The Dietary Supplements industry is required to comply with 21 CFR Part 111 GMPs (Good Manufacturing Practices).  What is next?  Now that GMPs apply to the Dietary Supplement manufacturers, are there other rules that apply to their operations?  Well, if a Dietary Supplement manufacturer is electronically maintaining records required by 21 CFR Part 111, then 21 CFR Part 11 would apply and therefore require manufacturers to comply with Part 11.  Complying with one FDA regulation is a challenge from an interpretation and application perspective, but having to apply to more then one is even more of a task. Complying with 21 CFR Part 11 often requires Computer System Validation.  In addition to the interpretation and application challenges of the GMPs and Part 11, the Dietary Supplements industry is faced with finding the expertise to assist them with achieving compliance.  The best advice I can offer to my readers is to make sure you find experts that can help you identify the records you are required to maintain via 21 CFR Part 111, then identify what records are being maintained electronically.  These two steps are necessary to understanding and complying with 21 CFR Part 11, Electronic Records; Electronic Signatures.