Arbour Group understands the mission-critical importance of having a fully qualified manufacturing environment.
Arbour Group’s Process Validation Services involve a comprehensive and in-depth exploration and evaluation of every aspect of the manufacturing environment.

Through the use of proven methodologies and time-tested validation tools, our exhaustive examination and resulting recommendations focus on compliance with regulatory requirements.

With extensive, hands-on process validation experience, Arbour Group’s professionals have a proven system in place to offer clients a turnkey approach to validating their manufacturing process.

Manufacturing Process Validation

As a global leader specializing in providing a full scope of validation services for computer systems, facilities and manufacturing processes and devices within pharmaceutical and medical device companies worldwide, Arbour Group L.L.C. understands the mission-critical importance of having a fully qualified manufacturing environment. Our validation professionals are thoroughly familiar with the current FDA requirements for validation and have the technical expertise, the management foresight and the international support systems to help our clients ensure that all elements of the manufacturing process are validated in compliance with applicable regulations to minimize their business risk and to enhance their ability to compete successfully in the marketplace.

Arbour Group's Process Validation Services involve a comprehensive and in depth exploration and evaluation of every aspect of the manufacturing environment, including but not limited to:

• Manufacturing Facilities
• Utilities and Related Services
• Equipment and Maintenance
• Cleaning
• PLCs and SCADA Systems
• Manufacturing and Packaging Processes

Through the use of proven methodologies and time-tested validation tools, our exhaustive examination and resulting recommendations focus on compliance with regulatory requirements including cGMPs (21 CFR Part 211), Electronic Records and Signatures (21 CFR Part 11) and Quality System Regulations (21 CFR Part 820) and effectively reduce validation time to benefit. A value-added result of our validation process is to address issues of product quality as they impact a client's potential for success in a highly competitive marketplace.

Arbour Group's Process Validation Services include the following deliverables:

• Validation Master Plan
• Validation Project Plan
• Validation SOPs
• Validation Protocols
• Validation Summary Reports and Recommendations

With extensive, hands-on process validation experience, Arbour Group's professionals have a proven system in place to offer clients a turnkey approach to validating their manufacturing processes. Our process validation services can be as expansive as the development and implementation of a validation program for an entire manufacturing operation or as focused as a specific project tailored to an individual facility, utility system, equipment, manufacturing process or software application. The bottom-line benefit of Arbour Group's Manufacturing Process Validation Services translates to effective business risk management, enhanced product quality and, ultimately, increased market share.