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.
We approach pharma and the pharmaceutical industry projects from the actual environment, its dependencies and the priorities agreed with the client. Scope is confirmed after reviewing locations, systems, access, risks and owners.
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.
- Defined coverage and escalation: service hours, priorities, response targets and third-party escalation are agreed per engagement; permanent availability or a fixed nationwide response is not assumed.
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 scope to be validated: applicability, category, obligations and dates are checked against current official rules based on activity, size, country and supply-chain role; the legal or compliance team owns the legal determination.
Why Impulso for Iberian pharma
- Case-by-case on-site coverage: our own team is based in Madrid and, elsewhere in Spain and Portugal, the suitable local resource or nearest available partner is assigned after location, resource, timing, scope and access are confirmed for each request.
- Zero stops during intervention: every plan is coordinated with production and quality to avoid unplanned windows.
- Technology matched to the environment: vendors, licences, integrations and capabilities are validated during design; any certification or contractual requirement is confirmed before it enters a proposal.
How to prepare an IT decision in pharma and the pharmaceutical industry
A useful assessment starts with an operational map: sites, users, applications, equipment, vendors, change windows and owners. In pharma and the pharmaceutical industry, the priority is to understand validation, change control and documented continuity; a product list without that context cannot support a comparable option or a realistic scope.
The inventory links each computerised system to its intended use, owner, data, interfaces, validation state and change record. GxP relevance is determined with quality; mentioning a platform or regulation does not by itself define the validation deliverables.
A representative test follows an approved requirement through execution, evidence, review and exception handling. Production, laboratory and cold-chain stakeholders agree the window and acceptance criteria before a controlled system is changed.
Handover preserves versions, approvals, deviations, restoration evidence and remaining actions. Technical work supports the quality system but does not replace the manufacturer, quality unit or regulatory authority responsible for a decision.
Documentation remains useful through a visible date, version and owner. Assumptions that have not yet been verified stay marked as assumptions and do not become commercial commitments.
Handover records results, exceptions, relevant configuration, tests and subsequent controls. This lets the internal team distinguish a completed improvement from an outstanding dependency and measure the service against data agreed for its environment.
If you need to review this area in pharma and the pharmaceutical industry, we can first validate locations, systems, priorities, access and available evidence. That information supports a realistic scope, ownership model and next steps.