Pharma IT Applications (R&D; & Clinical)
Experience supporting and improving IT applications used in the pharmaceutical industry, both in research laboratories (R&D; – Research & Development) and in clinical processes (such as clinical trials involving patients).
These systems operate under strict regulatory requirements (GxP/GAMP5), meaning that all activities (usage, changes, data handling) must be controlled, documented, and auditable.
? Laboratory Systems
Hands-on experience with systems commonly used in laboratories:
LIMS (Laboratory Information Management System): software used to manage laboratory samples, test results, and associated data
ELN (Electronic Lab Notebook): a digital notebook where researchers document experiments and findings
CDS (Chromatography Data System): software used to collect and analyze data from laboratory instruments (e.g., chromatography equipment)
Typical responsibilities include:
User support
Incident resolution
System maintenance and enhancements
? Clinical & Regulatory Processes




Understanding of processes related to clinical studies and regulatory compliance:
Clinical workflows: how clinical trials are managed (patient data, study tracking, data collection)
Pharmacovigilance: systems used to monitor the safety of drugs, including tracking adverse effects
Regulatory tools: applications used to ensure compliance with health authority requirements
The main goal is to ensure that all processes comply with strict pharmaceutical regulations.
? GxP Compliance & Validation
Experience working under regulated quality standards:
GxP (Good “x” Practices): a set of regulations designed to ensure product quality, safety, and data integrity (e.g., GCP, GMP, GLP)
GAMP5: a framework for validating computerized systems in regulated environments
This includes:
System validation (ensuring systems work as intended and meet requirements)
Change control (managing and documenting system changes)
Quality assurance (ensuring compliance and audit readiness)

📌 Pharma IT Applications (España)
🏢 Novacomp
📍 España