VTI
can perform the following Auditing Related Services for you:
- Gap Analysis
- PAI Audits
- QSR/ISO Training
- Internal Auditor Training
- Internal Auditor Training
- Design Control Implementation, Audits & Assessments
- Risk Assessment & Hazard Analysis Consulting
- Quality Systems Assessments
- Quality System Design and Implementation
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Validation Technologies Inc. (VTI)
audit services follow a proven methodology to evaluate organizational
structure, policies, procedures, and practices concerned. Our
areas of expertise include FDA, EU, and ISO regulatory issues,
in addition to quality system development and implementation. We
also perform internal and external audits, provide training
and assist in working with FDA on compliance issues such as
483's and FDA Warning Letters. They're aimed at identifying,
evaluating, and eliminating potential weaknesses that could
undercut the realization of business objectives or compliance
with legal and regulatory requirements. Validation Technologies
Inc. (VTI) in-depth familiarity with accepted industry standards
and best practices, FDA regulatory requirements, and HIPAA supports
you in achieving and maintaining regulatory compliance. Our
approach includes:
- Assessing your objectives, regulatory adherence, processes,
methodologies, and technologies
- Utilizing our standard Auditing SOP or developing a customized
audit plant o meet your specific needs
- Conducting an audit based on the plan developed as a result
of the risk assessment prioritization
- Prioritizing identified risks and developing a remediation
plan to address them
- Training internal resources
Risk Management is a critical element
of any project. Risk Management is made up of two important
elements - probability and impact. The intent of Risk Management
is to manage each of these factors so that you can minimize
the negative impact or maximize the positive impact. Before
you can manage them, you have to identify and then assess
them. VTI's Project Managers have the background, experience,
and proven track record to help maximize the positive impacts
in your risk management.
Quality Systems Assessments: A thorough
review of your existing quality systems using our established
auditing and assessment procedures will help to identify the
strengths, issues, and opportunities for improvement within
your quality program.
Quality System Design and Implementation:
VTI Consultants have the hands-on expertise to produce customized,
simple and effective programs to implement their recommendations
and meet your needs. They also have the project management
skills and the ability to work with all levels of your organization
to implement a comprehensive quality system.
- Additional Services also include:
- Gap Analysis
- PAI Audits
- QSR/ISO Training
- Internal Auditor Training
- Design Control Implementation, Audits & Assessments
- Risk Assessment & Hazard Analysis Consulting
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