cGMP Validation LLC
Consulting firm (est. 1997) providing commissioning, qualification, validation, and GMP compliance services for pharmaceutical, biologics, biotech, medical device, diagnostics, and animal-health manufacturers. Services include development and execution of validation protocols, computerized systems validation, utility and facility qualification, auditing and regulatory consulting, and training. Projects have been completed domestically and internationally.
Industries
Nr. of Employees
medium (51-250)
cGMP Validation LLC
4770 N. Belleview Ave., Suite 201, Kansas City, MO 64116, USA
Products
Validation IQ/OQ/PQ Protocols
Preparation and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for equipment, utilities, processes, laboratory instruments, and computer systems.
Compliance Documentation
Development of documentation to demonstrate compliance of equipment, utilities, processes, laboratory instruments, and computer systems with regulatory standards.
Auditing, Risk Assessment, and Compliance Consulting
Services that include auditing, risk assessment, and consulting to evaluate and improve compliance with regulatory standards in pharmaceutical and related industries.
Educational Training Programs
Training programs designed to educate personnel on validation, compliance, and regulatory requirements in pharmaceutical and related industries.
Computer System Validation (CSV)
Validation services for computer systems to ensure compliance with regulatory requirements, including 21 CFR Part 11.
Validation IQ/OQ/PQ Protocols
Preparation and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for equipment, utilities, processes, laboratory instruments, and computer systems.
Compliance Documentation
Development of documentation to demonstrate compliance of equipment, utilities, processes, laboratory instruments, and computer systems with regulatory standards.
Auditing, Risk Assessment, and Compliance Consulting
Services that include auditing, risk assessment, and consulting to evaluate and improve compliance with regulatory standards in pharmaceutical and related industries.
Educational Training Programs
Training programs designed to educate personnel on validation, compliance, and regulatory requirements in pharmaceutical and related industries.
Computer System Validation (CSV)
Validation services for computer systems to ensure compliance with regulatory requirements, including 21 CFR Part 11.
Services
Commissioning and qualification of equipment, utilities, laboratory systems, processes and facilities; IQ/OQ/PQ protocol development and execution; FAT/SAT support.
Validation and remediation for computerized systems, supplier audits, risk assessments, data migration planning, and Part 11 gap analyses.
Vendor and internal audits, quantitative risk assessments, preparation for inspections, QA/QC documentation review, and regulatory remediation planning.
On-site and custom training on GMPs, validation protocol development and execution, FDA inspections, and facility design; provision of training documentation.
Preparation of validation master plans, URS, SOPs, specifications, calibration and preventive maintenance procedures, and sample handling/environmental monitoring procedures.
Commissioning and qualification of equipment, utilities, laboratory systems, processes and facilities; IQ/OQ/PQ protocol development and execution; FAT/SAT support.
Validation and remediation for computerized systems, supplier audits, risk assessments, data migration planning, and Part 11 gap analyses.
Vendor and internal audits, quantitative risk assessments, preparation for inspections, QA/QC documentation review, and regulatory remediation planning.
On-site and custom training on GMPs, validation protocol development and execution, FDA inspections, and facility design; provision of training documentation.
Preparation of validation master plans, URS, SOPs, specifications, calibration and preventive maintenance procedures, and sample handling/environmental monitoring procedures.
Expertise Areas
- Commissioning and qualification
- Computerized systems validation (CSV)
- GMP compliance and regulatory consulting
- Process and product validation
Key Technologies
- Laboratory Information Management Systems (LIMS)
- Gas chromatography (GC)
- High-performance liquid chromatography (HPLC)
- DNA and peptide sequencers
News & Updates
Company established in 1997 providing validation and GMP compliance consulting.
States completion of over 70,000 validation protocols.
States completion of over 3,500 projects globally.
Company identifies as privately held and profitable since its inception.
Company established in 1997 providing validation and GMP compliance consulting.
States completion of over 70,000 validation protocols.
States completion of over 3,500 projects globally.
Company identifies as privately held and profitable since its inception.