American Technical Consultants
When Direction Matters
Compliance Auditing
Compliance Auditing
ATC offers:
ATC delivers:
Simulated Pre-approval Inspections
ATC presentations comprise:
Vendor Audits
ATC auditors provide:
Audit plans and reports in compliance with your organization’s corporate policies.
Due Diligence Audits
ATC delivers:
ATC delivers:
Conducting supplier audits is a critical part of helping your company to stay in compliance and ensure that your products will meet today’s changing requirements.
ATC offers:
- Comprehensive vendor, facility and documentation quality audits
- Independent QS Regulation and Good Manufacturing Practice [GMP] audits
- Good Laboratory Practice [GLP] audits
- Simulated pre-approval inspections
- Design control audits
- Software quality audits
- Electronic Records/Electronic Signatures [21 CFR Part 11] compliance audits and actions plans
- Internal audit training
ATC delivers:
- Detailed inspection reports which include regulatory references, as applicable.
- A recommendation package with an emphasis on prioritization of Corrective Action steps.
- A separate EIR style overview, unique to the compliance industry.
- Development of a formal plan based on audit findings to implement with your staff or site.
Simulated Pre-approval Inspections
Practice makes perfect and being prepared is the most overlooked step in the drug submission process.
ATC’s personnel are qualified in the preparation and presentation of drug submission packages and can assist your organization understanding FDA requirements. for the manufacture of clinical trial material and product development activities.
ATC presentations comprise:
- What the FDA will look for during the conduction of a PAI inspection.
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Specific areas of inspection areas, such as:
- Stability
- Validation
- Training
- Scale-Up
- Technology Transfer
- An outline of potential short- and long-term strategies for successful pre-approval inspections;
- Describe how best to manage inspection processes;
- Provide strategies for minimizing FDA-483 observations;
- Detail the specific consequences of failing the pre-approved inspection;
- Explore how to respond to FDA-483 comments;
- Minimize the number of inspections conducted by the FDA.
Vendor Audits
Audits are an essential quality tool for verifying compliance, good practices and progress.
Efficient, effective outsourcing. One description of how ATC’s ASQC certified auditing staff can act as an extension of your organization’s own auditing group conducting both internal, contract manufacturing and laboratory audits.
ATC auditors provide:
The planning, organization and execution of cGMP and EU Regulatory Compliance audits for your organization’s commercial sites, related contractors and potential business acquisitions worldwide.
Audit plans and reports in compliance with your organization’s corporate policies.
Recommended corrective action plans in relation to their audit findings; can negotiate appropriate courses of action with your organization clients; and perform the follow-up review and evaluation of ensuing actions.
Due Diligence Audits
Our staff combines managerial expertise, technical capabilities and common-sense financial and business knowledge to provide comprehensive consulting services to assist our clients in meeting their objectives.
ATC delivers:
- Technical Audits:
- Comparison to industry norms
- Problem analysis and solutions
- Operation & maintenance training
- Recommendations for improvements
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Expert Witness:
- World-class Expert Witnesses are available with experience in Quality Systems, Validation Systems, Project Management and cGMP Training.
The guidelines for Computer Validation have recently changed. Is your organization prepared?
Software Quality Assurance [SQA] is a planned and systematic approach to ensure that software process and products conform to the established standards, processes and procedures outlined in 21 CFR Part 11. The goals of SQA are to improve software quality by appropriately monitoring both software and the development process to ensure full compliance with the established standards and procedures.
ATC has the required expertise to implement a Software Quality Assurance program for your organization. Our consultants will access and audit your system for the critical items listed below to assure your compliance with today’s 21 CFR Part 11 requirements.
ATC delivers:
- Life-Cycle Development
- Software Testing
- Software Operation And Maintenance
- Software/Hardware Configuration Management
- Software Error Control And Corrective Actions
- Software Dedication
- Software/Hardware Procurement
- Data Management And Control
- Embedded Software And Firmware Control
