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Auditing and Validation Services for FDA Regulated Industry
 

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Turn-Key GMP Compliance Solution

Turn-key GMP Compliance Program

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In an effort to assist firms with the tedious job of implementation of their quality management system, The Auditing Group, Inc. (TAG) provides turn-key option for implementation of the GMP Quality Compliance initiatives to ensure your quick success in meeting and exceeding FDA compliance requirements.  For a single price, TAG will provide your Company with all of the required procedure templates, and manuals to ensure your success is obtained in a short period of time.

The SOW would include, but not limited to;

  • 200 hours on-site template customization
  • 200 Consultancy hours off-site – GMP/TAG Offices
  • 120 hours off-site Quality Review and Project Coordinator
  • Engineering Audit Review
  • Develop Gantt Chart and Remediation Project Plan
  • Development of the Quality Manual / Quality Management Systems Requirements
  • Develop Training Program, Training Curriculum and Conduct SOP Training
  • Provide Procedure Templates for Site Qualification Plan and Basis of Design (BOD)
  • Provide Procedure Templates for IT and Computerized Systems SOPs
  • Write and Execute the 21 CFR Part 11 Compliance Initiative and Charter
  • Provide Procedure Templates for Quality Critical Procedures (SOPs) – See list below
  • One Audit Certificate provided by The Auditing Group, Inc. upon final signatures

Provide Template Standard Operating Procedures

    • Quality:
      • Quality Policy
      • Quality Manual
      • Procedure Development Procedure
      • GMP Conventions
      • The Quality Unit Responsibilities
      • Quality Audit Procedures - Internal
      • Quality Audit Procedures - Vendors and Suppliers
      • Quality Audit Procedures - Sponsors and Visitors
      • Quality Audit Procedures - Agencies
      • Vendor and Supplier Management Procedures
      • Quality Control Procedure
      • Good Laboratory Practice Procedure
      • Regulatory Affairs Procedure
      • Product Safety Procedure
      • Environmental Safety and Health (ESH)
      • Research and Development (R&D) Operations
      • Recall and Traceability Process
      • Change Control
      • Complaint Management
      • Risk Management Procedures
      • Corrective Action and Preventive Action (CAPA)
      • Non-Conformance
      • Out-of-Specifications (OOS)
      • Deviation Management
      • HACCP Quality Management Procedures and Practices
      • Document Management and Document Control (On-site/Off-site)
      • Document Review Process
      • Quality Management Review
      • Business Continuity
  • Quality Control and Analytical:
      • Good Laboratory Practice Standards
      • Quality Control and Testing
      • Cleaning Validation
      • Log Book Management
      • General Laboratory safety
  • Human Resources :
      • Training and Development – Training Curriculum Development
      • Employee Management Roles and Responsibilities and Job Descriptions
      • EHS Training for Plant Personnel and General Spills
  • Warehouse:
      • Warehouse Management
      • Material Receiving
      • Raw Material Sampling
      • Component Sampling and Testing
      • Label Management
      • Finish Product Sampling
      • Storage and Handling Procedures
      • Retains Sampling Procedures
      • Reserve Sample Procedures
      • Handling and Destruction of Rejected Material
      • Disposal of Process Waste
  • Production:
      • Process Validation
      • Batch Numbering System
      • Production Procedures
      • Packaging Procedures
      • Master Record Management (Development and Review)
      • Batch Record Management (Review)
      • Reprocessing / Rework
  • Facilities:
      • Facilities Management and Security
      • Sanitary and Housekeeping Procedures
      • Hygiene and Gowning Procedures
      • Pest Control Procedures
      • Water Systems Quality Procedures
      • Compressed Air Systems
      • Generator Backup Procedure
      • Asset Management (Equipment and Systems)
      • Equipment Validation and Qualification
      • Equipment Control and Asset Management
      • Maintenance Management Procedures
      • Calibration Management Procedures
      • Contractor Management
  • IT:
      • 21 CFR Part 11 Electronic Systems / EU Annex 11 Computer Systems
      • Backup and Recovery
      • Disaster Recovery
      • Backup and Recovery Challenging Process
      • Upgrade and Downgrade
      • Change Control
      • Configuration Management
      • Software / Systems Development Life Cycle
      • Development of Software/Systems User Requirements Specifications (URS)
      • Development of Software/Systems Functional Requirement Specs. (FRS)
      • Software Use Policies and Internet Usage
      • Software Risk Assessment
      • Hardware Risk Assessment
      • Network Access Policies
      • New Hardware Installation
      • New Software Installation
      • Hardware Maintenance
      • Software Maintenance - OEM and Internal
      • Computer Systems Hardware Testing and Validation - Writing Installation Qualifications, Operational Qualifications, and Performance Qualifications
      • Computer Systems Software Testing and Validation - Writing Installation Qualifications, Operational Qualifications, and Performance Qualifications
      • Virus Protection, Log reviews and Definitions updating processes
      • UPS and Redundant Power Supply
      • Imaging of computer systems (Clients and Servers)
      • Data Base Administrator (DBA) Procedures
      • Ghosting and/or Mirroring Processes
      • MS Excel Qualification
      • Off Site Storage
      • Tape Management, Chain of Custody and Degaussing Procedure
      • Internal Systems Audit
      • Vendor Qualifications, Hardware, Software, Consultants and Contractors,  ASPs/ISPs/IaaS/SaaS
      • Administrative Rights
      • Database Administrative Activities
      • Physical Security
      • Computer Room Management and Alarming Systems
      • Computer Room Environmental Systems and Alarming Systems
      • Help Desk Management
      • Drawing, Schematics, Flow Diagrams and other Quality Critical Document Management Practices
  • Clinical:
      • Serious Adverse Event Reporting (Clinical)
      • Investigator Site Audit and Monitoring (Clinical)
      • Good Clinical Practice (Clinical)
      • Clinical Supply Management (Clinical)

 

Capabilities:

The Auditing Group provides on-site independent pro-active GxP audit and consulting services to support your current practices, process and procedures providing comprehensive detailed reports identifying deficiencies, anomalies, and compliance failures as outlined in the Code of Federal Regulations.  Responses include corrective action measures in easy to understand / implement formats!  Gauge your practices, process and procedures!  Get prepared today!

Assuring compliance with 21 CFR regulations requires detailed examination and evaluation across systems, products, process, 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’s Audit objective is to provide an assessment of current compliance readiness based on your Company’s risk assessments during your drug approval process.

Draft audit reports are delivered within 10 business days following the last day of the audit.  Exceptions would be in the case of back-to-back audits where additional time is required.

The Auditing Group Specializing in Auditing, Remediation & Training for:

  • GMP – Good Manufacturing Practice –
    • US Parts 210/211 and Predicate Rules
    • US Parts 110 Food GMPs & 111 Dietary
    • EU, WHO, TGA, JPAL & Canadian GMPs,
    • Facility Audits, APIs, and Finished Goods
    • Mock FDA Audits,
    • Department and Internal Systems,
    • Vendors and Suppliers,
    • Documentation audits,
    • ‘For-cause’ – ‘Due Diligence’ audits. 
    • Standard Operating Procedures,
    • Validation and Compliance Audits.
    • Good Documentation Practice Audits
    • Good Auditing Practices
    • Quality Assurance / Quality Control Audits
    • CAPA, Recall and Complaint Systems
    • Quality Assurance – Quality Control
    • Employee Training, Roles and Responsibilities
    • Asset Tracking, Maintenance and Tech. Services

 

  • GLP – Good Laboratory Practice –
    • US Title 21 FDA CFR  Part 58 GLP
    • US Title 42 FDA Part 493 GLP
    • OECD, EMEA/ICH, Canadian
    • EPA, DEA
    • ISO 17025
    • Tox/Non-Tox Clinical Support Audits,
    • Validation,
    • Life Sciences,
    • Contract Analytical Services,
    • Analytical Equipment,
    • LIMS, Data Transfer, Systems and Software
    • Animal Tagging and Process Systems
    • Deviations, OOS, and CAPA Systems
    • Documentation Audits
    • Calibration Audits.
  • GCP – Good Clinical Practice Audits,
    • Drug, Device and Biologics - Clinical
    • CROs
    • Data Management - Systems
    • Laboratory Support
    • Investigator Sites
    • Database Audits
    •  IND, NDA, ANDA, IDE, PMA/510k, and BLA  Filing Audits
    • Drug Supply Management Audits
    • Training and Support Audits
  • Systems and Part 11 Compliance
    • Systems Audits
    • Software and Part 11 Compliance Audits
    • Good Programming Practice Audits
    • eDC – SAS – Clinical Data Management Systems – ASPs, ISPs, and Data Houses
    • Validation Audits
    • Systems and Validation Audits
    • Network Infrastructure and Systems
    • Security and Compliance
    • 13485/14971 – EU Annex 11 - 15

 

The Auditing Group provides professional consulting and expert implementation assistance to help clients remediate compliance and regulatory issues:

  • Compliance Gap Analysis – GMP, GLP, GCP, & Electronic Systems
  • Validation plan development
  • Education and Training
  • Documentation development
  • Vendor audits
  • Security reviews
  • SOP Development
  • Test plan development and execution
  • Quality Assurance Department Development
  • Development methodology review/evaluation
  • Validation gap analysis
  • Specific Software Evaluation:

 

The Auditing Group Can Also Provide:

  • Validation Consulting Services
  • Clinical Data Management Services
  • Monitoring Services
  • Quality Assurance Services
  • Information Technology Consulting Services
  • Vendor Auditing Services
  • Good Laboratory Audits
  • Good Clinical Practice Audits
  • Clinical Data Audits

Seeking an on-site training seminar for your Company?  The Auditing Group, Inc. provides site specific training on current practices and regulations pertaining to:

  • On-site 21 CFR Part 11 Training Seminars (on-site)
  • On-site 21 CFR Part 820 Training Seminars (on-site)
  • GMP 21 CFR Parts 210/211 Training Seminars (on-site)
  • GCP Training Seminars (on-site)
  • GLP Training Seminars (on-site)

Consulting Services:

  • SOP and Policy Development Services

The Auditing Group can provide comprehensive standard operating procedures (SOPs) according to client specifications;

  • Drug Industry Good Manufacturing Practices (GMPs),
  • Device Industry Good Manufacturing Practices (GMPs),
  • Computer System Validation SDLC, CSVMP, SOPs and Protocol Development
  • 21 CFR Part 11, EU Annex 11 Requirements and Initiatives
  • Good Laboratory Practices (GLPs),
  • Good Clinical Practices (GCPs), ICH GCP, European and US Clinical Trial Regulations.

