ARD Scientific LLC offers an expertise in Compliance Auditing to clients who need to evaluate internal or
vendor processes and quality systems for regulatory compliance.
ARD Scientific LLC utilizes the Client's procedure(s),tools & templates, or a proprietary Compliance
Auditing Procedure, and a set of audit tools & templates.
ARD Scientific LLC guarantees to provide the Audit Report to the Client 5 Business days after the last
audit day.
Types of Audits _____________________________
FDA Good Laboratory Practices (GLPs)
 | | Analytical and Microbiological Testing Laboratories
| | | Animal Studies Facilities
| | | Pre-Clinical Contract Research Organizations (Pre-Clinical CROs)
|
FDA / ICH Good Clinical Practices (GCPs)
| | Clinical Contract Research Organizations (Clinical CROs)
| | | Site Management Organizations (SMOs) and Patient Recruitment Services
| | | Clinical Sites and Phase 1 Clinical Facilities
| | | Central Laboratories, Imaging Service and IVRS providers
| | | Institutional Review Boards (IRBs)
|
Good Manufacturing Practices (cGMPs)
| | Rx, API Facility Inspections
| | | OTC and Personal Care and Nutritional Supplements Facility Inspections
| | | QC Chemistry and Microbiology Laboratories
|
Title 21 CFR Part 11
| | Existing Computer Systems 21 CFR Part 11 and Validation Gap Analysis
| | | Software Vendors Qualification and Software Compliance Assessment
|
ISO 9001:2000 and ISO 17025
| | Pre-Certification Gap Analysis and Quality Systems Audit
| | | Quality Manual and Documents Review
| | | Periodic Internal Audits
|
Audit Tools & Templates ___________________
Pre-Audit Information Request Questionnaires
| | Internal, General Vendor, or Software Vendor
|
Audit Agenda Templates
| | Manufacturing and Laboratory Facilities
| | | CROs, SMOs, IRBs, Clinical Sites, and Phase I Facilities
| | | Software Vendor and /or Software Assessment
| | | ISO 9001:2000 / ISO 17025 Document Review and /or Quality Systems Audit
|
Audit Checklists
| | GLPs: Analytical, Animal or Combinational
| | | GCPs: Clinical CROs, SMOs, IRBs, Clinical Sites, Phase I or Combinational
| | | cGMP Rx, OTC and Personal Care & Nutritional Supplements, API
| | | Software Vendor with or without Software Assessment
| | | ISO 9001:2000 / ISO 17025
|
Audit Report Templates
| | Internal, Vendor, or Combinational with or without Regulatory References
| | | Internal, Vendor, or Combinational with or without Improvement Suggestions
| | | Internal, Vendor, or Combinational with or without detailed description of the Audit Activities
| | | Internal, Vendor, or Combinational with or without compliant processes / records observed
|
Audit Certificate Templates
| | "On behalf of the client"
| | | ARD Scientific LLC 3rd Party Audit "Prepared for the Client"
|
Audit Responses Assessment and Audit Closure Letter Templates |
