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Professional Services

Life Science business consulting services for the Pharmaceutical, Biotechnology and Medical Device industries...

Business Development

Business development services include: program planning, project management and implementation support. Business process development and optimization. Quality Management System assessment, development and implementation. Validation program assessment and implementation. ERP assessment and validation support. Organizational training.

Computer System Validation

Computer System Validation services for enterprise systems across multiple industries: Pharmaceutical, Biotechnology and Medical Device. IT systems analysis, development and implementation. IT controls assessment and development. Validation services to meet best-practice Good Automated Manufactring Practice (GAMP) and SDLC standards.

Compliance Services

Electronic Records / Electronic Signatures Compliance. FDA cGMP Compliance (21 CFR Part 11, 210, 211, 820, 830). ISO Compliance (9001, 13485, 14971, 27001, 27002). SOX-404 Compliance. GAMP 5. Software Vendor Audits.

Professional Experience

Business Development and Compliance services for the Life Sciences Industry

Expertise: Industries / Business Systems / Compliance Standards

Industry experience: Pharmaceutical 18+ years, Biotechnology 9+ years, Medical Device 10+ years.

Computer System Validation (30+ years): FDA Guidelines, Commissioning and Qualification, GAMP 4/5, ASTM.

ERP systems (15+ years): SAP R/3 and ECC, JDE EnterpriseOne, Microsoft Dynamics AX, and IQMS EnterpirseIQ.

Electronic Record systems (17+ years): EDMS, QMS, GLS, CMS and UDI systems.

IT systems (17+ years): IT networks, RDBMS, BDR systems, and Middleware systems.

Lab systems (18+ years): LIMS, HPLC, GC, UV-Vis, Robotic testing, and Excel.

Clean Utility and Metrology systems (9+ years): DI, WFI, Clean Steam, CIP, SIP, CMMS and BMS systems.

Biotech Process PLC systems (9+ years): Bioreactors, Chromatography, Micro and Ultra-filtration.

FDA regulations (30+ years): FDA 21 CFR Parts 11, 210, 211, 820, and 830.

ISO standards (10+ years): ISO 9001, 13485, 14971, 27001, 27002; and ISO/TR 80002-2.

EU regulations (10+ years): Eudralex Volume 4, Annex 11 and Annex 15.

IT standards (17+ years): Best-practice IT controls, ITIL, ISACA / COBIT.

Resources...

Business, IT and Compliance resources

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