Food
Compliance Services and Distribution Services. From its beginnings, ECL2’s core competencies have been centered in quality assurance. We have grown from that base, extending our knowledge, working with partners in the FDA-regulated industries to improve their operations.
Our Compliance Services cover the following areas:
Complete Quality System Development & Implementation
We will assist you in meeting the FDA’s Good Manufacturing Practices (cGMPs) 21 CFR Part 110 and help you to apply the American Institute of Baking Standards to your operation. If your operation is already up and running, we help you focus on the areas where you need the most assistance.
Auditing Services – Compliance Audits
Our auditing services will allow you to quickly identify where your or your supplier’s gaps exist, matching requirement to gap.
Validation, Commissioning & Qualification Services
ECL2 is the U.S. preferred provider for validation services for those seeking validation of their automated quality management system. Please click here for more on automated quality management systems. In addition to providing system validation and ensuring compliance with 21 CFR Part 11, we also provide complete process validation as well as commissioning and qualification services for your equipment. Please contact us with your specific needs.
Our Distribution Solutions: ECL2 can help you find the best distribution solution to meet your specific needs and if we can’t help, we will refer you onto someone that can. Either way, you can be assured that all distribution solutions have a comprehensive quality program to support them.
ECL2 worked with our general contractor, designing the manufacturing and warehousing space, worked with Sheri Gay, the President of Aero-Med Medical to establish operations and hire the right personnel, took care of our regulatory requirements, implemented a new quality system, trained personnel and even acted as a liaison with our current and prospective client-base as we expanded our operation. - Dan Del Mastro, Chief Executive Officer, Aero-Med Ltd.
