VALIDATION SERVICES

QCP Validation Services
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QCP, Inc. has extensive validation experience. We utilize this experience to provide complete validation services to the pharmaceutical, medical device and biotechnology industries.  We focus on a risk-based approach to identify the proper level of validation for your specific validation area.  We can help develop a prioritized plan, based on the identified risks.

Master Planning

The Validation Master Plan (VMP) identifies the validation approach, the key elements of validation, validated system boundaries, schedule, governing regulatory requirements, traceability matrix and responsibilities; it is the guiding document for a given validation effort. QCP, Inc. develops technically sound, practical and compliant Validation Master Plan, which is tailored to fit our client’s specific needs.

Protocol Development and Execution

Regulatory Compliance Associates Inc. offers comprehensive experience in team-based, cross-functional protocol development and execution. Our validation team leaders and specialists are experts in organizing validation teams to properly represent the organization, and are proficient in current industry practices and regulatory guidance related to protocol writing and execution.

Standard Operating Procedure Development

Regulatory Compliance Associates Inc. evaluates new or existing systems and equipment, creates comprehensive procedures, and provides training structured around those procedures to meet and maintain cGMP compliance.

Management of Change

Our staff plans, organizes, and authors multi-level MOC programs, and trains client staff in program implementation. We assist in creating meaningful compliance measurement tools, or can create turnkey spreadsheet and graphs for our client’s staff to measure their program’s progress.