Regulatory Compliance Associates Inc. has extensive validation experience. We utilize this experience to provide complete validation services to the pharmaceutical, medical device and biotechnology industries. Focusing on a risk-based approach to identify the proper level of validation for your Facility, Utilities, Equipment, Processes, and Computer Systems we will help develop a prioritized plan, based on the identified risks.
Master Planning
The Validation Master Plan identifies the validation approach, the key elements of validation, validated system boundaries, schedule, and responsibilities; it is the guiding document for a given validation effort. Regulatory Compliance Associates 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.