Business Data Solutions & IT Services
IT Process Management.
Structured IT processes as the foundation for GMP-compliant IT systems. We help pharmaceutical and medtech manufacturers set up their IT operational processes in accordance with best practices (ITIL, GxP)—ensuring reliable operations and clear lines of responsibility.
What IT process issues arise in regulated companies?
In the life sciences sector, IT processes are not only important for efficiency—they are critical for compliance:
- Incident management without clear prioritization: GMP-critical IT outages are treated like regular tickets.
- Change management for IT systems operates separately from QMS change control—which leads to dangerous gaps in documentation.
- IT service requests do not follow a defined SLA structure: Users do not know when or how their request will be processed.
- Lack of IT process documentation: During regulatory inspections, critical IT processes often cannot be substantiated.
Are your IT operational processes (incident, change, problem, release) documented in such a way that you can provide evidence of every step during an FDA inspection?
Our IT process management services.
We structure IT operational processes in accordance with recognized ITIL best practices and align them with strict GxP requirements.
IT Process Analysis & Framework Design
Analysis of existing IT operational processes: incident, problem, change, release, and service request management. Gap analysis against ITIL v4 and GxP requirements, as well as the design of a customized framework tailored to the size of your organization.
Incident & Problem Management
Implementation of a GxP-compliant incident process: prioritization matrix with GMP severity levels, escalation procedures, clear documentation requirements, and root cause analyses for incidents with potential GMP implications.
IT Change Management & QMS
Establishment of an IT change management process that is seamlessly integrated into the global QMS change control system. Reliable assessment of GMP relevance and a comprehensive documentation structure for changes to validated systems.
IT Process Documentation (SOPs)
Complete, auditable documentation of all IT operational processes: creation of formal SOPs, work instructions, RACI matrices, and process flowcharts that stand up to any inspection.
Frequently Asked Questions About IT Process Management.
What is ITIL, and why is it relevant to the life sciences?
ITIL (Information Technology Infrastructure Library) is a framework of best practices for IT service management (incident, problem, change, release). In the life sciences sector, ITIL provides a highly proven framework that integrates seamlessly with regulatory GxP requirements (particularly GAMP5 and 21 CFR Part 11).
What is the difference between incident management and problem management?
Incident management aims to restore normal operations as quickly as possible following a disruption (reactive). Problem management, on the other hand, thoroughly investigates the root causes of recurring incidents and resolves them permanently (proactive). In GMP environments, problem management is crucial for preventing recurring compliance failures.
How is IT change management integrated into the QMS change control process?
As a general rule, all IT changes must be assessed for their GMP relevance. Such changes (e.g., to validated systems or database structures) must undergo the formal QMS change control process. IT changes that are not GMP-relevant may remain within the IT department’s own, more streamlined change management process.
Which IT processes are typically reviewed during inspections?
Regulatory authorities often focus on: change management (were all changes to GMP systems implemented in a controlled and documented manner?), backup and recovery processes, access management and authorization policies, incident records for critical incidents, and general system monitoring.
Additional IT & Compliance Services.
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