QUALITY ASSURANCE &

COMPLIANCE

We provide effective and efficient solutions to meet quality system and regulatory compliance requirements with significant improvements in product quality and product workflows. AltaQ's team has extensive experience working with the FDA requirements covering 21 CFR parts 820, 211, 210, 1271, and 606. We have developed and implemented integrated quality systems supporting FDA and international regulations and standards. 

QUALITY SYSTEM REGULATIONS (CGMP)

  • Quality System Development

  • Quality System Gap Analysis

  • Compliance Program Audit

  • Mock Regulatory Audits

  • CAPA Program Implementation

  • Quality Audits

ISO Standards

  • ISO 13485 - QMS (Medical Devices)

  • ISO 9001 QMS (General)

  • ISO 14971 (Risk Management)

  • ISO/IEC 62304 - Medical Device Software 

Design Control

  • Design Control Implementation and Training  

  • Electronic Design Control Systems

  • Project Management and Design Control

  • Clinical Trials and Design Control

  • Design History Records and Data Management

ELECTRONIC QUALITY MANAGEMENT SYSTEM

  • Electronic Document Management System (eDMS)

  • Electronic Quality Management System (eQMS)

  • Validation of eDMS and eQMS

  • Training of eDMS and eQMS

  • Maintenance and Management of eMDS and eQMS

E-mail: info@AltaQ.com

1666 Connecticut Ave NW

Washington, DC 20009

Telephone: 301.263.0544

Fax:            509.694.9964