Commissioning & Validation (CV)
We are happy to provide our extensive experience and expertise when selecting appropriate medical decontamination equipment for specific needs and requirements of individual sterile services departments.
The commissioning and qualification specialty of AGNOTEX focuses on facilities, processes, and manufacturing in the Medical Device industries.
We provide a full range of services in startup, commissioning, qualification, validation, maintenance programs, training, operational procedures, and other regulatory compliance services for the Medical Device Industry.
Specializing in:
Verification of Construction activities and installations per design specification.
Startup of production facilities:
1) Facilities | 2) Clean and Plant Utilities | 3) HVAC |
4) Process Equipment | 5) Control Systems (BMS, PLC based, DCS) |
Commissioning, qualification and validation of processes and facilities to ensure compliance and approval to meet design specification.
Coordination and acting as liaison for project between the owner, design, construction, commissioning, startup, validation, and the various owner groups (e.g. manufacturing engineering, maintenance, and quality)
AGNOTEX works on projects ranging from single pieces of equipment or system to complete green-field manufacturing facilities. We are familiar with government regulatory requirements (e.g. FDA, EMEA, WHO, etc.), ISPE commissioning and qualification guidelines, ASTM E2500 Verification, EPCV, the “V-model”, and traditional validation approaches. Major services provided by CV division include:
Commissioning / Qualification and Validation Planning.
Early Project Planning.
Coordination and Management of Vendors.
Ensuring Overall Quality Compliance to Meet Client Specifications.
Startup Coordination and Planning.
Design Audit.
FEMA Analysis.
Development and Execution of Commissioning Documentation.
Development and Execution of Validation Documentation.
Preparation of Final Reports.
FAT Documentation Coordination, Execution, and Oversight.
Punch Listing to Guarantee Construction Completion.
Coordination Care-Custody-Control Turnover.
Decommissioning.
1) Initial Site Investigation | 2) Project Cost Analysis |
3) Historical File Review | 4) Preliminary Site Survey |
5) Decommissioning Plan Development | 6) Technical Supervision |
7) Regulatory Assistance | 8) Waste Management |
Areas of CV dept. Expertise:
Startup, Commissioning, Qualification, and Validation Project Management
21CFR Compliance
ASTM E-2500 Risk Based Approach
ISPE Commissioning & Qualification Guidelines
Leveraging Vendor, FAT, and Construction Activities
Validation Program Management
Process Validation
Cleaning Validation
Facility Qualification
Equipment Qualification (IQ, OQ, PQ)
Critical Utility Qualification (IQ, OQ, PQ)
Automated Systems Validation
Process Transfers/Validation
Analytical Method Validation and Stability Program
Decommissioning
Decommissioning Documentation
Protocol Development, Execution and Final Report
Equipment Exit PM Coordination and Database Update
Instrument Exit Calibration Coordination and Database Update
Spare Parts Inventory Reconciliation
Decontamination Studies
Validation File Reconciliation
Decommissioning Project Management
Project Plan Development and Execution
Project Schedule Development
Cost Control
Project Team Management
909-17th Ave S.W., Suite 400, 4th Floor, Calgary, AB, T2T 0A4, CANADA. |