Pharmaceutical laboratories, medical device manufacturers, authorized distributors, contract development and manufacturing organizations (CDMO), medical device companies: the pharmaceutical sector in Spain and Portugal operates under a unique regulatory combination — good practices (GxP), validation of computerized systems, national authorities (AEMPS, INFARMED) and European (EMA), and ISO 13485 standards for devices. Operations are complicated by the need to not stop production or break the cold chain.
Impulso Tecnológico works with Iberian pharmaceutical labs and medical device companies for over 15 years. We know the demands: 21 CFR Part 11 / GAMP 5 validation, documented change control, computerized systems that must survive AEMPS audits, cold chain that can't break.
Typical challenges in pharma
- Unvalidated computerized systems: ERPs, MES, LIMS, EMS — all must be validated per GAMP 5. AEMPS can request evidence in any inspection.
- 21 CFR Part 11 (FDA) if exporting to USA: electronic records, electronic signatures, complete audit trail, access controls.
- ISO 13485 for medical devices: specific quality management, design documentation, post-market surveillance.
- Cold chain with no tolerance: any break requires documentation, investigation and sometimes batch destruction.
- 24/7 production: no critical system can have unplanned downtime. Stops are scheduled months in advance.
- Constant audits: AEMPS, EMA, FDA, corporate clients, ISO certifiers. Each demands its type of evidence.
How we tackle it at Impulso
- Validation of computerized systems: URS, FS, DS, IQ, OQ, PQ documentation for each system (ERP, LIMS, MES, etc.). Initial validation plan + periodic revalidation + change plan.
- 21 CFR Part 11 when applicable: audit trail configuration, electronic signatures with MFA, role-based access controls, retention per policy.
- ISO 13485 documentation: document management with approval flows, documented training, non-conformance management.
- Cold chain monitoring: IoT sensors integrated with central system, real-time alerts, immutable log, automatic reporting.
- Pharmaceutical cybersecurity with Fortinet + Sophos: segmentation between office and production networks, mandatory MFA, 24/7 monitoring, Veeam immutable backup.
- 24/7 support with critical SLA: <15 min response for production incidents, vendor escalation, client portal with all incidents.
Iberian pharma regulatory framework
- Good Practices (GxP): GMP (manufacturing), GDP (distribution), GLP (laboratory), GCP (clinical). Applicable per activity.
- GAMP 5: validation of computerized systems. De facto standard in pharma.
- 21 CFR Part 11 (FDA): electronic records and signatures if exporting to USA.
- ISO 13485: quality management for medical devices. Distinct from ISO 9001.
- EU Regulation 2017/745 (MDR): medical product regulation. Post-market surveillance.
- GDPR + LOPDGDD: clinical trial data as special category.
- NIS2: mid-sized labs in critical sectors (manufacturing) are essential.
Why Impulso for Iberian pharma
- Real GxP experience: we have validated ERPs, LIMS and MES at Iberian pharma clients. We know what documentation each audit asks for.
- On-site coverage: dispatch to a plant or lab in Spain or Portugal in under 4 hours for critical incidents.
- Zero stops during intervention: every plan is coordinated with production and quality to avoid unplanned windows.
- Partner Microsoft, Fortinet, Sophos, Veeam: consolidated stack with GxP experience.
If your pharmaceutical lab or medical device company needs to validate systems, prepare an AEMPS inspection, or reinforce cybersecurity without stopping production, we offer a free initial assessment: visit, executive diagnosis, prioritized plan within two weeks.