201 Strykers Road, Suite 19-246
Lopatcong, NJ 08865
The Red Summit Compliance staff has over 20 years of experience in FDA-regulated industries through its consultants. These consultants have successfully established and maintained ISO-certified and FDA-compliant quality and clinical systems in the medical device and In Vitro Diagnostic fields.
Red Summit can work with your organization to address your FDA compliance needs and to ensure processes meet all necessary regulatory requirements. Experience in medical devices/IVDs qualifies us to assist you with Quality System compliance, FDA regulations, FDA QSIT audits, cGMPs, FDA inspections and responses.
Our Compliance Services deliver consistent and effective results. We provide strategic approaches to address your specific business needs and provide creative, efficient solutions that will align with your organization.
Red Summit's industry-trained consultants can assist in the implementation of new quality systems or improvement of existing quality systems:
- Assistance in implementation of and/or improvements to ISO and FDA compliant quality systems
- Provide full support for computer system validations: planning, execution, documentation
- Part 11 Compliance Analysis including auditing of GLP / GMP / GCP systems and data.
- System Qualifications: IQ, OQ , PQ
- Risk Assessments and Hazard Analysis
- Reviews of compliance documents and records
- Develop Controlled Documentation Systems, including electronic systems
- Implementation of Part 11 compliant electronic systems for quality records
- Gap Analysis
- Analysis, development, and documentation of QA and Clinical Standard Operating Procedures and protocols
- GMP, GLP, GCP, QSR, and ISO Training
- GMP Audits / mock FDA audits
- Supplier Audits
- Root Cause Analysis
- Corrective and Preventive Action (CAPA) planning, implementation, and follow-up
- Internal Audit Support
- Review of process validation, operations and procedures
- Auditing of clinical data, investigator sites; IRB and CRO assessments, and site monitoring
- FDA submission and technical file creation and support
- Customized services and support
Red Summit Consulting will provide:
- Proactive approach to implementation strategies through thorough planning
- Responsiveness to customer needs
- Team approach - we partner with your organization to work closely with you on all projects
- Demonstrated ability to handle multi-faceted projects
The compliance branch of Red Summit has worked with organizations ranging in size from start-ups to Fortune 500 companies to establish and maintain ISO-certified and FDA-compliant quality management and clinical affairs systems in the medical device and In Vitro Diagnostics fields.
The software implementation team focuses on implementing and validating EtQ brand Quality Management System software following best-in-class GAMP methodologies.
The Clinical Trial Services division provides clinical trial protocol development, study monitoring, and study management services for trials conducted worldwide (North America, Europe, Asia and Africa).
For more information about Red Summit Consulting, please contact us via e-mail: firstname.lastname@example.org
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