A Quality Management System (QMS) is a regulatory requirement that FDA/global regulatory inspectors and ISO auditors consider critical. Lumino can support development, oversight, and compliance auditing of your ISO, GLP, and GMP quality systems and procedures.
A QMS is a regulatory requirement considered critical by FDA, ISO, and other global regulatory examiners. With your organizational structure/size and stage of development in mind, Lumino can help you develop, optimize, and oversee your ISO, GLP, GCP, and GMP quality systems. We can help develop necessary procedures and policies that meet both industry best practices and regulatory expectations.
We know that a key element of ensuring that systems and processes are in control, and that quality is built into the product, is conducting a rigorous, on-site audit. The experts at Lumino can perform internal and supplier compliance audits for Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) systems as well as nonclinical study phase audits. We review processes, procedures, systems, data, and facilities to ensure that your systems and those of your suppliers will meet current regulatory expectations and standards. Additionally, we remain committed to working with you and your key suppliers to remediate any findings.
At Lumino, we know that unexpected results can arise in any organization, and that determining root cause quickly is essential in minimizing any potential risk. We have extensive experience at conducting thorough and timely investigations and can help you to resolve issues – no matter if they are simple or complex. We can also help your organization implement changes to correct and prevent future deviations and unexpected outcomes.
To keep an operation efficient and effective, routine Quality compliance work is required. We can support that work for you on an on-going basis or during peak periods. This work may include, but is not limited to, activities such as batch record review/release, label review, and KPI analysis.