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CyberVal provides industry solutions for pharmaceutical, biotech, and medical device manufacturers. CyberVal specializes in providing consulting services for complex
Quality System implementations requiring prior industry experience with regulated local area
and enterprise networks, laboratories, and preparing customized documentation suitable for review and acceptance by regulatory auditors.
Business Analysis for implementations. |
Validation
Computer System / Application targeted validations and revalidations based on
requirements and risk analysis models. 21 CFR FDA
regulatory compliance and GAMP guidance models. |
Project Management
Services for LIMS, CAPA, eCTD, CDS, SDMS, QMS, DMS, ELN,
and ERP. Business Analysis and Requirements Gathering.
Project Planning, Workflow Analysis, and System
Upgrades. |
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Network
Server, Workstation, Thin-Client Qualifications for existing and
new network segment infrastructures for implementation.
LAN / WAN Network Qualifications to ensure ISO and cGMP
compliance. |
Compliance
Quality Assurance services for cGMP, FDA, EMEA, ISO,
Audits, Quality Review, and Risk Analysis. 21 CFR Part 11 Specialists. Procedures and customized training module development. |
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Laboratory
CDS, LIMS, Quality Systems implementations and
upgrades. Instrument qualification and data management
audits and workflow analysis and procedures. |
Contact:
Direct: (908) 745-1689
Email:
info@cyberval.com |
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