Compliance
As part of our full turn-key services, the talented individuals on our compliance team help to ensure that IPS delivers capital projects that perform and conform. Our approach to managing Commissioning and Qualification (C&Q) activities benefits from the years of industry experience our team possesses, combining widely accepted project management practices and tools with practical, real-world application. By fully integrating the commissioning, start-up, and qualification activities into the design and construction schedule, a true critical path is determined.
Click here to view our Commissioning Flowchart Animation.
As stand-alone service providers, we have assisted clients by providing services that range from one-day consultations to multi-million dollar site projects. We typically deliver $15-20 Million in third party C&Q services per year.
What you get is a documented control process throughout your construction project that ensures that deliverables are verified against approved specification. For you, this means that there is a higher level of assurance that facilities, utilities, systems, and equipment will work to specs and that you will find fewer deviations during testing and qualification.
Our skill-set
IPS Commissioning develops/writes, maintains:
- User Requirements (UR)
- Critical Instrument Lists
- Tagging
- Calibration Programs
- Instrument History Files
- Preventive Maintenance Programs
- Controlled Drawing Files
- Document Control Programs
- SOPs
IPS Commissioning executes:
- Design Reviews
- Compliance reviews
- HACCP Reviews
- FMEA Reviews
- FATs
- Reception Verification
- Calibrations
- Certifications
- Critical PM Reviews and Training
- Risk-Based Impact Analysis
- Critical Component Analysis
- Closeout/Acceptance Reports
By possessing the detailed knowledge and extensive experience in system qualifications, IPS can coordinate commissioning and start-up activities to minimize redundant qualification testing. Creating commissioning documents that capture critical system information in a GMP compliant format allows for commissioning data to be used in the execution of qualification studies. Concurrent execution of IQ activities during the commissioning and start-up assures that proper installation documentation and vendor certifications are in place prior to the formal qualification reviews and closeouts. On-site commissioning and start-up management by experienced C&Q personnel provides for early detection of problems that can delay qualifications and the overall project schedule.
IPS Compliance/Validation Services include:
- Qualification and Validation
- Impact Assessments and Master Planning
- Construction & Design Interface/Review
- Equipment Selection
- Project Management
- Quality System Implementation
- Calibration System Consulting
- Audits
- Quality Systems
- FDA-Style
- cGMP
- Remediation of FDA Form 483s/Warnings
- Validation and cGMP Training
- Process and Cleaning Validation
- Automation and Computer Systems Validation
- Document Development/Management
- Specification/SOP Preparation
- Site/Project Document Control
- Custom Protocols
- Factory/Site Acceptance Test
- 21 CFR Parts 111 and 112, Dietary Supplement Final Rule
- Whole Building Commissioning
- LEED® Commissioning
- Maintenance and Reliability Programs
- Energy Studies
- RetroCommissioning
To see our extensive list of Subject Matter Experts click here