Internal or external systems suppliers (IT Organizations) in the Life Sciences industry must be governed by SDLC-centered and Compliance-focused Quality Management Systems. According to GAMP5, the expected QMS should define:

    • The process being followed in order to deliver and support the system
    • Responsibilities, including clear separation of authority between Quality Assurance and other groups
    • Deliverables and Documentation
    • Planned reviews of the QMS and internal audits, as a part of continuous improvement of QMS and its use.

    The QMS should include formal procedures covering the activities that support systems and software development, systems release, change control, configuration management, data backup and restore, personnel qualification, documentation management, etc. The QMS components may be unique to the IT organization or shared with the predominant company-wide QMS.

    RCM offers its expertise in all aspects of IT-focused QMS and Quality Assurance, including, but not limited to:

    • Initial implementation of robust and harmonized QMS
    • Scalable “As-Needed” approach
    • QMS maintenance activities from periodic reviews to updates to ongoing training
    • QMS expansion due to organizational growth and changes
    • Periodic Audits/Assessments
    • Preparation and Training for Audits
    • Representation During Audits
    • Full Closure of Audit Findings
    • Etc. 

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