What is CETech? - CE Systems, your technical file solution

Transcription

What is CETech? - CE Systems, your technical file solution
TECHNICAL FILE SOFTWARE FOR EU DIRECTIVES
Toy Safety, Low Voltage, EMC, Machinery,
R&TTE, RoHS/WEEE, Ecodesign
What is CETech?
CCETech is intended for manufacturers, importers and distributors of toys, machinery and
electrical products. It provides a dedicated technical file storage, retrieval and alerting system
that can be controlled and verified. Benefits include:
Centralised location for product safety technical documentation
Available in the ‘cloud’ and enabled on the latest tablet devices
Reduced effort and risk in generating and maintaining a Technical File
Ability for suppliers to upload technical documentation into CETech
Improved efficiency of teams responsible for regulatory compliance
Control over conformity of series production
Reduced risk of design or component changes adversely affecting product safety
One-click Product Control Document showing compliance status
Swift compilation and provision of documentation for enforcement authorities
With forthcoming EU legislation introducing technical documentation and traceability
obligations, CETech provides a proven means of achieving a scalable and fully audited
compliance system for EU Directives.
For further details please visit our website:
www.cesystems.eu
Some of our customers:
web: www.cesystems.eu | tel: +44 (0)208 144 5127 | email: info@cesystems.eu
Standards Database
Educational Tool
CETech is a logical and analytical tool.
Through its application the organisation will
benefit from a thorough understanding of
the procedures involved in achieving and
maintaining compliance with CE-marking
legislation. Intuitive design provides a means
of uploading, reviewing and approving
technical documentation.
Graphical Dashboard
Graphical illustration of technical file content
and gaps. The dashboard provides the
organisation with a customisable overview
of all products entered into the database
allowing the user to drill down to individual
products.
Critical Component Reviews
Many products fail due to unscheduled critical
component changes. CETech provides the
means of demonstrating due diligence by
scheduling regular correspondence with the
Manufacturer or Supplier providing details of
changes to critical components.
Product Control Document
It is a legal obligation to provide evidence
of technical documentation to Market
Surveillance Authorities in a timely fashion.
The PCD provides in one-click a summary of
supporting technical documentation, which
may be provided to the Authorities during
routine enquiries or at the first stage of an
investigative process.
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Provides a repository for harmonised standards
and their amendments which can be applied
to products. Products are identified when
a standard has been superseded by a later
amendment, prompting the update of technical
documentation and retesting where necessary.
Schedule Sample Testing
Schedule routine sample testing for products
and capture results to satisfy EU regulatory
requirements and demonstrate conformity of
series production
Test Report Expiry Reminders
Ensuring product maintains compliance with the
latest editions of harmonised standards. Events
are scheduled automatically from the issue date of
test reports. Track results of mitigating actions in
the Product Audit Trail.
Plug Certificate Expiry Reminder
Ensuring fitted plug approval is maintained.
Events are scheduled automatically from approval
certificate issue date. Track results of mitigating
actions in the Product Audit Trail.
Full Product Audit Trail
Records all product activities including creation,
updates, events, complaints and updates to
technical documentation.
Traceability
Capture exposure details, date placed on market
and batch and serial number information to satisfy
legislative traceability requirements.
CETech is a very comprehensive software package that helps us ensure full compliance with the EU Machinery, Low
Voltage, EMC, RoHS and Ecodesign Directives. It gives us a robust structure to compile and manage our approvals
documentation for our broad product range and gives us confidence that we are complying with existing and future
legislation
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Kevin Webb, Numatic International Ltd
Factory Inspections
Monitor factory inspection frequency and upload
latest inspection reports and assign compliance
status to individual factories.
Monitor Dangerous Products
View weekly RAPEX reports and other important
websites from within the system to identify
products posing a serious risk of injury or
information that may necessitate updating the
technical file components.
Store Safety Assessments
Capture and maintain safety and risk assessments
pre- and post marketing in line with EU legislative
framework and latest EU Directives.
Event View
View upcoming, open and closed events such
as Test Report and Sample Test Expiry in a full
calendar view.
Complaints
Satisfy legal obligations under General Product
Safety Legislation by recording complaint details
and assigning an appropriate status. Capture
mitigating actions and track within the Product
Audit Trail.
To arrange a demonstration
please contact:
info@cesystems.eu
Screenshots
Screenshot 1 - Product Window
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Screenshot 2 - Event View
The revised Toy Safety Directive 2009/48/EC adds a number of mandatory obligations for toy products. The recording
and holding of the technical documentation for a product is increasingly complicated. CETech offers a single database
that can store all of the TSD documents in one location. In addition it can help companies manage their obligations on
conformity of series production by managing changes in harmonized standards and by holding factory audit details.
Summary sheets can be produced that highlight key compliance details for customer and enforcement enquiries. In my
opinion this system is an extremely useful tool to help manage ever increasingly complicated legislative requirements
Jerry Burnie, Independent Quality Solutions
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