Integrated Solutions & Outsourcing Group
ISO Group's aim is to support develop, implement and maintain regulated requirements that meet intended purposes and are fully compliant with all applicable FDA and US regulations, and your internal quality standards. Our high skilled personnel ensure that your project succeeds on schedule and within budget.
ISO Group provides extensive experience and knowledge in compliance of pharmaceutical and medial devices plant operations.
Regulatory Compliance / Validation
Functional requirements specifications
Factory acceptance tests(FAT)
Site acceptance test (SAT)
Validation Master Plans
Commissioning and Qualifications, Start Up
Facilities, Utilities, Manufacturing, Packaging equipment qualification
Installation, operational, performance qualification protocols and Reports
Computer Systems Validation(SDLC)
Process validation and Investigations
Cleaning validation
Environmental Monitoring Programs
CAPA Support
FDA Regulations Assessment
Laboratory Systems Validation
Risk Management Consulting
SOP Development
Vendor assessments
Project Management
Small Capital Projects
Client Representative. for Large Projects
Engineering Support Services
Design Engineering
Drafting Services
CMMS support
MRO Integrators
Technical Staffing
Instrumentation
As-Built drawing Generation
Facilities Management
Photovoltaic System Maintenance
Facilities
Utilities Maintenance