Handbooks >Drug GMPMedical DeviceClinical - LaboratoryBiologic-Blood-TissueCosmetic-Food-DietaryElectronic SystemsEU - ICH - Misc.More...

Auditing and Validation Services for FDA Regulated Industry

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
Clinical Data Management Software
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

Schedule your audit now

GMP Boot Camp!

  >>  Auditing Services   >>  Remediation Services

GMP, GCP, GLP, QS and Part 11 / Systems Audits

21 CFR Part(s) 11, 210/211, 820, ICH Q7

Food and Supplement GMP Audits

Mock FDA - EMEA Audits

Pre-Site Inspections - 'For-Cause'

Quality Assurance Audits

Quality System Audits - Part 820

SOPs, Quality Assurance and Standards Audits

GMP - Good Manufacturing Practice Audit

GCP - Clinical Audits - Regulatory Audits

Equipment Validation Documentation Audit

Software / Systems Validation Audits

Part 11 / Annex 11 Compliance

Vendor & Supplier Audits -

CMOs, Laboratories, API Manufacturers

CROs, Investigators, Monitors, and Study Sites

Database Audits, SAS, CMMS, eDC, eCFR, Safety

Project Management and Support Services

Gantt and Timeline Development

Validation Development and Executions

Training Services

Template Implementation

Procedures and Practice Challenges

Standard Operating Procedures Development

Development Part 11 Initiatives

Design / Build Engineering Services

Certified AIA 'As-Built' Drafting Services

Process and Equipment Validation Services

Software and Systems Validation Services

Design / Build Engineering Services




GMP Publications

GXP News for the Regulated Industry Whats new with the FDAGXP Academy
GXP Recruiters - Recruiters for the BioPharmaceutical Industry

2002 - 2013 The Auditing Group, Inc., a New Jersey Corporation. All rights reserved
Home  |  Contact Us  |  Site Map

Auditing - Full Service Auditing Services