ICCON Global Consultancy
ICCON International Compliance Consulting is an international company providing validation, qualification, engineering, and training consulting services to pharmaceutical, veterinary, and medical device companies worldwide. With over 15 years of experience, they focus on data integrity, risk-based validation, and compliance with global regulatory standards, helping clients ensure the integrity, reliability, and availability of their regulated records to support quality production and patient safety.
Industries
Nr. of Employees
small (1-50)
ICCON Global Consultancy
Products
Validation and qualification project examples
Completed project types include validation of laboratory instruments, chromatography data systems, LIMS, cloud-hosted systems, manufacturing control systems, ERP and track & trace implementations, environmental monitoring and validated spreadsheets.
Validation and qualification project examples
Completed project types include validation of laboratory instruments, chromatography data systems, LIMS, cloud-hosted systems, manufacturing control systems, ERP and track & trace implementations, environmental monitoring and validated spreadsheets.
Services
Full lifecycle validation services for regulated computerized systems including validation planning, URS/FS development, IQ/OQ/PQ protocol generation and test execution.
Assessment of data integrity risks, ALCOA/ALCOA+ assessments, tailored audit checklists, friendly audits, and remediation strategies including training and implementation support.
CSV and GMP audit services covering procedures, validation documentation, operational activities and records; periodic reviews to maintain validated state and pre-inspection preparation.
Qualification and verification of laboratory instruments according to USP/AIQ principles, including strategy development and execution of qualification documentation.
Project management covering system selection, procurement advice, FAT/SAT coordination, network infrastructure design and oversight of validation activities during implementation.
On-site and remote trainings covering CSV fundamentals, GAMP5 risk-based validation, Part 11/Annex 11 assessments, audit trail auditing and data integrity in GxP records.
Full lifecycle validation services for regulated computerized systems including validation planning, URS/FS development, IQ/OQ/PQ protocol generation and test execution.
Assessment of data integrity risks, ALCOA/ALCOA+ assessments, tailored audit checklists, friendly audits, and remediation strategies including training and implementation support.
CSV and GMP audit services covering procedures, validation documentation, operational activities and records; periodic reviews to maintain validated state and pre-inspection preparation.
Qualification and verification of laboratory instruments according to USP/AIQ principles, including strategy development and execution of qualification documentation.
Project management covering system selection, procurement advice, FAT/SAT coordination, network infrastructure design and oversight of validation activities during implementation.
On-site and remote trainings covering CSV fundamentals, GAMP5 risk-based validation, Part 11/Annex 11 assessments, audit trail auditing and data integrity in GxP records.
Expertise Areas
- Computerized system validation (CSV) for GxP systems
- Data integrity governance and ALCOA/ALCOA+ assessments
- Regulatory compliance for electronic records (21 CFR Part 11, EU Annex 11, PIC/S)
- Analytical instrument qualification (AIQ/USP)
Key Technologies
- Laboratory Information Management Systems (LIMS)
- Chromatography Data Systems (CDS)
- Scientific Data Management Systems (SDMS)
- Supervisory Control and Data Acquisition (SCADA)
News & Updates
Our online validation and data integrity trainings start in February, redesigned to meet your needs.
Presented seminars on computerized systems validation and data integrity at the Bioexpo fair in Istanbul.
Explained risk-based GAMP 5 approach in validation activities to ensure data integrity and security.
Discussed computerized systems validation and data integrity with participants at the fair.
Workshops on risk-based validation approaches for laboratory and production systems.
15 Years of Experience in Data Integrity & Validation Services
Over 15 years of providing validation, data integrity, and qualification services.
Our online validation and data integrity trainings start in February, redesigned to meet your needs.
Presented seminars on computerized systems validation and data integrity at the Bioexpo fair in Istanbul.
Explained risk-based GAMP 5 approach in validation activities to ensure data integrity and security.
Discussed computerized systems validation and data integrity with participants at the fair.
Workshops on risk-based validation approaches for laboratory and production systems.
15 Years of Experience in Data Integrity & Validation Services
Over 15 years of providing validation, data integrity, and qualification services.