Industries · Pharma & life sciences
Validated software for pharmaceutical and life science operations
GxP systems must be validated, controlled and demonstrably fit for their intended use. We build and validate laboratory, manufacturing and clinical operations software to a standard that withstands inspection.
Regulatory pressure
Every configuration change, electronic record and signature must be attributable and reproducible. Validation debt accumulates quietly and surfaces at the worst possible moment.
Applicable standards
What we deliver
Computer system validation
Risk-based validation planning, IQ/OQ/PQ protocol authoring and execution, traceability to user requirements and periodic review support.
Laboratory and manufacturing systems
LIMS, ELN, MES and equipment integration engineered for data integrity, audit trails and controlled configuration.
Clinical operations software
eTMF, eCRF and study management tooling built for GCP expectations, with role-based access and complete record history.
Part 11 remediation
Assessment and correction of electronic record and signature controls in systems already in production use.
Documentation set
Evidence delivered with the software
- —Validation master plan and risk assessment
- —User and functional requirement specifications
- —IQ / OQ / PQ protocols and executed reports
- —Traceability matrix and validation summary report
- —Data integrity and audit trail review procedures
- —Change control and periodic review records
Contact
Start with a regulatory gap analysis
Describe the system, the market and the framework you are held to. We reply with an assessment scope, timeline and the documentation you would receive.
General enquiries
hello@softsoft.kzAudit & compliance
compliance@softsoft.kz