The Challenge Of Managing Regulatory Submissions & Correspondence
Life science organizations produce large volumes of documents necessary for submitting applications to regulatory agencies. They need to have records of those documents as well as all related communications from sites around the world. This creates a situation that can be rather daunting.
Sponsors must first make sure all documents are going through the proper review and approval cycle and that controls are in place to meet regulatory requirements such as 21 CFR part 11. Once the documents are published and ready for submission to the regulatory agency, they are typically stored on a file share. Although that file share has access controls in place, it will not have granular-level access controls.
WHITE PAPERS & CASE STUDIES
Meeting Accuracy And Safety Objectives With Inspection And Weighing Technologies
New approaches to selecting and using inspection and weighing equipment can help pharmaceutical processors better meet accuracy and safety objectives.
The Cost Of A Powder Stoppage
Operations managers cope with powder jams on a recurring basis. At least once a month, there may be a more significant event that brings production to a halt and seriously affects output for that day.
IMD-W™ Microbial Challenge Test Results
This fact sheet provides a summary of microbial test results obtained with the IMD-WTM-series instantaneous microbial detection™ system for water.
Exceeding GMP Of Medical Devices At Each Step In The Production Continuum
Through years, ATL has emerged as a leader in the manufacture of disposable medical devices. ATL is an FDA-registered medical device company whose custom disposable medical components are manufactured and shipped worldwide.
Pharmaceutical Company Cuts Packaging Costs
In tough economic times, First Priority, manufacturer of generic veterinary pharmaceutical products, decided it was time to take a hard look at where they could cut costs without compromising on efficiencies and quality of their products.
Be In Control Of Product Quality – Do Not Just Rely, But Understand
Past experiences have shown that too often product quality is based on sole reliance of vendor certifications, statements and promises. To diminish such reliance new technologies started to be implemented, like process analytical technologies (PAT), process controls, automation etc. often once again overexerted as the solution to all problems. Activities that supposedly result in higher product quality due to better process controls. Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing LLC