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KEISDATA s.r.l.

All rights reserved

2013

Information Platform of Knowledge

and Risk management

The safe guide for certification and

compliance

(2)

Support companies in the process of certification and compliance management system to the evolving legal frameworks, standards and regulations, increasing the

effectiveness and efficiency of their business

KEISDATA, since 1995, has carried out many projects to build systems certified according to regulations and European standards in the areas of Quality, Health and Safety, Environment, Energy, CSR, Model 231.

KEISDATA partners have extensive experience in international contexts, include:

ACER, Selerant, Bayer, P&G, Nooter/Ericksen, Gruppo Angelini, Lundbeck, Total, Hay Group, Watson Wyatt, Joint Research Centre European Communities, University of Missouri, Monsanto Company.

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KEISDATA s.r.l.

All rights reserved

PI-KR is an Integrated Solution for Management

Systems and Corporate Governance

PI-KR is a platform that allows the Company to manage Systems in an integrated way and through a gradual approach according to the route of sustainability of the Company. The modular structure allows the Company to apply the platform to one or more management systems.

In PI-KR both the Risk Management process according to ISO 31000/2009 and the process of Knowledge Management system that allows you to integrate business knowledge and people knowledge, are applied.

PI-KR is characterized by the integration of the specific procedure to a specific issue and together with the Knowledge and Risk Management common processes for the effectiveness and efficiency of the Management Systems and Regulatory Compliance.

THE INNOVATIVE CONCEPT

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PI-KR is the integrated solution to manage

Process of risk assessment,

Business and human resources processes System procedures,

Operating instructions, Technical documentation

Authorization legislation or mandatory, Data Management Systems

Business knowledge and people knowledge

Business grows together with Risk

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KEISDATA s.r.l.

All rights reserved

Harmonization of the certification rules promoting the application of the

statutory and regulatory requirements

Application of a single mode of work for the analysis and assessment of

risk

Creation of a Human Resources Area, common to all management

Systems, apt to perform the analysis, the assessment and the management

of personnel

Creation of an Observatory Area, common to all management systems, apt

to perform the reporting, the analysis, the evaluation and the

management of nonconformities

Single Model of Risk Assessment

THE SINGLE SOLUTION

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KEISDATA s.r.l.

All rights reserved

PI-KR: A COMPLIANCE MANAGEMENT SYSTEM

The PI-KR

manages Compliance and Legal Requirements

under the Standards of Certification

Risk Assessment and Drafting of DVR (D.Lgs. 81/08 e s.m.i.)

Construction Sites Risk Assessment and Drafting of POS (D.Lgs. 81/08 e s.m.i.) Interferential Risk Evaluation and drafting of DUVRI (D.Lgs. 81/08 e s.m.i.) Computerized Accident Register (D.M. 12/09/58 )

Emergency Plan (D.M. 10/03/98)

Personnel Training Certification (D.Lgs. 81/08 e s.m.i.)

Environmental monitoring prescribed by authorizations (water wastes, emissions, noise, etc..)

Integrated Environmental Authorization (D.Lgs. 152/06 e s.m.i.)

Major-accident hazards involving dangerous substances (D.Lgs. 334/99 e s.m.i.) Best Environmental Practices (BEP) (D.G.R. n. 7/19797 del 10/12/2004)

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Converts the System procedures in graphical representations

(flow-chart) that become guidelines for the maintenance of certifications

Produces homogeneous and validated data in accordance with mandatory

law

Produces a dashboard of indicators, makes comparisons with limit

values ​​or reference points and reports anomalies, trends and correlations

with data from different Systems

Adopts methodologies of risk assessment in accordance with

the ISO 31000/2009 guidelines

It provides tools to acquire business and individual knowledge

Implements consistency rules between procedures, delegation of roles and

responsibilities

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KEISDATA s.r.l.

All rights reserved

It allows the management of privileges associated with different delegations

of roles and responsibilities

It incorporates the new requirements arising from laws’ amendments

and alerts the norms’ addresses

It manages the whole lifecycle of a document, tracks versions by

historicizing them and provides access to the latest version

It plans and manages activities and deadlines

It allows the creation of the Master Document (autocomposition of multiple

subdocuments) to describe:

o

Procedures, Protocols, Risk Assessment Documents

o

Environmental Analysis Report, Sustainability Report, Energy

Balance, etc.

…….CONTINUED

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It allows the drafting of reports

It provides specific monitoring plans apt to integrate data analysed

by laboratories/suppliers

It allows the targeted management of communication and information

processes directed to both internal and external stakeholders

It manages the entire process of education and training: from the

identification and analysis of individual and collective needs to the

verification of the effectiveness of the conducted activity by tracking

progresses in the resource’s booklet

It manages the whole process of health surveillance: the Annual Health

Plan, the Program of visits and the Register of biostatistical data.

