With the combination of installation, qualification, user-specific calibration, training, and documentation, you ensure the highest performance right from the start. Operational and functional testing procedures are performed and documented onsite by an authorized specialist. This includes proven qualification protocols and adequate environmental conditions according to customer requirements.
Při pořízení nového přístroje Mettler Toledo je potřeba zvolit několik služeb, abyste ze svého přístroje získali maximum. Všechny přístroje jsou před opuštěním výrobního závodu otestovány a zkontrolovány, aby bylo zajištěno, že splňují specifikaci. Jakmile dorazí na pracoviště zákazníka, nainstaluje je servisní technik v terénu. V závislosti na vašem odvětví a použití bude nezbytná určitá úroveň kvalifikace. Pokud stačí kontrola ve výrobním závodě, například v akademické sféře, je vhodný Starter Pack s funkčním kontrolním seznamem a zároveň tím začne běžet záruční doba. Pokud vaše odvětví nebo aplikace obvykle vyžaduje instalační a provozní kvalifikaci, například ve farmaceutickém nebo chemickém průmyslu, je nejvhodnější IPac. Tato služba zahrnuje ověření přístroje na místě a ověření jeho výkonu, aby bylo zajištěno, že po instalaci u vás stále splňuje specifikaci. Pro výrobní nebo průmyslové aplikace s přísnějšími požadavky na kvalitu, jako jsou FDA, GMP a Evropský lékopis, je nejvhodnější EQPac. Ten zahrnuje fyzický provozní deník pro vedení záznamů o veškeré servisní historii přístroje. Tato služba zahrnuje certifikaci materiálu pro všechny části přístroje nebo sondy přicházející do styku s médiem. Zahrnuje také validaci softwaru ICPROCESS. Zvolení úrovně kvalifikace, Starter Pack, IPAC nebo EQ Pack, pro váš přístroj zajišťuje, že splníte všechny své požadavky na kvalitu nebo předpisy.
Experience the METTLER TOLEDO Service Difference
Benefits of AutoChem Installation and Qualification
Immediate Deployment into Routine Operation
Compliance with Regulations and Standards
Evidence That Instrument Is Fit-for-Purpose
Efficient and Safe Operation
Audit-Proof Documentation
Installation Packages for Your Needs
Depending on your industry, regulation, and application, we have three levels of installation packages available to accommodate your specific requirements:
Professional installation
StarterPac
Professional product installation and solid user familiarization in low or unregulated environments, such as academia.
StarterPac Installation includes
1
Expert installation by factory-trained METTLER TOLEDO service engineer
2
Basic confirmation with functional checklist
3
Hardware and operation familiarization
4
Installation Qualification (IQ)
Recommended for the following industries
Academia
Popular
Standard qualification
IPac
Installation and operational qualification including documented compliance with internal standards and external regulations.
IPac Installation & Qualification includes
1
All items in StarterPac
2
Standard qualification documentation with functional checklist
3
Operational Qualification (OQ)
4
On-site instrument validation and calibration to manufacturing specification (product dependent)
Recommended for the following industries
Chemical
Pharmaceutical (may require EQPac)
Testing Labs
CDMO/CRO
Comprehensive qualification
EQPac
Comprehensive documentation with professionally executed IQ/OQ for applications with stricter quality requirements.
EQPac Installation & Qualification includes
1
All items in IPac
2
Software validation
3
Material certification (product dependent)
4
Maintenance logbook
Recommended for the following industries
Pharmaceutical (FDA and GMP regulated applications)
Equipment Qualification Activities
Installation Qualification proves that all material has been provided as intended:
Environment conditions according to equipment requirements
Completeness of supplied systems
Adequate installation
Operational Qualification proves that the installed system works as intended:
Correct operational functionality according to system specifications
Proven qualification protocols
Performance Qualification provides:
Support you in performing measurements under your responsibility
Regular examination of equipment performance
Continued accuracy and reliability of results
Maintenance Qualification provides:
Definition of preventive maintenance scope and intervals
Determination of parts replacement intervals
Service plan including all necessary measures and procedures to ensure full performance
The Equipment Qualification is a service solution specifically designed to address compliance needs in today’s demanding regulatory environment. It provides an onsite, fully documented, professional installation, following qualification processes to ensure quality requirements and reliable operation.
Equipment that Compliments Your Process
The proper setup and configuration of your equipment ensure that you leverage its full capabilities with:
Compatibility with your working environment, application, and process
Customized user interface for improved operator efficiency
Connections with peripheral devices and systems
Integration of data set-up with software applications
Automated Chemistry Equipment Service Brochure
The startup and maintenance requirements of lab instrumentation are often overlooked during the purchasing process. Selecting the appropriate service configuration for your new instrument provides the most productive and supportive work environment for your scientists – enabling them to focus on science to create a lasting business impact. This brochure will help develop your equipment maintenance and support strategy through METTLER TOLEDO services.
Do I need an AutoChem IPac Standard Qualification for installation?
If your data will be used to make business decisions that will impact your company financially yes, an AutoChem IPac would be the best option. In addition to what is included in the StarterPac, it also includes operational qualification (OQ). The technician performs on-site instrument validation and calibration.
Why are there different AutoChem installation offerings available? Isn’t there only one way to install the equipment?
There are different levels of qualification available for installation based on what is more appropriate for your company and application. If factory inspection is sufficient, like in academia, then the StarterPac with its functional checklist is appropriate and will trigger the start of your warranty period.
If your industry or application typically requires installation and operational qualification, like the pharmaceutical or chemical industries, then an IPac is most appropriate. This service includes on-site instrument validation and performance verification to ensure it still meets specification after installation at your site. For production or manufacturing applications with stricter quality requirements (FDA, GMP, and European Pharmacopeia), the EQPac is the most appropriate.
If the AutoChem instrument you’ve purchased will be used in a regulated environment (e.g. GMP), then the best option will be an EQPac. This service includes software validation, material certification, and a maintenance logbook, in addition to the Standard Qualification activities.
Is there an AutoChem installation checklist available prior to the technician coming onsite?
Yes, you will be sent a checklist after your order is complete. This will ensure all utilities needed are available during installation.
What is the warranty period for my AutoChem instrument?
We warrant our AutoChem products against defects in material and workmanship for 12 months from the date of installation or 18 months from the date of shipment to the buyer's destination, whichever is earlier, so long as all necessary maintenance and/or installation has been performed on the products and said products have been used in accordance with the published specifications. Should any products contain such defects, we will repair the product at no additional charge.
What repairs are not included during the AutoChem warranty period?
A repair will not be approved where METTLER TOLEDO equipment has been subjected to accident, alteration, misuse, abuse, or failure by the buyer to ensure proper storage, operation, maintenance, installation, and/or servicing by personnel METTLER TOLEDO does not authorize or due to environmental or operational conditions.
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