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 (en

📌 Pharma IT Applications (España)
🏢 Novacomp
📍 España