Hi Patricia
The appropriate tools are going to depend on how many standards you're using for how many different types of products. Some basic things that could help at any size...
A spreadsheet or database to track where each standard is used, so you know where to direct the gap assessments when there are changes - by document and/or by product family.
A documented procedure in your quality system defining who is responsible for being aware of standard updates, doing gap assessments, and planning remediations, with defined timing expectations. Creating records as evidence the procedure is being followed.
Formally or informally defining the standards that are most critical to the business and monitoring closely not only final publications but also the standard development process. And potentially even being part of the committee.
Also monitoring for any new standards that may become applicable.
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Anne LeBlanc
United States
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Original Message:
Sent: 10-Jan-2023 14:45
From: Patricia Loritz
Subject: Standard management tools
Looking to revamp our standard management in house.
Anyone have any great ideas that you use for what best practices to trace to current conformity product requirements for FDA and EU?
Gap assessments?
Thanks!