsel or Medmarc Loss Control before acting on any of the information in these guides.
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Medmarc is a part of ProAssurance Group, a family of specialty liability insurance companies. The product material is for informational purposes only. In the event any of the information presented conflicts with the terms and conditions of any policy of insurance offered from ProAssurance, its subsidiaries, and its affiliates, the terms and conditions of the actual policy will apply.
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