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KEISDATA s.r.l.

All rights reserved

THE PROCESS OF KNOWLEDGE AND RISK MANAGEMENT

APPLIED TO PROCEDURES

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THE ADDED VALUE

Adavantages for Companies that apply the certified PI-KR

• The identification, formalization and consistency of processes, roles and responsibilities in order to improve clarity and organizational effectiveness;

• the ability to manage the company’s know-how and to support users in achieving their objectives with accuracy and completeness;

• the production of data, documents (manuals, procedures / protocols, forms, reports, monitoring plans, etc..) and information that is validated, homogeneous, and in line with regulations;

• the identification of critical variables to be monitored in order to determine the most appropriate measures to be taken;

• the ability to ensure the continuity of operations and to maintain the performance in the established conditions and time frames;

• the adoption of homogenous tools for education and training within the company;

• the availability of performance indicators oriented at ensuring the development, the integration and the continuous improvement of Management Systems;

• the planning and management of activities and deadlines;

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KEISDATA s.r.l.

All rights reserved

STATEMENT OF COMPLIANCE OF THE SOFTWARE TO

STANDARDS OF CERTIFICATION

In 2011 it was certified that PI-KR complies with the requirements defined by Certiquality and, after several audits, the Certificate of Compliance of the Software PI-KR for the implementation and maintenance of the Standard of CorporateManagement Systems was obtained:

• UNI ISO 9001:2008 Quality

• BS OHSAS 18001:2007 Health and Safety

• UNI ISO 14001:2004 Environment

• ISO 50001:2011 Energy

• ISO/IEC 27001:2005 Information Safety

• SA8000:2008 Social Responsibility

• UNI ISO 10015:2001 Training

The software was certified as compliant with the 2008 Confindustria (Iitalian Industry Confederation) Guidelines for the construction of models of management and control and for the corporate liability regulation (Legislative Decree 231/2001).

It meets the requirements of the Net Audit.

It is based on the quality requirements contained in ISO/IEC 25010 and on the principles and methods of Risk Management (ISO31000:2009) and Knowledge Management.

The first certification "Certisoftware" obtained by PI-KR issued by Certiquality (Italian main certification body)

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THE CERTIFICATE OF COMPLIANCE OF THE SOFTWARE TO

THE STANDARDS FOR SYSTEMS ASSEVERATION

In 2010 the Certificate of Compliance of the Software PI-KR to the AJA Registrars International Certification Body Standards was acquired :

X-ULT Advanced Management System

X-SAFE Management System on Occupational Safety and Health inspired to the UNI-INAIL Guidelines

X-AEQUO Management System for Equal Opportunity in a gender perspective X-231 Organizational, Management and Control System inspired to the

Legislative Decree no. 231/2001 Folowing to the AJA Registrars audit.

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KEISDATA s.r.l.

All rights reserved

IT TECHNOLOGY AND ARCHITECTURE

.NET framework - Data-Base SQL Server

Authentication and Authorization System

•Safety

• Privileges

Interfacing Architecture

• With external data sources to the company's information system without reducing the level of security

• To connect to third parties’ applications

• To perform import activities

Navigation System and Guide

• Different levels menu

• Hypermedia Map

• Bidirectional document integration (reading and writing)

• Third parties’ UI integration (web-based) Document system

• Tracking and versioning

• Document Management

• Documental Contexts

• Master Document

• Work-Flow

System Acquisition, Analysis and Data Processing

• Data acquisition form

• “Cascade” Form

• Data dynamic update: exchange of data between forms

• Creating Brochures: scoreboards and summarizing

• Customization activities that do not involve changes in the application as they work on the data model

Management System Activities and Deadlines

Planning

• Summarizing

Communication Management System

•Notifications and Alerts

• Tracking notifications

Decision Making System Dashboards

•Maps of decision consistency

•Interactive maps

•Graphic structure of data processing

•Set of indicators according to different levels of decision

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INFORMATIC FEATURES (ISO 25010)

Effectiveness – Efficiency

The software uses well available resources

Flexibility - Usability

The software manages well the interaction with users

Maintenability

The software follows the evolution of the organization

• Tracking

• Authorization

• Duties Segregation

• Internal training and communication

Allows the creation

of new models/systems in a understandable and enjoyable manner

Ensures the update of Models /existing Systems, by integrating the requests from the organization's development, from the legal framework and from the requests of continuous improvement

Integration and Security Analysis (Features)

The software’s features meet the regulatory requirements of software validation

Performance and scalability (portability)

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KEISDATA s.r.l.

All rights reserved

c/o Tecnocity Alto Milanese Via Pisacane, 46 20025 Legnano (MI) P.IVA 12218800154 C.F. 01142620333

Tel. 0331 485106/543962 Fax. 0331 077535

For information:

info@keisdata.com

cerlesi@keisdata.com

www.keisdata.it

17

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