Audits & Regulatory Compliance for Booklet Labels & Medical Devices
At ATL, audits (internal and external) are taken very seriously, with involvement from all levels of our organization. Our pharmaceutical booklet labels must pass a rigorous "batch inspection process" performed by our Quality Assurance group. ATL's cGMP compliant Quality Management System has formalized Standard Operating Procedures in place. All complex medical device projects have formal, written control plans. Our machines and processes are validated to assure your product quality.
On-going quality is maintained through "Systems Validation Protocol." This includes IQ (Installation Qualification) of machines, OQ (Operational Qualification) of machines, and PQ (Performance Qualification) of machines and processes. We express our quality in six-sigma terms, or "defects per million." Employee training is constant as we keep ATL personnel "up to date" with all aspects of process improvement and external regulations.
ATL has successfully passed dozens of pharmaceutical and medical audits (21 CFR 210, 211, & 820) performed by teams from Novartis, Bristol-Myers Squibb, Schering-Plough, Abbott Laboratories, Pfizer, Johnson & Johnson, Eli Lilly, GE Medical, Intra-Med Diagnostics, PDC Healthcare, and many others.
ATL has also helped companies bring new medical devices to market by guiding them through (and completing) the various steps necessary in the FDA 510K process, as well as project management for new medical devices that require the CE mark in Europe. ATL has expertise in ISO-14971 Risk Management (for Medical Devices), ISO-11137 (parts 1 & 2) for sterilization, and MDD (Medical Device Directive) 93/42/EEC (for medical device export to Europe).