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Part 11 and Systems Audits...

Extensive experiane with all types of Electronic Systems, Software and Part 11 compliance requirements satisfying industry standards and regulatory compliance.

Professional experience

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.

Assisted Companies develop strategic plans for complying with 21 CFR Part 11 by:
•Providing regulatory requirements and applicable guidance policy training for: ◦ Pre-Clinical and Clinical Research
◦Clinical Data Management
◦Regulatory Affairs
◦Information Services
◦Software Development
◦Quality Assurance

•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.

Assisted with helping 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

Written reports summarizes the audit results and provides the client with specific recommendations to mitigate any technical or regulatory risks discovered.

•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

Provide 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

 


4 Linda Lane, Suite B, Southampton, NJ 08088 Tel: 609-217-7031

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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