GAP ASSESSMENT
A GAP ASSESSMENT is a PROACTIVE approach which can provide an accurate picture to management of the current quality management system. This type of audit can assist in formulating action plans prior to visits from Notified Bodies or Competent Authorities.
INTERNAL AUDITS
INTERNAL AUDITS are a REQUIREMENT for most ISO and Regulatory quality systems. Internal Audits are performed at least annually to internally identify potential compliance gaps. Internal Audits can also be used to assess the effectiveness of process interactions.
SUPPLIER AUDITS
SUPPLIER AUDITS are a REQUIREMENT for most ISO based and Regulatory quality systems. Effectively managing the Supply Chain is crucial to ensure compliance in the Global Marketplace. Assessing and monitoring supplier capabilities and performance can help prevent unwanted surprises and regulatory compliance issues.
DUE DILIGENCE AUDITS
DUE DILIGENCE AUDITS are a must when considering a merger or acquisition. Before signing the agreement, ensure that the quality system and associated records are compliant with quality and regulatory requirements.
Services I Offer
Quality Systems Compliance Inc. provides auditing support including GAP ASSESSMENTS, INTERNAL AUDITS, SUPPLIER AUDITS, and DUE DILIGENCE AUDITS.
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STANDARDS
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ISO 9001 Quality Management Systems - Requirements
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ISO 13485 Medical devices - Quality Management Systems- Requirements for Regulatory Purposes
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ISO 14001 - Environmental management systems — Requirements with guidance for use
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ISO 14971 Medical devices—Application of Risk Management to Medical Devices
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ISO 15378 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
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ISO TS 16949 Quality management systems -- Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations
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ISO 17025 General Requirements for the Competence of Testing and Calibration Laboratories
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ISO 22000 Food Safety Management Systems— Requirements for any Organization in the Food Chain
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STANDARDS
21 CFR Part 4 Regulation of Combination Products
21 CFR Part 11 Electronic Records; Electronic Signatures
21CFR Part 50 Protection of Human Subjects
21 CFR Part 54 Financial Disclosure by Clinical Investigators
21 CFR Part 56 Institutional Review Boards
21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies
21 CFR Part 312 Investigation New Drug Application
21 CFR Part 812 Investigation Device Exemption
21 CFR Part 110 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
21 CFR Part 111 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
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STANDARDS
21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR Part 801 Labeling
21 CFR Part 803 Medical Device Reporting
21 CFR Part 806 Medical Devices; Reports of Corrections and Removals
21 CFR Part 820 Quality System Regulation
21 CFR Part 1270 Human Tissue Intended for Transplantation
21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products
MDD 93/42/EEC Medical Device Directive
CMDR SOR/98-282 Canadian Medical Device Regulations
American Association of Tissue Banks (AATB) Standards for Tissue Banking