Validated Building Services, LLC, provides Validation services to the life science community. Our validation professionals have hands-on experience in pharmaceutical, medical product and biotechnology manufacturing and research facilities. Our team is driven by your needs for cost effective validation, aggressive scheduling and regulatory compliance. Our validation professionals have operating company experience and especially understand the importance of complying with standards set by regulatory agencies such as the Food and Drug Administration (FDA). Our validation professionals provide programs and documentation that establish with a high degree of assurance that your facilities, processes and equipment consistently meet your predetermined specifications.

Validation Services: Master Validation Plans Gap Analyses Current Good Manufacturing Procedure (cGMP) Assessments Risk Analyses Good Automated Manufacturing Practice (GAMP) Assessments Electronic Records and Signatures 21 CFR Part 11 User Requirement Specifications Functional Requirement Specifications Detailed Design Specifications Traceability Matrixes Installation Qualification Protocols Operational Qualification Protocols Performance Qualification Protocols Vendor Audits Factory Acceptance Testing Site Acceptance Testing Commissioning Protocol Executions Root Cause Analyses Deviation Remediation Standard Operating Procedures Validation Summary Reports

Validation Services Scope: Heating, Ventilation and Air Conditioning (HVAC) Building Automation Systems (BAS) Refrigeration Environmental chamber monitoring systems USP purified water systems Deionized water systems Water-for-Injection (WFI) systems Clean-in-Place (CIP) systems Compressed air systems Clean steam generation systems

 

 

The following sample projects demonstrate the expertise of our professionals:

Project Summary: Developed project management plans and cost estimates for computerized Building Automation Systems (BAS) and Environmental Chamber Monitoring Systems (ECMS) to ensure compliance with Food and Drug Administration (FDA) 21 CFR Part 11 regulations (electronic records and electronic signatures). The projects included a biotechnology manufacturing facility, clinical product stability environmental chambers, retained sample environmental chambers and a microbiology laboratory. Prepared Good Automated Manufacturing Practice (GAMP) and FDA 21 CFR Part 11 assessments and compliance strategy documents for existing and proposed BAS and ECMS including hardware, software and instrumentation. Managed and reviewed vendor audits with quality assurance personnel to ensure compliance with 21 CFR Part 11 and other compliance related requirements. Full validation life-cycle experience using the Software Development Life Cycle (SDLC) method to provide standardized, repeatable processes for system development, implementation and management. Significant cost savings realized for Johnson & Johnson by properly interpreting the new FDA 21 CFR Part 11 guidelines.

Project Summary: Authored and executed Good Manufacturing Practices (GMP) validation documents including Master Plans, Installation Qualification (IQ) protocols, Operational Qualification (OQ) protocols and Summary Reports for Food and Drug Administration (FDA) regulated pharmaceutical production facilities and equipment such as Heating, Ventilation and Air Conditioning (HVAC) systems, Building Automation Systems (BAS), USP Purified Water systems, Water-for-Injection (WFI) systems, Clean-in-Place (CIP) systems, compressed air systems and clean steam generation systems. Developed commissioning, qualification, validation, calibration, maintenance and cleaning protocols, and Standard Operating Procedures (SOP) in accordance with the FDA regulations 21 CFR Part 210 (cGMP in manufacturing, processing, packing or holding of drugs) and Part 211 (cGMP for finished pharmaceuticals). Developed project schedules, budgets and manpower loading, including the monitoring of project progress, completion of key milestones and deliverables, development of recovery plans, and reports to client management.

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