Regulated IT and validation
Regulated technology demands a different level of discipline. SW33R's leadership brings years of experience from validation work in complex pharmaceutical production environments, including one of the world's largest pharmaceutical manufacturers. We bring that experience to organisations in Dubai and across the GCC that need systems, evidence and decisions designed with validation and inspection readiness in mind.
For pharma manufacturers and distributors, medical device companies, laboratories, CROs and healthcare groups in the UAE and GCC that answer to MOHAP, DHA, EMA or FDA.
- Strategy
- Validation master plans, risk-based approach, system inventories and periodic review
- Execution
- URS, FS, DS, IQ, OQ, PQ, traceability and summary reports, with complete documentation and traceability
- Data integrity
- ALCOA+ assessments, audit trail review, remediation programmes
- Cloud and vendors
- Qualification of SaaS and cloud providers for regulated workloads
- Inspection support
- Audit readiness, mock inspections, findings closure
- Compliant software
- Building new systems that are validatable by design, so compliance is not a retrofit
Have something in mind? Let's figure out what it should become.
No pitch deck required. You do not need to know what the solution is yet. Tell us where you are and what you are trying to achieve. We will tell you honestly whether we can help, and what we would look at first.
English, Arabic or Danish. Your choice.