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Quality Services

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Quality Compliance Partners, Inc. (QCP) provides quality services to companies of all sizes from the early stages of development to large commercial companies.  Whether you are looking for assistance with development of quality systems, improvements, harmonization, special projects, support of day-to-day operations or remediation, QCP has the experience to address your needs.  QCP will work directly with your company to understand your objectives, develop a plan of action, and execute the plan to meet your quality and compliance goals.

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QCP Quality Services

QCP quality service areas include:

  • Quality Systems - development, improvement, harmonization or remediation

  • Quality Oversight - manufacturing, laboratory or clinical operations

  • ​Plant Quality

  • Quality Engineering

  • Data Integrity - policy, strategy, planning, assessments and implementation

  • Remediation - manufacturing processes, quality or compliance issues

  • Risk Mitigation and Responses to 483s, warning letters or consent decrees

                                                                              

 

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  • Quality System Design and Improvement (GMP, GLP, GCP)

  • Quality Manuals

  • Develop, enhance or harmonize policies, procedures and SOPs

  • Quality Assessments

  • Provide a gap analysis and recommendations for compliance with US/EU/Other Standards

  • Development or enhancement of Quality Assurance Subsystems

  • Manage or assist with daily or periodic quality assurance activities, special projects or help with backlogs

  • Document Management/ Document Control

  • Conduct (Data Integrity) assessments to ensure overall completeness, accuracy and consistency of data

QCP Quality Services

QCP quality professionals have a range of hands-on experience

  • Vendor Management & Qualification

  • QA Guidance for Contract Manufacturers and Laboratories

  • Quality Reviews

  • Investigations – lead, conduct, write or review

  • Risk Assessments

  • Deviation Management and Support

  • Corrective and Preventive Action (CAPA) – planning and execution

  • Master Batch Record Reviews (MBR)

  • Shop Floor Quality Mentoring

  • Annual Product Review (APR)

  • Post Marketing Surveillance

  • Product Complaint Handling (including writing MDRs and MDVs)

  • Inspection Readiness

  • QA Support for Technology Transfer

  • Stability Programs and Data Review

QCP Quality Services

  • Design Control - assess and develop programs

  • Design History Files (DHF) - review and maintenance

  • Device Master Record (DMR) - review and maintenance

  • Device Histroy Record (DHR) - review and maintenance

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QCP Quality Services
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