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Auditor Information

Auditor Information


Supplier Quality Audits

  
Nelson Laboratories understands that meeting quality requirements can sometimes be a handful. To make things a little easier, we have taken the following steps to ensure that your on-site audit is as painless as possible.
  • During your audit, you will have a qualified Nelson Laboratories regulatory auditor assisting you throughout your entire visit. They will be your main point of contact through every phase of the audit – from scheduling the audit, to completing any audit closure paperwork.
  • While performing your audit, you will be at ease in our Olympus conference room. The room has fully adjustable ergonomic seating, a 16-foot granite conference table, and a spectacular view of the Rocky Mountains.
  • The Olympus conference room is equipped with high-definition, large-screen computer monitors on which you will be able to view most of the documents that you will need throughout the day. No more carts full of paper-documents for you to squint at!
  • We also provide a gourmet catered lunch for each full day audit, which we will enjoy in the Olympus conference room with applicable study directors and management.  
These are just a few extra benefits of partnering with Nelson Laboratories, Inc.. If we can help take the hassle out of auditing, we will!
 
Scheduling a Quality Audit
 
If you would like to arrange an onsite audit or need assistance with a paper audit of Nelson Laboratories, please contact Julie Pizza (801) 290-7652 or Ryan Farr (801) 290-7644 to schedule your visit.
 
Please keep in mind that because Nelson Laboratories is a critical supplier to over 2,600 companies, there may be a 4-6 week lead time for scheduling on-site audits.
 
Audit Documents
 
As soon as you confirm an audit date with us, we will send you a link to a secure webpage with the following information for your advanced review:
  • Nelson Laboratories Quality Manual
  • Nelson Laboratories Organizational Chart (Top-Level)
  • Nelson Laboratories Employee List
  • Current FDA 482 or 483 as applicable
  • Current ACLASS (ISO 17025) Audit Summary of Findings
  • Master Procedure List*
  • Last Year’s External Audit Metrics
 You may also access the following documents below:
*SOP’s (internal guidance documents) may not be sent externally, but you may request a copy of any STP (test procedure) before, during, or after the audit.
 
** Please note: as of 17 Mar 2009, we are no longer ISO 9001 certified, but rather, ISO 17025. For more information, click here for a letter from our Director of Regulatory Affairs 
 
Dress Code:
Please remember that because we are a laboratory, close-toed shoes and long-pants are required.

Additional Information:
 
Please follow the below links for additional information
MN:BARRACUDA