Life Sciences System Validation

Innovative Controls can support all your pharmaceutical and biotechnology automation needs.  We offer both validation and automation services to ensure a successful and cost effective project while providing the highest quality service with strictest confidentiality.

Engineering Services - Life Sciences

 Innovative Controls is a registered ISO 9001 firm.  This strict certification reflects our commitment to providing quality and excellence to the automation industry.  Our engineering department has an established reputation for providing innovative solutions for complex applications while maintaining compliance to regulations throughout our history.

pharma

The flexibility of our services allows us to assist in any or all aspects of the validation process.  Our proven experience ensures that the design, implementation, operation and qualification efforts progress smoothly.  Our project management team maintains oversight on all aspects from start to finish ensuring that project milestones are met with the budget and schedule.  We have the automation experts on staff that will maintain ownership and provide as much or as little assistance as necessary to meet your goals throughout the project life cycle.

Qualifications

  • Proven FDA validation experience
  • ISO 9001 registered firm
  • Siemens Pharma Approved solution partner
  • Employees are trained in cGMP
  • Solutions are developed using IEEE based life cycle software engineering practices
  • Configuration comply with ISA 88 Batch standards
  • All solutions support 21 CFR Part 11 electronic records and signatures

Validation Solutions

  • Validation master plan development
  • Functional requirements
  • Functional specifications
  • Installation qualifications
  • Operational qualifications
  • Performance qualifications
  • Gap assessment
  • Risk assessment
  • Final report development
  • Controls and automation validation