Steel Horizon provides a portfolio of specialized services, each supported by standardized tools and risk-based approaches.
Core Services:
- Validation & Qualification: IQ/OQ/PQ, process validation, cleaning validation, utility/equipment qualification.
- Regulatory Compliance Investigations: Root cause analysis, CAPA development, FDA/EU warning letter responses.
- Training & SOP Development (employee coaching): Tailored compliance workshops, technical writing, in house staff coaching.
- Staff Augmentation: Deployment of skilled validation engineers, quality specialists, and investigators on contract basis.
Methodology:
- Standardized Templates mapped to FDA and EMA guidance.
- Risk-Based Prioritization using FMEA to focus resources on high-impact issues.
- Data Integrity by Design embedding ALCOA+ principles in all documentation.
- Milestone-Based Delivery ensuring clients can demonstrate progress at every inspection stage.