Project approach

Structured Efficiency

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To ensure that the required quality is achieved, the project will be managed through project phases, internal reviews, risk analysis and FMEAs. Separate customer requests, such as technical reviews and formal approvals, can be incorporated into the project scope.

  • Approvals by Customer (optional)
  • Design documents
  • System concept and System design
  • Components
  • FAT protocol


The project deliverables and activities are part of our internal processes; the GAMP® methodology is strongly weaved into our approach of project management. Applying procedures based on the Good Automated Manufacturing Practices method ensures that required quality levels are met for highly regulated industries. Inno4Life engineers are experts in supplying engineering-to-order equipment and machinery according to customer specifications.

HOW WE OPERATE

Concept development

A 'fit-for-purpose' methodology

At Inno4Life we strongly believe that quality driven reviews are necessary in each step of a manufacturing process or project. With this unique approach in close collaboration with strong partners, we are able to design and develop high-tech equipment to meet your unique specifications. Therefore, all the equipment will be fully tested to ensure that conformity with all demanded industry standards for quality, safety and reliability is guaranteed. The GAMP® methodology is strongly weaved into our approach of project management. Prototype development is part of the scope depending on the project specifications or assignment. Furthermore, Inno4Life is also able to develop modules / equipment as an Original Equipment Manufacturer (OEM).

Engineering

Experienced engineers apply a 'fit-for-purpose' dynamic project methodology. To ensure that your objectives are met, we work closely together with you every step of the way to deliver maximum result. Each engineering/ project stage is concluded with a phase-end review whereby specific topics are discussed and agreed upon. Depending on the complexity and the scale of the project, Inno4Life is able to offer a complete suite of solutions. Whether you need specific equipment, support in system integration or optimisation, contact the Inno4Life experts for advice.

Manufacturing

As part of our philosophy to help overcome the challenges our customers face, we manufacture equipment with high quality components. We do not believe in a one-size-fits-all concept. Our experts take it to the next level to find the most efficient and cost-effective solutions. Our solid partnerships with preferred suppliers help us to assemble the equipment according to specifications and schedule. Acceptance testing (FAT) and phase-end reviews are standard for manufacturing projects.

Installation & Commissioning

Successfully tested and accepted manufactured equipment is packed and carefully shipped to our customers for installation. The expert engineers install and test the equipment on site according to the unique commissioning process; "the I4L Design Verification" method. This phase is also concluded with an acceptance test (SAT) and lessons learned review with the customer towards a smooth transition to Qualification.

Documentation & Validation

Inno4Life's equipment, services and documentation satisfy the stringent requirements of highly regulated markets, particularly in compliance with regulatory and industry standards such as cGMP, GAMP  5, ASTM  E 2500-7, FDA (21CFR11, Material usage), CE/UL/OSHA.

Depending on the project scope Inno4Life provides all the required validated documentation.

Services

Apart from a standard installation, maintenance recommendation and spare parts for our supplied equipment, a full set of services is available to optimise operational functionality of your processes. Depending on your needs, Inno4Life can offer full-service maintenance contracts, technical support and subject matter experts to get the job done.

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Contact Inno4Life
  • Address: Druivenstraat 5,
    4816 KB Breda,
    The Netherlands
  • Phone: +31 (0)76 30 200 23
  • Email: Send us an e-mail
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