GxP Compliance is not always one of the main priorities of manufacturers, which ironically often results in an over fulfillment of requirements, or at the very least halts processes. Many companies force themselves into a regulatory bind even though they could easily take an adaptive approach to specific risks, which would also provide more added-value.
What is needed is an analytical look at processes and their risk-balanced assessment – regardless of whether new requirements (MDR, ISO 13485, GxP in the Cloud, EU-GDPR) have to be met or existing GxP processes optimized. Most specifications provide leeway for own discretion and individual implementation.
Most specifications for GxP compliance provide leeway for discretion and customized implementation. With over 17 years of industry expertise and a wealth of experience, ARCONDIS is specialized in precisely this: Identifying processes and the applicable regulations, developing customized solutions for the resulting tasks and integrating them into existing processes. Always tailored to the company’s size, culture and risk strategy, which practically automatically yields the best possible result: maximum benefits with minimal effort.
ARCONDIS quickly and reliably gets to the heart of GxP Compliance for your company; it is not only a strategically-conceptual consultant, but also offers practical and applied support.
GxP Compliance – Convincing Facts
Interdisciplinary teams, 17 years of industry experience and an unfailing combination of competences speak for themselves. Still not sure? Simply contact us and see for yourself.