Systems Validation Services
HighPoint’s Pharmacovigilance Practice has extensive experience working in a highly regulated environment. We understand the need to produce documented evidence to prove your pharmacovigilance system and associated processes function appropriately, and we appreciate that this must be accomplished while adhering to project budget and timelines.
We offer up-to-date Validation Kits for Oracle Argus and Oracle AERS, and accelerators that can be used to assist in the validation of any pharmacovigilance solution. We will work with your existing Quality organization to develop and execute validation materials in compliance with your existing SOPs, or help you develop a comprehensive validation framework for adopting mission-critical systems in a regulated environment. We will also work with you post-implementation to ensure your system remains in a validated state through decommissioning.