Streamline and manage your activities, tasks and processes that normally require a lot of capacity and monitoring now with our pharmaceutical quality management solution. Our services range from technical installation, configuration, training, validation all the way to maintenance and support and have been key in numerous successful implementations in the pharmaceutical industry.
Pharmaceutical quality management
Iperion offers qualified MasterControl installation and configuration according to GAMP5. We help you validate the system and support you in the process of installation qualification, operational qualification as well as performance qualification. In response to the market, Iperion has developed a unique form building tool for MasterControl. Most of our customers have seen the advantage in using this extra service since it allows them to customize the system to their needs. Our MasterControl training for system administrators and end users also is a very helpful tool. Our after sales consists of long term support, upgrades and extra training if required. We can also offer Software as a Service for the MasterControl Suite on our GxP qualified data center (SAAS).
We help you to achieve excellence in quality management.
Quality process: CAPA
It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical: the automation of CAPA processes. When implemented properly, a Corrective Action (CAPA) software system improves product quality and safety, increases customer satisfaction, and more importantly, ensures FDA and ISO compliance.
Quality process: Change control
Quality Management Sytems (QMS) ensure change management processes in regulated environments and assure enhancement in productivity. In FDA-regulated and ISO-certified environments, companies are expected to establish procedures for effective change control software systems in order to ensure product quality and safety. Regulated and ISO companies are also expected to maintain detailed documentation on all changes that are made in a change control software.