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Pacific Crossing has worked with several pharmaceutical, biotechnology and medical device companies in implementing and validating mission critical global enterprise solutions. Every successful project followed a common set of implementation and validation management practices that enabled our Clients to comply with FDA 21 CFR Part 11.
FDA Class I, II, and III
Pacific Crossing's team has extensive experience in developing and validating FDA class I, II, and III medical devices.
ERP Validation and Implementation
Pacific Crossing has experience in the implementation and validation of Enterprise Resource Planning systems. We have developed an out-of-the-box validation module and associated processes that integrate with leading ERP systems.
Patient Device Tracking Systems
Pacific Crossing has implemented and validated Patient Device Tracking systems for FDA Class I regulated implantable medical devices.
Drug Safety CRO's and Pharmaceuticals
Pacific Crossing has experience implementing and validating Global Drug Safety and Surveillance systems such as Relsys' Argus Safety for global Pharmaceutical companies and CRO's.
FDA 21 CFR Part 11
Pacific Crossing is experienced in FDA cGMP and ISO 9000 regulations and our consultants' expertise in this area enables our Clients to produce current, complete, documented FDA 21 CFR Part 11 compliant validation results.
Medical Positions:
