Remediation Starts with Good Project Management (GPM) Compliance!

Strict adherence to GPM is essential to ensure all tasks are completed in accordance with formal written procedures and attention to meeting timelines.

All SMEs have the training, education, background and training to ensure that your remediation efforts are within industry standards and satisfy Agency requirements.

All remediation projects are managed by a 'dedicated' CAPA Manager, utilizing The Auditing Group validated CAPA Management Software and through strict Gantt task management software.

Timeline meetings are arranged based upon risk, and all reports are issued on a weekly or if required, daily basis.

  • FDA/EMA/ISO Observations, 483s and Warning Observation Resolutions

  • Procedure Development

  • Validation Services

  • Training

  • Quality Management Systems

  • GMP Design / Build Analysis

  • As-Built Drawing Management Services

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Let CAPA Management oversee your CAPA program with our Experienced CAPA Managers and our 21 CFR Part 11 Compliant CAPA Management Software.

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Task Driven Gantt Charts

Audit Observations and
FDA 483/Warnings

  • Assisting Companies in remediation of agency observations and warnings through quality Project Management Practices and process geared towards meeting timelines through successful resolutions.

Quality Management Systems Implementation

  • QMS Audits and Assessments

  • QMS Readiness and Systems Evaluation

  • QMS Project Planning and Implementation Support

  • Turn-key QMS Services

Validation Services

  • The Validation Group provides validation services supporting.

  • Process Validation

  • Equipment Validation

  • Software and Systems

  • Facility Qualifications

  • Validation Procedures

  • Method Validation

Training Programs

Offering GxP training through GMP Boot Camps.

  • GMP Training

  • GLP Training

  • GCP Training

  • ISO Training

1, 2, or 3-day On Site and Virtual programs available

Protocols and Procedure Development

  • With over 30 years of procedure writing, TAG has to most extensive library of procedures for any type of industry, process or system.

  • Turn-key implementation services available!

CAPA Management

CAPA Management Services offers CAPA Project Management Support so you can feel confident that your tasks are completed on-time!