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.

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.

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