SQA llc
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Expert Consulting for Your Business Growth

Expert Consulting for Your Business GrowthExpert Consulting for Your Business GrowthExpert Consulting for Your Business Growth

Transform your strategies with our expert consulting services.

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(817) 239-7513

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About SQA Consulting

Our Mission


At SQA llc, our mission is to protect Sports and Active Nutrition brands through: 

  • regulatory compliance consulting
  •  supplier qualification and monitoring
  • Internal/GAP audits 
  • On-site or remote Internal Auditor Training Classes


Regulatory Compliance Consulting can be tailored to investigate specific areas of a brand owner's business:

  • Assistance in responding to 483s/warning letters
  • Crisis Management/Business Continuity plans & exercises
  • Food Safety Plans and Food Defense Plans
  • HACCP plans
  • SOP/SSOP development/Document Review
  • Label Review (verification/substantiation of label claims)
  • DQ/IQ/OQ/PQ


Supplier Audits

 can be tailored to investigate specific areas of a supplier's business:

         Supplier Qualification audit:   

  • An initial assessment which is conducted for a new supplier to confirm its legitimacy and basic capabilities, helping to comply with regulations.    
  • Verifies the supplier's adherence to legal standards, regulations (e.g., FDA requirements), ethical guidelines, and contractual obligations.


         System Monitoring audit: 

  • Periodic evaluation of the supplier's quality management system (QMS), such as cGMP, SQF, ISO 22000, and ISO 9001, to ensure its continuing compliance and reliability.


         "For Cause" audit:  

  • Targeted investigations due to a trend in nonconformances, customer complaints, product Out Of Specification (OOS), or product recall.


Internal/GAP Audit

Internal and/or GAP audits can be performed at specified intervals, either on-site or remotely.


Internal Auditor and/or cGMP Training Classes

Classes can be either on-site or remote.


We aim to provide tailored solutions that drive efficiency and growth in every project we undertake.

Free Template Downloads

Quality Agreement TEMPLATE (DOC)Download
QAF-012 Supplier Qualification Questionairre 20170807 (docx)Download
SOP Q009.00 Supplier Approval Procedure.docx (pdf)Download

Frequently Asked Questions

Please reach us at David@SQA-Verify.com if you cannot find an answer to your question.

At SQA LLC, we offer a wide range of consulting services including

  • Regulatory Compliance Consulting,
  • Document Preparation, 
  • Supplier Qualification & Monitoring, 
  • Internal and/or GAP audits, 
  • On-Site or remote Basic cGMP up to Internal Auditor training classes.

The duration of a consulting project varies depending on the scope and complexity of the project. We will work with you to determine a timeline that meets your needs.

Supplier monitoring audits can take 1 day for simple agendas to 2 days in cases of a For-Cause audit.

We have experience working with clients in various industries, including Dietary Supplements, Functional Foods, Private Label, Contract Manufacturers, Holding Warehouses, Distributors, Ingredient, Component and Service Suppliers, Laboratories, Medicated Animal Feed, Pet Treats, x-ray inspection, Lyophilization, 

Plastic Injection Molding and Urethane Extrusion.

For use with regulated activities, ChatGPT, OpenAI and the like is not compliant with 21 CFR Part 11 "out-of-the-box" because the standard versions do not meet the strict requirements for data security, validation, and control.  Any organization that uses ChatGPT, OpenAI, Scribe and the like must implement its own rigorous controls and validation processes to meet FDA regulations.


While these options are indeed powerful, the regulations do not release you from the responsibility to have the system overseen by a qualified person, usually a Process Controls Qualified Individual (PCQI).


Custom or enterprise versions, typically with and associated Business Associate Agreement (BAA), can be used to build a compliant solution for specific workflows.


Key Challenges for Standard ChatGPT

  • Date privacy and security: 

               Standard ChatGPT logs and stores every conversation, including any confidential or 

               sensitive data users input.  The information can then be used to train future AI 

               models.  This makes it unsuitable for handling electronic records in FDA- 

               regulated activities.


  • Lack of system validation:

              Part 11 requires that any software used for electronic records be properly validated   

              to ensure accuracy, reliability, and consistent performance.  The standard version of 

              ChatGPT is not developed for this purpose, and a user organization cannot perform 

              the necessary validation.


  • Inadequate access controls and audit trails:

               Commercial versions of ChatGPT lack the robust, computer-generated audit trails 

               and specific access controls required by Part 11 to track changes and limit access to 

               authorized personnel.


  • No electronic signature:

               Part 11 specifies strict controls for using electronic signatures, including unique IDs 

               and passwords, that do not exist in the consumer version of ChatGPT.


  • Absence of a BAA:

              OpenAI does not automatically sign a Business Associate Agreement (BAA) with 

              standard users.  A BAA is a legal agreement required under HIPPA (and aligned with 

              Part 11 goals) to ensure a third-party vendor handling protected health information 

              (PHI) implements required safeguards.


Path to a Compliant Solution

For organizations in regulated industries, creating a compliant solution requires a customized approach that isolates the AI model within a secured, validated environment.  Steps include:

  • Enterprise-level or custom API:

               Use OpenAI's Enterprise solution or API with BAA. which allows the organization to 

               control the security and validation process.


  • Secure infrastructure:

               Deploy the AI within a secure, controlled environment, such as a private cloud, that 

               implements strict access controls and encryption.                


  • Validation and documentation:

               Formally validate and document the entire system, including all workflows, data 

               processing, and security measures, to ensure it performs as intended.  This will 

               generally be performed by a PCQI.


  • Data sanitization:

               Implement processes to de-identify any confidential data before it is sent to the AI, 

               further reducing he risk of a breach.


  • Human oversight:

               Require a human reviewer (PCQI) to verify and/or validate all AI-generated content 

               before it is used in any formulation context.


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