IT departments in FDA regulated companies have a special challenge when it comes to IT GxP. These departments require not only IT technical expertise, but also GxP experts to lead the way through challenges like vendor and supplier management, retirement of systems, managing deviations and CAPA, qualification and validation, risk assessment, data integrity, 21 CFR Part 11 compliance, change control, security and other GxP required functionality. The foundation of GxP IT Quality is risk assessment and risk management incorporated into an efficient SDLC. Globiox-developed System Development Life Cycles (SDLC) are used by major pharmaceutical companies and have been embraced by technical IT staff, project managers, Quality Assurance, and Senior IT leaders. Globiox’s methodology closely aligns Business Requirements with Technical Specifications and Design Specifications to provide outcomes that meet the business needs in a cost-effective and efficient manner. And project managers love it because there is consistency among projects, making timelines and budgets easier to establish and meet.
The risk assessment methodology is streamlined, automated, and is linked to deliverables suggested with each level of risk. It allows the team to really focus on the deliverables required to mitigate the most important risks. Our services include:
- System Development Life Cycle (SDLC)
- Vendor/Supplier management
- Retirement of Systems
- Deviations and CAPA
- Risk Assessment and Management
- Qualification and Validation
- Data Integrity
- 21 CFR Part 11 Compliance
- Security Assessment