Quality Systems, Compliance and Engineering
The critical question facing many companies today is how to bridge the gaps between U.S. FDA's revised quality system regulations (QSR) covering good manufacturing practices and their own internal Corporate Standards. Ongoing developments in a changing regulatory environment, along with changes in the global regulatory marketplace are part of a trend toward harmonization of regulatory processes and requirements designed to eliminate trade barriers.
Experienced ATC staff members are trained to review and consult on existing systems and procedures to improve processes, upgrade systems to new specifications, or to prepare for regulatory review and compliance audits.
Quality System Design and Introduction
ATC Corporation of Indianapolis professionals possess the knowledge required to develop a program that conforms with the FDA's Quality System regulation.
Quality components are currently among the FDA’s most critically inspected systems.
ATC Provides a review of key issues relating to quality systems including:
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Quality Systems Definition
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A listing of FDA Quality System Inspection Items
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Comparative survey between current GMP regulations and your Corporate documentation
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Initiation of Quality Systems Structure [for new companies or newly compliant companies]
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Leveraging the revised guidance documents for fewer and shorter FDA inspections
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Required documentation for a Quality Systems
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Auditing or reviewing a Quality Systems in preparation for FDA inspections
Quality System Gap Assessments
A gap analysis gives detailed information on what elements of a system are already completely or partially present in your organization, and thus what remains to be done. Gap analyses are available for organizations interested in implementing a basic system, an intermediate system, or a full system of regulatory compliance measures. Results can be used in the planning of future actions.
Organizations interested in fully conforming should request a pre-assessment audit from ATC. Experienced auditors will conduct an audit conducted in a style similar to that of the FDA. Any deficiencies in the system can then be resolved.
ATC provides three levels of assessment:
A Level 1 Assessment is a walk-through audit using visual inspection and resulting in a listing of potential savings opportunities.
A Level 2 Assessment uses data measurement and appropriate software tools to prepare an inventory and results in a written report with recommendations for actions and a cost/benefit analysis.
A Level 3 Assessment is an investment-grade audit, involving detailed monitoring and measuring and extensive costs and risk analysis. Assessments are available for:
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Computer Systems
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Facilities [General or Specific System]
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Analytical/Methods
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Equipment [Packaging/Process]
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Products [Systems Support/Operation/Release]
CAPA Program Design and Implementation
Successful implementation of Corrective And Preventive Action (CAPA) is highly dependent upon the effectiveness of the planning that goes into it.
The following describes twenty (20) major tasks that the ATC Corporation of Indianapolis project team considers when developing a project plan. Let us develop one for your organization.
ATC Corporation of Indianapolis delivers a plan with:
A Preparation Phase including:
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Formation and Training of Project Teams
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Research and Analysis of Issues and Development an “As Is” Process Flow Diagrams
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Development of Project Scope, Alternatives, Assumptions, Obstacles, and Costs
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Development of Comprehensive, Structured Communication Plans
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Status Review Preparation and Presentation in a Milestone Format
A Design Phase including:
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Development a “To Be” Process Flow Diagram
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Review of Existing Policies and Procedures
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Development New Policies, Procedures and Architecture
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Establishment of Performance Metrics for Required Systems
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Confirmation Design with Subject Matter Experts
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Milestone: Status Review Preparation and Presentation
An Implementation Phase including:
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Obtaining Approvals of New Procedures
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Development An Implementation Plan
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Process Through Change Control and Document Control Systems
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Conducting General Awareness and Specific Job Training
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Milestone: Perform an Internal Audit to Confirm The New System is In Place and In Use
A Verification Phase including:
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Assembling the verification document
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Conducting the internal review and approvals of the verification document
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Defending the verification document with third-party reviewers, as applicable
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Milestone: file project documents and schedule internal audit
