Services

Computer System Validation (CSV) & Compliance

📌 Ensuring GxP Compliance for IT Systems
At Qualitice, we specialize in Computer System Validation (CSV) for pharmaceutical and medical device companies, ensuring full compliance with GAMP 5, FDA CFR Part 11, and EU GMP Annex 11. Our team develops risk-based validation strategies, manages documentation, and prepares businesses for audits, ensuring seamless regulatory alignment.

Data Integrity & Risk Management

📌 Data Integrity Gap Assessments & ALCOA+ Compliance
Maintaining data integrity is critical in regulated industries. We conduct data integrity gap assessments, data mapping, and mock audits to help organizations meet the latest FDA, EMA, and MHRA guidelines. Our approach ensures reliable, traceable, and secure data management in compliance with ALCOA+ principles.

GxP Audit Preparation & Quality Management

📌 Regulatory Inspection & Audit Readiness
Qualitice provides expert support in GMP, GCP, GDP, and GLP audit preparation. Our services include mock audits, CAPA implementation, SOP development, and risk assessments, ensuring companies are fully prepared for regulatory inspections and ongoing compliance.

Business Process Optimization & Training

📌 Streamlining Operations & Regulatory Training
Our team helps life science organizations optimize business processes, implement digital solutions, and enhance compliance training. We offer customized training programs on GAMP 5, data integrity, and validation best practices, equipping teams with the knowledge they need to meet regulatory requirements effectively.

Global Project Management for Life Sciences

📌 Managing Complex Regulatory & IT Projects
With extensive experience in global IT harmonization, validation, and compliance projects, Qualitice provides expert project management services. Whether it's SAP rollouts, eDMS implementation, or CRM integration, we ensure efficient execution, risk mitigation, and stakeholder alignment.

Digital Transformation & IT Compliance

📌 Implementing Compliant Digital Solutions in Life Sciences
As the industry moves towards digitalization, we help companies digitize quality processes, implement electronic records & signatures (ERES), and transition to paperless validation. Our expertise includes eDMS, SAP S/4HANA, MES systems, and cloud-based compliance solutions that meet regulatory requirements while increasing efficiency.