IT
Quality Systems Services
V2 Bio-Consulting offers information systems and regulated IT consulting
services for the specific needs of BioPharma, BioFuels and Chemicals,
and Industrial companies ranging from small start-ups to fully integrated
companies with commercial products. From initial planning to go-live
and production support, V2
Bio-Consulting has a strong background
in all phases of the GMP or GCP information systems project life cycle.
Our validated systems experience includes Laboratory Information Management,
Document Control, Clinical Trials Management, Quality Management, and
Enterprise Resource Planning (ERP). We have knowledge and experience
with IT strategy, governance, policy, risk management, automation, and
operational processes and procedures in multi-regulatory settings.
We offer GMP, GCP as well as Sarbanes-Oxley audit services of IT operations
and information systems.
Project Management for automated
business systems including qualification and validation:
Full Project Life Cycle with soft/hard
gate stages and standardized deliverables: propose > initiate
> acquire > plan > design
> build > test > deploy > support
We approach projects from the user perspective
while attending to IT objectives minimizing resources and on-going cost
of support and maintenance. We have strong cross functional business
process knowledge and experience designing, implementing and supporting
common business systems:
GCP including
Clinical Trials Management, Safety-Adverse Events Reporting
GMP including
Quality Management Systems, Document Control, Lab Information Management,
Chromatography Data Systems and Enterprise Resource Planning
IT
and Information Systems Audit Services:
Strategy and project planning
for achieving and maintaining FDA and Sarbanes-Oxley compliance
Staff augmentation for business
process subject matter experts and IT professionals to prepare for or
conduct audits
Plan and conduct information
systems and data security audits for outsourced clinical data management
services as well as contract laboratory and manufacturing vendors
Assess the effectiveness of
IT processes and procedures of your internal or outsourced IT operation,
identify deficiencies and gaps, make recommendations and oversee action
plans to eliminate or mitigate risks to data security, integrity, availability,
and regulatory compliance for FDA and Sarbanes-Oxley
Liaison with external auditors
and help your IT and information systems teams prepare for regulatory
audits
www.v2bio.com