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

web: www.cesystems.eu | tel: +44 (0)208 144 5127 | email: info@cesystems.eu

Some of our customers:

Educational ToolCETech 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 DashboardGraphical 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 ReviewsMany 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 DocumentIt 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.

Standards DatabaseProvides 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 TestingSchedule routine sample testing for products and capture results to satisfy EU regulatory requirements and demonstrate conformity of series production

Test Report Expiry RemindersEnsuring 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 ReminderEnsuring 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 TrailRecords all product activities including creation, updates, events, complaints and updates to technical documentation.

TraceabilityCapture 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

Kevin Webb, Numatic International Ltd

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Factory InspectionsMonitor factory inspection frequency and upload latest inspection reports and assign compliance status to individual factories.

Monitor Dangerous ProductsView 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 AssessmentsCapture and maintain safety and risk assessments pre- and post marketing in line with EU legislative framework and latest EU Directives.

Event ViewView upcoming, open and closed events such as Test Report and Sample Test Expiry in a full calendar view.

ComplaintsSatisfy 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.

Screenshots

Screenshot 1 - Product Window 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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To arrange a demonstration please contact:info@cesystems.eu