About QICS

QUALITY INTEGRITY CHECK SOLUTION (QICS) is a South African-based consultancy dedicated to advancing compliance and excellence across the manufacturing, pharmaceutical, medical device, and life sciences sectors.

travel, darling, architecture, outdoors, horizontal, tourism, panoramic, sun, business, building, blue sky, industry, job, clouds, metallurgical, blue, technology, detail, nature, sky blue, companies, money, banks, reflection, new, modern, museum, street, city, large, perspective, contracts, progress, audit, auditor, logistics, contact, presentation, economy
We specialize in Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP), Good Pharmacovigilance Practice (GVP), ISO 45001:2018 Occupational Health & Safety Management Systems, ISO 9001:2015 Quality Management Systems, training and awareness programs, independent quality compliance investigations, corrective and preventive action (CAPA) management, change control mangement and audit services. Founded by Sithabile Kapoyi, a seasoned Lead Auditor, Trainer, and Quality Management Systems specialist with over 17 years of experience, QICS brings unmatched expertise in navigating diverse regulatory frameworks, having conducted international GxP audits across Africa, Asia, and Europe. Driven by a commitment to excellence, integrity, precision, and alignment with global standards, QICS delivers world-class compliance solutions that foster transparency, accountability, and operational resilience.

Social Impact

QICS supports community development through volunteer work with Abalindi Welfare Society, promoting holistic youth empowerment and mental health awareness.

Leadership

Sithabile Kapoyi: Founder, Lead Auditor, Trainer, and Quality Management Specialist.

Academic Foundation:

Sithabile Kapoyi holds a BSc in Microbial Biotechnology and a BTech in Quality Management, combining scientific expertise with advanced quality systems knowledge. In addition, she has successfully completed the Post Basic Pharmacist’s Assistant course and is registered with the South African Pharmacy Council, further strengthening her pharmaceutical and Quality Assurance and regulatory insight. She also holds a Train-the-Trainer certificate (ETDP SETA), enabling her to design and deliver accredited training programs that build organizational competence and compliance culture.

Professional Certifications:

  • CQI and IRCA certified ISO 9001:2015 Lead Auditor training course – internationally recognized qualification for conducting clause-by-clause QMS audits.
  • ISO 13485 Internal Audit training certificate – specialized in medical device quality management systems.
  • ISO 14001:2015 and OHSAS 18001:2007 Internal Audit training certificate – expertise in environmental and occupational health & safety audits.
  • GMP Internal Audit training certificate – focused on pharmaceutical manufacturing and laboratory compliance.
  • GMP Auditor – extensive experience in sterile/non-sterile manufacturing, APIs, excipients, packaging, and distribution.
  • GMP (Good Manufacturing Practice) training certificate – reinforcing knowledge of pharmaceutical quality systems.
  • Advanced Pharmacovigilance (PV) Audits and Inspections – specialized in post-market drug safety monitoring and compliance.
  • Risk and System Impact Assessment training certificate – skilled in evaluating operational risks and system vulnerabilities.
  • Root Cause Analysis training certificate – expertise in structured problem-solving and CAPA effectiveness verification.

Regulatory Expertise

Extensive hands-on experience with SAHPRA, WHO, EU GMP, PIC/S, FDA (21 CFR), and ISO frameworks, enabling organizations to meet diverse international regulatory requirements.

Audit & Compliance Track Record

  • Proven success in audit execution, covering internal audits, vendor audits, and outsourced activity assessments.
  • Skilled in CAPA oversight, ensuring corrective and preventive actions are properly investigated, documented, and verified for effectiveness.
  • Delivery of regulatory training programs that strengthen organizational competence and inspection readiness.

    • Systems Implementation & Integration

    • Expertise in gap analysis to identify compliance weaknesses and design risk-based improvement strategies.
    • Development of integrated management systems that harmonize ISO and GxP standards for efficiency and sustainability.
    • Guidance on documentation frameworks, audit trails, and regulatory referencing to support inspection transparency.
    • Implementation of structured change management frameworks that align with Quality Management System processes, ensuring smooth adoption of new standards, minimizing disruption, and embedding resilience and adaptability across the organization.

    International Experience

  • Conducted Good Practices (GxP) audits across Africa, Asia, and Europe, providing deep insight into cross-border regulatory expectations and operational diversity.
  • Enhanced global compliance strategies by adapting methodologies to varied cultural, regulatory, and industry contexts.

    • Transform Your Compliance Today

    Contact us to learn how our comprehensive quality assurance services can enhance your operational integrity and compliance.
    Contact Us
    Scroll to Top