A QMS system is a regulatory requirement that FDA/global regulatory inspectors and ISO auditors consider critical. Lumino Advisors can support development, oversight and compliance auditing of your ISO, GLP, GMP quality systems and procedures.
A QMS system 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 Advisors 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 Advisors can perform internal and supplier compliance audits for Good Manufacturing Practice (GMP) and Good Laboratory (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 Advisors, we know that unexpected results can arise in any organization, and that determining root cause quickly is essential in minimizing any potential risk. At Lumino 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.