Creating Robust Building Maintenance and Environmental Monitoring Systems for Your CGMP-Compliant Facility

by Faith Fraley, Director, CQV Engineering at Kymanox Every pharmaceutical manufacturing facility requires a controlled manufacturing environment. Temperature, humidity, and pressure are crucial to products and processes. Deviations can be disastrous, but environmental controls mean nothing if they aren’t properly qualified and validated. A programming issue with humidity controls could …

Building Tomorrow’s FDA/EMA Compliant Intelligent Enterprise Solution

by Brian Freymann, Director, Enterprise Solutions The core issue that drives compliant solutions is that drug, medical device, and instrumentation companies are monitored closely by the FDA/EMA. The regulatory requirements are designed for the purpose of managing all data that has an impact on patient safety. Both the FDA’s Title …

SAP / ERP – FDA Compliance

Quality by Design (QbD) & Patient Centricity Our overall approach to providing solutions is based upon the principles of Quality by Design (QbD) and patient centricity.  In addition to the standard ISO and ICH methodologies, we leverage practical life sciences experience, sincere advocacy for patient impact, expert planning, and sound …

Medical Device Design Controls

Developing a new medical device from concept to market can be a complex process. Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process (i.e., a system of checks and balances) for a medical device. Design controls make systematic assessment of …

Cleaning Validation

In 1988, Cholestyramine Resin USP finished drug product (a cholesterol medication) was recalled due to cross-contamination with low levels of an agricultural pesticide.  The contamination was a result of a lack of validated cleaning procedures and inadequate control of recovered solvent drums. This recall reinforced the need for validated cleaning …

Good Clinical Practice Compliance Solutions

Practical Hands-On Experience Kymanox has a diverse body of work, practice, and professional experience – exclusively focused on the life sciences. We understand your business in a way that translates into collaborative, cost-effective solutions. We provide: • Clinical Quality Management System Development and Optimization • Clinical Compliance Gap Assessments • …