Design & Other Services
From preliminary design to a full turnkey solution, Precise Engineering provides professional and personal attention, to fully address most challenging requirements.
All our engineering services are in accordance with the highest regulatory requirements:
- Relevant regulatory authorities, such as local ministry of health, FDA and EMEA
- Latest version of cGMP (c) and GAMP (Good Automatic Manufacturing Practices)
- ISPE latest recommendations
Precise Engineering is ISO-9001:2015 certified (since 2005)
Precise Engineering provides best of breed design services, with exceptional design deliverables.
Functional Design and Basis Of Design (BOD)
From concept and feasibility checks to a full set of requirements, Precise Engineering compiles all project aspects and considerations into a project requirements document– the Basis Of Design (BOD), which includes:
- Conceptual Design
- Site & Utilities Survey
- Functional Design
- Operational design
- Regulatory compliancy considerations
- Economical aspects
- Utility Matrix
Detailed Design
Precise Engineering detailed design optimally addresses all project requirements, resulting in a reliable, functional and economical product.
- Multi-disciplinary detailed design
- Comprehensive responsibility - from facility aspects to the smallest details and drawings
- 3D, Super-positioning and Imaging
Supervision & Project Management
Precise Engineering’s experience in managing and supervising large and complex projects enables us to minimize risks and costs and to maximize quality. With a deep know-how in Design, Regulation and Qualification, we ensure best project results with:
- Professional field inspection
- Budget and schedule control
- Tenders and bids writing & management for materials, components and equipment
Turnkey Project
From concept to handover, Precise Engineering provides a complete one stop shop turnkey solution offering overall responsibility for the entire project stages and aspects as well as its success:
- State of the art design
- Components and materials purchase and supply
- Project implementation according to design, while minimizing risks, schedule lags and interfaces between functions
- Professional installation, commissioning, and validation, providing quality product, compliant with requirements
- On-going customer progress updates, and validation reports
Validation & Qualification
Precise Engineering’s validation and qualification processes for all project stages and critical systems ensure smooth commissioning in compliance with the regulatory standards and the customer requirements:
- DQ – Design Qualification
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance Qualification