Source: http://www.auditing.com/part11audits1.htm
Timestamp: 2017-03-25 17:27:19
Document Index: 51857020

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 820']

GXP Audits - Remediation - Validation - Training
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.
TAG helps 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. 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 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 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
The Computer Systems Validation Guidelines
LIMS Installation, Upgrade & Validation
21 CFR Part 11 - Quality Systems Initiatives. Remediation & Auditing
Computer Systems and Software Validation Auditing
Electronic Data Capturing (EDC) Systems
Supplier / Vendor Compliance Audits
FDA Preparations, Resolutions and 'For Cause'. GVP - Good Validation Practices Training
Equipment / Process Validation - Ethical, OTC, R&D and Manufacturing
Validation / Verification / IQOQ Gap Analysis & Risk Assessments
Facility & Process Start-ups, Scale-ups & Commissioning
Pharmaceutical - Medical Device - Clinical - Laboratory - Part 11 - Food - Dietary Supplement Not sure if your company can pass
a GMP, GLP, GCP, Quality Systems, -
Part 11 & QSR Part 820 audit? Get an independent assessment of your quality and regulatory readiness today! Turn Key 3-day On-Site GMP/API, Mock FDA or Systems Audits