Medical Device Company

For a medical device company, RHO supported the implementation of a document/content management system.

The team was responsible for UAT testing, and quality reviews of SDLC validation deliverables. RHO developed documentation to support the rollout including: analysis of current process and recommendation for best practice-based future process, detailed data migration plan, and rollout plan. Technical and quality reviews were conducted to support standard operating procedures relating to: good testing practices, systems design specifications, document control, good documentation practices, IQ/OQ for application and/or database software and computer equipment and/or instrumentation, PQ/UAT for computerized systems, work instructions, backup/archive/restore, document control, record classification and retention, disaster recovery, coding standards, change control for hardware and software, validation of computer systems, vendor audit, inventory for host and network servers, deviations, methodology for computer systems, and information and asset protection.



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