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Quality Management System (QMS)

D-Anchor QR& C LLC’s quality and compliance specialists hold extensive knowledge and experience in relevant regulations, guidance, and best practices that ensure proper management of the quality systems throughout the regulated life science industries. our services cover:

  • Procedure Development
  • GAP Assessments and Remediation
  • Non-Conformance & CAPA Management
    • Non-Conformance/Deviation Investigation Management Support
    • Process Analysis & Enhancement
    • Investigation, Corrective and Preventive Action Plans, and Effectiveness Check verification.

Commissioning, Qualification & Validation

We work collaboratively with our clients and business partners to plan, execute, validate, and monitor the effectiveness of Validation/Qualification endeavors throughout the project lifecycle. Whether it is drafting of protocols for execution and creation of Final Reports for equipment, facility, and Process/Product Validation, D-Anchor QR & C LLC. can assist with:

  • Validation Master Plans (VMPs)
  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)

Auditing and Remediation

D-Anchor QR&C LLC’s quality professionals will work closely with your staff to perform detailed audits of your existing quality systems to identify potential risks, recommend appropriate corrective and preventive actions in preparation for upcoming regulatory inspections and increase compliance with all aspects of cGxP.

cGMP, cGLP, Vendor/Supplier Auditing Services provided are:

  • Mock FDA audits and Gap Analysis
  • Formal risk assessments & risk mitigation strategies
  • Quality system and SOP gap analysis
  • Corrective actions and implementation plans, executions, and follow-up effectiveness checks.
  • Planning and execution of remediation projects
  • Validation and Qualification
  • Training and development of training programs
  • Quality management system
  • Qualification of GMP and GLP facilities
  • Vendor/Supplier audit plan preparation, execution, and management for validation and Qualification
  • Audit report preparation