Services offered by MPECT

• UDI, MDSAP, Track & Trace, MDR – Alignment with FDA and key industry associations on policies & procedures Our expert resources with direct, hands-on industry experience in supply chain, IT, compliance / quality, R&D, and related programs. Deep experience in track and trace, product configuration management, and surveillance in devices and biotech/pharma
• Cloud, Web, Virtual Server and Infrastructure Compliance – MPECT Life Sciences Cloud team specializes Life science companies need to consider data security, data migration, and data integrity, while ensuring that infrastructure vendors provide necessary functionality to meet compliance regulations around the world.
• GRC and Quality Software – Full design and implementation capabilities to provide strategic guidance and support for program assessment, strategy, design, and implementation. A comprehensive Governance, Risk, & Compliance (GRC) program can save you time and money by unifying your approach to designing and implementing effective controls and risk mitigation tactics, and can provide a competitive advantage by freeing your organization to move more quickly and focus more resources on achieving business goals.
• CAPA Process & 483 Remediation – Remediation actions are defined where necessary and implemented after evaluation of the risk associated with the MPECT Control Gaps identified. Based on the results of the Initial Risk Assessment and for each of the asset of the organization entity, all GRC controls are identified and implementation assessed and tested.