Validation and Compilance

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Validation and Qualification Services

Advisory and Guidance Services

Quality Services

RCM has been providing comprehensive Validation Services for over 40 years. Our team has the expertise to support projects of all sizes.

RCM provides the resources required to get the project done right, on time, and on budget.

Complete, customized end-to-end Validation programs include:

• Construction projects
• New facilities start-ups
• Full-scale commercial production campaigns
• Installation and Operational Qualification of a single piece of equipment
• Validation of a new process within an existing facility.

Validation Services Surrounded by Continued Process Verification, Process Design, Facility Design, Utilities & Equipment Qualification (IQ/OQ/PQ)

Process Validation

Developing a process validation strategy early in clinical development is critical for a successful validation program.

Equipment Qualification

RCM can provide the expertise to assess your equipment compliance and ensure reliable performance.

Facilities Validation

Facility validation provides the documentation necessary to demonstrate the foundation for the facility and its utility systems.

Computer Softwear Validation

Computer System Validation is the process of documenting that a computer system meets a set of defined system requirements.

Manufacturing Validation

RCM can provide the expertise to plan, expedite, and execute your manufacturing validation services.

Cleaning Validation

RCM’s team members are knowledgeable in the latest cleaning techniques and technologies.

FDA Guidance

New technical competencies need to be developed through learning management programs to train employees on the new FDA guidance.

Quality Assurance

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Bill Gargano

Group SVP