Qualification Packages ensure instrument compliance.January 10, 2008 -
Packed along with MonARC instruments, EQ Pacs (Equipment Qualification Packages) assure customers that applicable industry-specific quality and safety standards are met by showing compliance in case of audit by internal/external regulatory bodies. Solutions cover everything from beginning, with compliant release of equipment for routine operation, and following with support of qualification needs throughout product life cycle. Each EQ Pac offers documentation and installation service.
(Archive News Story - Products mentioned in this Archive News Story may or may not be available from the manufacturer.)
Original Press release
Mettler Toledo, Inc.
1900 Polaris Pky.
Columbus, OH, 43240
USA
MonArc Equipment Qualification Package Now Available
METTLER TOLEDO is pleased to introduce a series of EQ Pacs to the market. With the introduction of this Equipment Qualification Package for our MonARC instrument line, we are providing a service product for customers who must strictly adhere to regulatory and quality compliance guidelines.
Driven by the demands of customers and the need to remain internationally competitive, there is increasing awareness among companies producing goods for end users or business customers to ensure the quality and safety of the products. When purchasing and then applying METTLER TOLEDO equipment, the customer needs assurance that applicable industry-specific quality and safety standards are met to show compliance in the event of an audit by internal or external regulatory bodies. Equipment Qualification Packages (EQ Pacs) are designed to support our customers in their efforts to do so - beginning with compliant release of the equipment for routine operation and following with support of our customers' qualification needs throughout the product life cycle.
An EQ Pac offers customers a documentation package and installation service specific to the METTLER TOLEDO equipment. When you customers order the EQ Pac, you receive the documentation package with their equipment kit at time of delivery and a follow-up visit from a METTLER TOLEDO Field Service Engineer certified to perform the service. The certified Field Service Engineer completes the EQ Pac documentation during installation with verification by the end user as assurance of compliance with quality and safety standards prior to routine operation.
EQ Pacs offer you the the following benefits:
o Cost and time savings due to professional and quick installation and verification ofthe purchased instrument performance as well as its immediate integration into the customer's processes
o Confirmation that the system arrives as ordered and has suffered no significant degradation during the shipping process
o Productivity increase due to prompt instrument familiarization of end users which enable them to work safely and efficiently with the new equipment right away
o Compliance support due to competent execution by a certified METTLER TOLEDO professional. The well-proven qualification procedure serves as docentation of adherence to industry and/or quality requirements
o Ongoing assurance that the system is maintained correctly and will continue to give results within original equipment specifications.
The EQ Pac contains:
o Unpacking and inspection to determine system arrived as ordered
o Assurance that site preparation has been performed according to specification
o Installation of the instrument and completion documentation (IQ)
o Performance of system qualification testing and completion of documentation certifying system ready for operation (OQ)
o System acceptance and release for routine operation
o Equipment Qualification Report
o Customer agreement for ongoing performance qualification activities and forms
o Certificate of IQ and OQ completion
o Certificate(s) of training and traning log of end user(s)
o Log of qualified service engineers
o Declaration of Conformity
o Maintenance Qualification
o Appendices
o Reference Materials
- MonARC Remote Configuration Tool Manual
- MonARC Process Instrument Application User Manual
- MonARC Technical Specifications
- MonARC Operational Tests
- Training Certificates of Qualified Engineers
- METTLER TOLEDO AutoChem Service Brochure
When ordered, the tangible product (MonARC EQ Pac, order number 14142050, N-0026-EQPAC-MON) is packed and shipped along with the instrument. The MonARC EQ Pac consists of:
o MonARC EQ Pac Binder (one inch, three-ring dividers) with cover and spine inserts
o Equipment Qualification Documentation
o Equipment Specific Operational Tests and Supporting Documentation
Lasentec and ReactIR services
|
|
|
|
|
|
|
| 
