Are your quality systems in full compliance?We can help prevent & resolve issues you face
Quality Assurance & Compliance
At ATL, we understand how critical quality assurance and compliance are to you, which is why we focus on prevention and resolution through audits, training, and compliance management. Our hands-on support ensures that corrective and preventive actions are identified and performed quickly and efficiently.
FDA Compliance Issue Resolution
We collaborate with you to prepare effective responses to FDA forms and warning letters. In addition, we provide direction to ensure quality systems are in full compliance with the regulations. Our services include suggesting appropriate timelines, charting a course of action and proposing corrective actions
Compliance training is an essential tool for, and a basic expectation of, compliance. Our goal is to help generate and motivate new ways of thinking. We partner with you to develop effective and efficient compliance training programs, with customized training that covers the full range of quality systems initiatives.
Whether sessions are delivered via classroom instruction or a learning management system, our training goes beyond theoretical approaches and provides instruction that’s directly applicable to your business needs.
We help you focus not only on product quality, but also on the means to achieve it, in order to consistently produce high-end, accurate results. We generate validation and qualification protocols and reports to ensure the repeatability of specific processes, methods, and systems in order to meet predetermined acceptance criteria.
We can execute installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ) for you which involves verifying and documenting that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations and/or user requirements; perform as intended throughout the anticipated operating ranges; and perform effectively and reproducibly based on the approved process method and specifications.
Following all qualifications we provide a validation summary report documenting the validation completeness and system readiness to be used in a production environment. The report also documents any constraints or limitations placed on the production use of the system.