Make compliance a competitive-edge
rather than a productivity drag

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AUDIT SUPPORT

Audit Readiness Assessments:

  • Site Assessments

  • QMS Checkup

  • Data Integrity

  • Compliance of Manufacturing, Laboratory Processes & Equipment, IT, Infrastructure

Remediation:

  • 483, Warning Letter, Consent Decree & External/Internal Inspection remediation

  • FDA Inspection Defense using our FDA Consortium member

  • Pro-active remediation of systems, equipment & processes

Supplier Quality Audits

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VALIDATION

Computer Systems:

  • Quality IT– Trackwise (Complaints, CAPA, CCM, GSQ, NCR), LMS, EDMS, PLM, BI

  • RA IT– ArisG, Argus, RA Publishing

  • Manufacturing IT– ERP, MES, Tech Services Platforms, UDI

  • Commercial IT– Software as Medical Device (SaMD), CRM, Salesforce

  • R&D/Clinical IT– LIMS, ELN, CTMS, Empower

  • Infrastructure & Facilities

Equipment/Process:

  • Lab & Manufacturing Equipment

  • Software Tools

  • Cleaning/Process

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IMPLEMENTATIONS

Clinical Trial Development Support:

  • Biostatistics, Data Analytics & Statistical Programming from Development to Regulatory Submissions

Quality Systems Setup
(On-Premise or SaaS):

  • HP ALM

  • Daruma

  • Siemens Polarion

Serialization/UDI:

  • Setup

  • End-to-end Line Validation & Compliance

 
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QUALITY MANAGEMENT SYSTEM (QMS) SUPPORT

QMS Policies & Procedures Setup

Support with QMS Execution – CAPA, NCR, Complaints, Training, Supplier Quality

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CENTER OF EXCELLENCE (CoE)

CoE Setup:

  • Core-Flex Model

  • Onsite-Offshore Model

  • US-EMEA-APAC Resources

CoE Tools:

  • IT, Equipment, Process, Tool Validation Templates

  • Resource & Budget Estimation Tool

  • Resource Onboarding & Training Plans

  • Validation Tracking Tools