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Factory Capability & Capacity Audit
(FCCA Audits)

Does your CMO or Facility have the Capabilities to support your requirements,
or the Capacity of existing operations to support your needs?

  • Basic GMP QMS QSR ISO Concepts and Practices

  • Review of current Quality Management System practices, programs and policies

  • Standard Operating Procedures, Work Instructions, Policies and Practices

  • Device Master Record (DMR)

  • Device History Records (DHR) or Assembly Records

  • Design History File (DHF)

  • Interviews with key staff

  • Quality Assurance Process and Practice Reviews

  • Quality Manual / Quality Management System Review

  • CV Review, Job descriptions, Organizational charts, Roles and Responsibilities

  • Training records, curriculums and Training programs

  • Quality Control Program

  • Internal Audit Procedures and Reports

  • Vendor/Supplier Qualification/Inspections/Audits

  • Document Control and Management Processes

  • Past / Previous Audit Reports (3rd Party/Internal/Agency)

  • Network Infrastructure and Systems Management/Security Procedures

  • Facilities including physical inspections

  • Engineering, Maintenance, Metrology, Janitorial and Facilities

  • Equipment/Instrumentation; Qualification/Validation/Calibration/Maintenance

  • Asset Management

  • Site Qualifications/Facility Qualifications, Basis of Designs (BOD) and Site Master Plans.

  • Asset Management

  • Site Qualifications/Facility Qualifications, Basis of Designs (BOD) and Site Master Plans.

  • Change/Process Controls

  • Quality Technical Agreements

  • Corrective and Preventative action programs (CAPA, Facilities and Systems)

  • Non-Conformance, Out of Specifications Practices

  • Deviation reports/QA reports

  • Batch Records/Production Record Review (Masters and In-Process)

  • Report preparation/review/approval/revision

  • Document Control / Document Management

  • Archival system and Record retention program

  • Process/Equipment/Facility/Systems Validation and Qualification

  • Methods Development, Transfer Validation

  • Preparation and Tracking of Standards

  • Accuracy and Precision of Data Entry Qualifications

  • Tracking Analytical Results and Compliance (GLP Audits)

  • Acceptance and Rejection Criteria

  • Retest/Repeat Analysis

  • Test and Control Article Chain of Custody (GLP/Clinical)

  • Water System, Waste Systems and Facility Utility Qualification/Validation

  • Environmental Systems Monitoring / Building Monitoring Systems

  • Specimen/Sample/Collection Receipt/Identification/Handling/Documentation (GLP/GCP)

  • Data collection/verification/management (GLP/GMP and GCP)

  • Computerized Systems in support of GxP activities

  • 21 CFR Part 11 Compliance

  • Computer Systems Validation and Qualification

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