CyberVal provides Current Good Manufacturing Practice (CGMP) compliance services for:

FDA: 21 CFR Part 11: Assessments, Testing, Procedural / Technical

FDA: QSR 820: Test Method Validation, Verification & Validation  Plans, 510(k) preparation

ISO 13485: Alignment with QSR 820 <> ISO 13485 Requirements

Quality Audits: Internal, Supplier, Information Technology, Laboratory <> Plans / Reports

CSV: Targeted computer system validations using risk-based approach

GxP Quality Systems: CAPA, Remediation Plans, Investigations

GxP Laboratory Systems: Project Implementations <> Upgrades

Process Validation: Manufacturing Execution Systems, Process Control Systems

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.