ComplianceLogix
ComplianceLogix is a Contract Quality Organization (CQO) that provides regulatory compliance training and quality assurance consulting services for pharmaceutical, biotechnology, and clinical research organizations. Founded in 2009, it maintains a global network of industry experienced consultants supporting client activities worldwide. Their services include GCP, GLP, and cGMP training, quality assurance audits, compliance training, clinical audits, vendor audits, batch record review, SOP writing, computer system validation, and quality systems implementation. The company aims to support the development of innovative and life-saving therapeutics through comprehensive quality and compliance solutions.
Industries
Nr. of Employees
small (1-50)
ComplianceLogix
Saint Petersburg, Florida, United States, North America
Services
Consulting engagements to design, implement and improve quality systems, perform QA program assessments, and develop SOPs and procedural documentation for regulated organizations.
Independent audits including planning, document review, on-site or remote execution, exit interviews and audit reporting for investigator sites, CROs, vendors and manufacturing facilities.
Validation planning and execution for computerized systems used in production and quality processes, applying risk-based software assurance and documentation strategies to meet regulatory requirements.
Courses and training programs covering GCP, GLP, cGMP, SOP training, inspection preparedness and other compliance topics delivered online or in-person.
Consulting engagements to design, implement and improve quality systems, perform QA program assessments, and develop SOPs and procedural documentation for regulated organizations.
Independent audits including planning, document review, on-site or remote execution, exit interviews and audit reporting for investigator sites, CROs, vendors and manufacturing facilities.
Validation planning and execution for computerized systems used in production and quality processes, applying risk-based software assurance and documentation strategies to meet regulatory requirements.
Courses and training programs covering GCP, GLP, cGMP, SOP training, inspection preparedness and other compliance topics delivered online or in-person.
Expertise Areas
- Clinical quality assurance and site auditing
- Regulatory compliance (GCP, GLP, cGMP)
- Quality systems design and implementation
- Computer system validation and software assurance
Key Technologies
- Videoconferencing and live remote tour platforms
- Secure document management and file-sharing systems
- Electronic informed consent (eConsent) platforms
- Electronic records and electronic signatures compliance (21 CFR Part 11)
News & Updates
FDA issued a guidance on voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, compounded, or held, during the COVID-19 pandemic.
FDA issued guidance on how to conduct clinical trials during the COVID-19 public health emergency, including remote monitoring and virtual visits.
Draft guidance providing recommendations on computer software assurance for systems used in medical device production and quality systems.
FDA addresses inquiries related to GCP and human subject protection policies, providing a downloadable spreadsheet of responses from 2017 to 2021.
FDA guidance clarifying the impact of the 2018 HHS Common Rule provisions on FDA-regulated clinical investigations.
FDA issued a guidance on voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, compounded, or held, during the COVID-19 pandemic.
FDA issued guidance on how to conduct clinical trials during the COVID-19 public health emergency, including remote monitoring and virtual visits.
Draft guidance providing recommendations on computer software assurance for systems used in medical device production and quality systems.
FDA addresses inquiries related to GCP and human subject protection policies, providing a downloadable spreadsheet of responses from 2017 to 2021.
FDA guidance clarifying the impact of the 2018 HHS Common Rule provisions on FDA-regulated clinical investigations.