LeanWays

“They did not know it was impossible so they did it.” – Mark Twain

LeanWays

“They did not know it was impossible so they did it.” – Mark Twain

Quality / Safety / Process Audits & Compliance

An audit is an evaluation of an organization, system, process, project or product.

For which industries can it be useful?

We can perform audits in most industries and sectors.
We are specialized in the pharma and biotech industries (in Manufacturing, Quality Assurance & Control, Engineering, Process, Logistics, Supply Chain, Environmental, Health & Safety (EHS)).

    Pharma and biotech industries

    We help your business:

    • Ensure compliance with US Food and Drug
      Administration (FDA) and with EMEA Health
      Authorities.

    By:

    • Performing audits of your company’s Quality
      Management System.
    • Supporting you during pre-approval inspections from
      the FDA / EU Health Authorities.
    • Accompanying you in the Enhancement of a Change
      Control culture.
    • Ensuring cGMP compliance of your Contract
      Manufacturing Organization (CMO).

    Product based companies

    We help your business by:

    • Performing safety audits of your processes
      (Certified Safety Advisor level III).
    • Executing Hazard and Operability Studies (HAZOP) & Action
      Plans. See our Risk Assessments section.
    • Performing Process and Equipment audits, also
      in view of merger & acquisitions.