CyberVal Pharma, Inc.
1200 Route 22 East
Scientific * Regulatory * Technical * Consulting Services
CyberVal provides industry solutions for pharmaceutical, biotech, and medical device manufacturers. CyberVal specializes in providing consulting services for complex implementations requiring prior industry experience with regulated local area networks, laboratories, and preparing customized documentation suitable for review and acceptance by regulatory auditors.
- Validation Services for computerized data systems, custom, commercial applications and process analytical technologies. Targeted validations and revalidations based on risk analysis models. CyberVal utilizes a risk based approach for targeting the validation effort. Based on well defined user requirements and regulatory guidelines, a risk model is developed to document and identify critical path processes.
- Project Management services for laboratory informatics, chromatography, CAPA, eCTD, document management, computer networks, upgrades and vendor selection. Clinical Trial data management. CyberVal can enter any stage of a project and play a lead role to contribute to project success. New implementations and system upgrades require the proper analysis to develop meaningful timelines and budget projections. Resource management and working with the client to achieve a common goal. CyberVal professionals take responsibility in working as part of a team interacting with client and contract resources.
- Network Qualifications for existing and new networks. Server qualifications, workstations, notebooks, email policy, and data directory restructuring. Security analysis, public key infrastructure, and procedural training is offered. CyberVal performs assessments of the current local area network environment as it pertains to regulatory requirements and works with the internal Information Technology Professionals to develop a sound procedural and technical remediation strategy.
- Compliance services for GMP, SOX, HIPAA, Clinical Trials, Quality Assurance, Risk Analysis, GAP analysis, consent decree remediation, and 483 responses. 21 CFR Part 11 Specialists. Procedures and customized training module development. Targeting compliance goals eliminates misguided resource allocation. Knowledge of applicable guidance and industry practices provides reasonable assurance that various compliance objectives are realized. CyberVal provides a wide range of compliance services designed to achieve compliance by developing an appropriate interpretation of regulation based on client-specific scientific and business principles.
- Laboratory chromatography data system qualifications for instrumentation and computerized systems - all vendors. Informatics workflow models are developed to identify trigger relations. CyberVal specializes in chromatography data system implementations and upgrades. Instrumentation qualification protocols and computer data system validation are available for all chromatography vendor products.
- Informatics Validation and design analysis using workflow models developed to identify trigger relations and areas of opportunity for enhancements. Laboratory Information Management System validation for all vendors CyberVal specializes in biotech startup companies and organizations in transition from non-regulated to regulated environments. Biopharma instrument implementations and validation including plate readers, ELISA, HPLC, GC, imaging systems, spectrophotometers, and analyzers.
Last Updated: 06-13-05
CyberVal Pharma, Inc.