OUR EXPERTISE

ISO Group provides expertise identifying problems and suggesting cost effective solutions to our clients. Each methodology and/or framework is tailored in support of our client’s specific regulatory and business environment.

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 biopharmaceutical and medial devices plant operations.BIO

COMMISSIONING, QUALIFICATION, and VALIDATION

  • CAPA Support

  • Factory acceptance tests(FAT)

  • Site acceptance test (SAT)

  • Validation Master Plans

  • Cleaning validation

  • Laboratory Systems Validation

  • SOP Development

  • Functional requirements specifications

  • Computer Systems Validation (SDLC)

  • Process validation and Investigations

  • Facilities, Utilities, Manufacturing, Packaging equipment qualification

  • Installation, operational, performance qualification protocols and Reports

PROJECT MANAGEMENT

  • Cost Controls

  • Schedule Controls

  • Small Capital Projects

  • Client Representative for Large Projects

ENGINEERING SUPPORT SERVICES

  • CMMS support

  • Instrumentation

  • Technical Staffing

  • Drafting Services | As-Built Drawing Generation