A robust Quality Management System (QMS/e-QMS/GMP) is the foundation of regulatory compliance, product safety, and risk mitigation across the Medical Device, In Vitro Diagnostic (IVD), and Pharmaceutical industries to protect end-user health and patient lives.

SRAMS considers "Patient safety is Utmost priority" and helps manufacturers with compliance with below services. 

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Services: 

• Quality Management System (QMS) Establishment

• ISO 13485, QMSR and GMP Gap Assessment & Roadmap

• Process Installation, Qualification and Validation

• Internal Audits, Supplier Audits & Regulatory Mock Inspections

• Quality Documents (Quality Procedures, SOPs, WI's) Creation.

• Change Controls and CAPA Management.  

• e-QMS Validation