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21 CFR Part 11 Assessment Audits
and Remediation |
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The Auditing Group, Inc. (TAG) offers comprehensive on-site and
off-site audits and remediation assistance to ensure that your company is
capable of meeting and exceeding strict FDA and/or sponsor compliance
audits. During the audits, we review applicable documentation,
interview key quality assurance, support and management personnel, and
address the following regulatory issues:
- Company organization
- SOPS, policies and guidelines
- Personnel qualifications and training
- System design and specification
- System development/implementation
- Testing
- Change control
- Quality assurance
- User documentation
- Installation and maintenance
- Security and recoverability
- Facilities management
A written report summarizes the audit results and provides the client
with specific recommendations to mitigate any technical or regulatory
risks discovered.
- Identify specific systems that fall under the scope of 21 CFR Part
11 and evaluating the potential regulatory issues for each
- Determining if existing policies and procedures are consistent with,
and conducive to, developing and deploying 21 CFR Part 11 compliant
systems
- Developing a remediation plan to address regulatory issues:
- stratification of systems according to risk
- identification of specific system issues and corrective measures
- establishment of roles and responsibilities
- determination of resource requirements
- creation of milestones and target dates.
Implementation Assistance
TAG provides professional consulting and expert implementation
assistance to help clients remediate any 21 CFR Part 11 regulatory
issues:
- Validation plan development
- Education and training
- Documentation development
- Vendor audits
- Security reviews
- SOP development
- Test plan development and execution
- Quality assurance
- Development methodology review/evaluation
- Validation 'gap' analyses
- Validation Consulting Services
- Clinical Data Management Services
- Monitoring Services
- Quality Assurance Services
- Information Technology Consulting Services
- Contract Programming and Software Development Services
- Patient Cost Analysis Services
- Document Management Consulting Services
- Needs Assessment Services
- Metrics and Best Practices Services
- Training and Documentation Services
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21
CFR Part 11 - Quality Systems Initiatives. Remediation & Auditing |
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Computer Systems and Software Validation Auditing |
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Clinical Data Management Software |
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Electronic Data Capturing (EDC) Systems |
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Supplier / Vendor Compliance Audits |
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FDA
Preparations, Resolutions and 'For Cause'. |
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GVP -
Good Validation Practices Training |
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Equipment / Process Validation - Ethical, OTC, R&D and Manufacturing |
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Validation / Verification / IQOQ Gap Analysis & Risk Assessments |
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Facility & Process Start-ups, Scale-ups & Commissioning |
The Computer Systems Validation Guidelines
LIMS Installation, Upgrade & Validation
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21 CFR Part 11 & Computer System Validation
Audits... Assuring compliance with
21 CFR Part 11 regulations requires detailed examination and evaluation across
systems, products, processes and functions within your organization.
The Auditing Group has the perspective, objectivity, experience,
expertise and services to help ensure your Company's compliance.
The Auditing
Group helps companies develop strategic plans for complying with 21
CFR Part 11 by:
- Providing regulatory
requirements and applicable guidance policy training to
- Pre-Clinical and
Clinical Research
- Clinical Data
Management
- Regulatory Affairs
- Information
Services
- Software
Development
- Quality Assurance
personnel
- Identifying the
specific systems that fall under the scope of 21 CFR Part 11 and
evaluating
the potential regulatory issues for each
- Determining if
existing policies and procedures are consistent with, and
conducive to,
developing and deploying 21 CFR Part 11 compliant systems
- Developing a
remediation plan to address regulatory issues:
- stratification of
systems according to risk
- identification of
specific system issues and corrective measures
- establishment of
roles and responsibilities
- determination of
resource requirements
- creation of
milestones and target dates.
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The Auditing
Group' audits help clients identify their specific areas of risk
regarding 21 CFR Part 11 compliance of systems,
procedures, documentation and controls. During the audits, we review applicable
documentation, interview key quality assurance, support and management
personnel, and address the following regulatory issues:
- Company organization
- SOPS, policies and
guidelines
- Personnel
qualifications and training
- System design and
specification
- System
development/implementation
- Testing
- Change control
- Quality assurance
- User documentation
- Installation and
maintenance
- Security and
recoverability
- Facilities management
A written report
summarizes the audit results and provides the client with specific
recommendations to mitigate any technical or regulatory risks discovered.
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The Auditing
Group provides professional consulting and expert implementation
assistance to help clients remediate any 21 CFR Part 11 regulatory issues:
- Validation plan
development
- Education and
training
- Documentation
development
- Vendor audits
- Security reviews
- SOP development
- Test plan development
and execution
- Quality assurance
- Development
methodology review/evaluation
- Validation 'gap'
analyses
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The Auditing
Group Can Also Provide...
- Validation Consulting
Services
- Clinical Data
Management Services
- Monitoring Services
- Quality Assurance
Services
- Information
Technology Consulting Services
- Contract Programming
and Software Development Services
- Patient Cost Analysis
Services
- Document Management
Consulting Services
- Needs Assessment
Services
- Metrics and Best
Practices Services
- Training and
Documentation Services
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