Pharma  -  Biotech  -  Med Device  -  Mobile Medical Apps 

Accelerate the growth of your business with integrated templates, services and software.

  • Turn-key SOP templates are easily adapted to your business

  • Strategic services quickly launch your quality program

  • Implement industry best-practices to capitalize on evolving life sciences solutions

Example Programs

Systems Management

  • CSLM Methodology

  • Regulatory Applicability and Criticality

  • Access Management

  • Change Control

  • ERES / Annex 11 Assessment Procedure

  • Training

  • Vendor Audit

  • Backup / Restore / Archiving

  • Disaster Recovery Planning

  • Business Continuity Planning

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Quality Systems:

  • SaaS Governance Model

  • Quality Systems Road Map

  • Documentation Management / Numbering

  • Incident Management

  • Periodic Review

  • ERES Policy

  • IT Security

  • Records Management

  • Data Privacy (GDPR) Policy

  • Vendor Management

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  • Validated, Part 11 compliant software that automates the process.

  • Manage SOPs from Draft to Obsolete states with detailed version control.

Smart Document Management

Res_Q Analytics

Integrated Lifecycle Management

Electronic Change Management

Make your Quality System a Strategic Asset.

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