The Auditing Group can also conduct reviews and updates of existing SOPs to achieve compliance with GXP, and federal regulatory requirements. The Auditing Group SOP development process involves the preparation of a development plan, which is agreed with the client prior to initiating interviews with key staff and the development of process maps.

  • Validation Consulting and Design Execution Services

The Auditing Group consulting service offer s the design, operation, commissioning and validation of various types of high performance facilities, systems and process to ensure your compliance with all GxP standards and regulatory requirements;

  • Facilities
  • Equipment
  • Process
  • Software and Systems

 

  • CAPA Consulting and Design Execution Services

The Auditing Group consulting service offer s the design, implementation, operation, commissioning and validation of various types of Corrective and Preventive Action programs to ensure your compliance with all GxP standards and regulatory requirements.

  • GMP Design/Build Engineering Technical Consulting and Construction Services

The Auditing Group consulting service offer solutions that look at your current GXP challenges in the context of your entire business strategy.

Given the rapidity of change in the bio-pharmaceutical industry, it’s never been more important to make sure that you have access to subject matter experts who can think strategically and, then, act in a targeted fashion.

Fully Integrated Design/Build GXP Engineering and Construction Services

  • Design Drawings and ‘As-Built’ Engineering Drawing Support
  • Asset Management and Data Base Control
  • Facility Operations and Operations Strategies
  • Total Calibration Program Management and Asset Controls

Our engineering and architectural experience encompasses knowledge and understanding of the technical requirements of the GXP industry and of applying new technologies, implementation issues and industry trends. We take pride in our ability to apply our years of experience to offer solutions that optimize cost, minimize risk and improve technical performance.

Our engineering and architectural professionals utilize processes, effective planning and project management tools to offer cost effective business solutions to help achieve the project goals and business objectives of our clients.  


The Auditing Group, Inc.

 

Providing Turn-Key Auditing & Compliance Solutions for Regulated Industry”

GMP, GLP, GCP, 21 CFR Part 11, 820 QSR & 210/211 GMP Compliance Auditing Validation Services and Training Services

GXP Auditing and Remediation / Gap Analysis Services

 

The Auditing Group, Inc. (TAG) has extensive on-site auditing experience for all of the GXP disciplines and requirements, assisting many firms to identify and remediate against minor, major and significant findings which may impact the firm’s ability to compete in today’s regulated industry.

We at TAG emphasize the necessity of not only conducting the on-site audits, but to;

  • Deliver additional detailed reports identifying the risks associated to the findings, and
  • To provide suggestions for remediation and/or resolutions, and,
  • Provide a detailed project Gantt chart as part of the report for remediation Project Management control and oversight.

There are many Auditing firms; however, TAG is more than an auditing firm.  TAG strives   to be your compliance quality partner!

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Gantt Chart:

  • Identify the finding, include risk assessments and priorities based on;
    • Federal Regulations in accordance with local requirements (i.e. FDA, EMEA, etc…)
    • Costs to Remediation / Resolution (CTR)
    • Costs to Manpower / Man-Hour (CMPH)
  • Suggest remediation timelines with milestones
  • Include Predecessors
  • Include Roles and Responsibilities
  • Identification of final deliverables

 


The Audit Certificate Program

TAG offers an Audit Certificate program for companies who are required to provide documented evidence that the Auditee has undergone an appropriate GxP Audit, and has established documented evidence of resolutions to all outstanding GxP compliance issues through a formal remediation program.

Along with the Audit Certificate, the Auditing Group provides additional follow up remediation services at a discount cost to the client to ensure that the remediation initiatives are maintained and that issues are resolved in an appropriate timeframe, based on formal risk assessments.


The Auditing Group, Inc.
Certificate of Audit Compliance

Presented to:

[Company Name]

This Certificate of Audit Compliance issued by The Auditing Group, Inc. confirms that Auditee listed above has formally resolved all compliance issues pertaining to Audit Certificate Number(s) listed below pertaining to;

[insert identification of what/who was audited, i.e., The GxP discipline, The Process, the Systems, if an investigator audit, state  the name of the Principal Investigator; if a Clinical Study Reports (CSR) audit, state the title of the CSR and date of the draft CSR audited.]

Audit Certificate No: [xxxxxx]

Audit Date(s):_________________
[Insert date of final audit report]

 

[Insert Name of Auditor]

 

The Auditing Group, Inc.
PO Box 1696,
Medford, NJ 08055

Senior Compliance Auditor
The Auditing Group, Inc.

 

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