DOT Compliance Suite Overview

In a nut shell…

DOT Compliance Suite is a cloud Quality and

Compliance management solution for highly

regulated industries compliant with FDA 21 CFR

Part 11 and ISO13485.

The application contains industry’s best

practices processes catalog as a starting

point for easier and cost effective deployment.

Developed on Force.com platform – the

world’s leading cloud solution for maximum

performance and security.

Best

Pra

cti

ce

Rational for Change

• Compliance with FDA/EMA and ISO 13485 requirements

• Reduce regulatory compliance risks

Compliance Adherence

• Detect quality issues earlier – act faster globally

• Risk based approach

• Better control of changes

Reduce Risk

• 360° process view – cross function, department, subsidiary or site

• Real time updates

• KPI and Dashboards

Visibility & Traceability

• Reduce manual effort

• Faster global change management & NPI

• Use global resource pool

Efficiency

• Standard processes

• Standard performance measurement

• Standard tools and methods

Quality Culture

• Share information across sites & functions

• Preserve knowledge

• Collaborate with Supply & Distribution

Collaboration

Pro

cess

es C

atal

og

Medical Device[1]

Document Management

Document Revision Control

Read & Understand

Training Periodic Review

Training Management

Training Plan Employee Job

Functions Certification

Training Assignment

Adherence reports

Change Control

ECO Action Item Implmentation

Check

Non-conformity/

CAPA NCR Investigation CAPA

Effectiveness Verification

Safety Tracking

Complaint Adverse Event Vigilance Reporting

Risk Management

Risk Mng. Plan Risk Evaluation Risk Control

Audit Management

Audit Plan Internal Audit External Audit Observation

Pro

cess

es C

atal

og

Regulatory Affairs

FDA/CE Registration

Variations Renewals Regulatory

Correspondence

Product Product BOM ASL

Device/Batch Device Master Record (DMR)

Device History Record (DHR)

Equipment Management

Equipment/ Process

Equipment validation

Process Validation

Supplier Quality

Supplier Evaluation Supplier Audit Score Cards Supplier Portal

Medical Device[2]

Back

Pro

cess

es C

atal

og

ERP CRM

PLM

LMS

SQM Document

Management

Maintenance

LIMS

MES ELN

CTMS

Regulatory

Affairs

ERM(Risk)

Processes Landscape

Holistic cost effective solution for needs that traditionally were met by several separate costly systems Back

Custom Processes

DOT Compliance Suite provide full

customization and integration capabilities allowing

your organization to realize specific non-standard

processes.

Custom development leverage the platform

allowing a cost-effective and agile delivery of 21

CFR Part 11 compliant solutions.

Custom design, configuration, integration and

validation services are available.

Leverage the advantages of DOT Compliance

suite for custom solutions:

Solution Benefits

Best Practices Flexible Reliable Cost Effective

Pre-configured

processes to meet

industry needs and

compliance

requirements

Agile and cost

effective

customization.

Full API and

integration

support

High Availability

Disaster Recovery

ISO 27001 Security

certification

Scalable

Trusted

No capital investment

Competitive pricing

Minimal IT costs

User

Experience

Accessible Eco-System

Support

Analytics

Easy to use

Customizable

Multilingual

Consistent user

experience

globally

Mobile/Tablet access.

IOS and Android

support.

Consistent reliable

performance

globally

Secured portal

access to suppliers

and external labs

allowing them to view

and update relevant

data

Built-in flexible

reporting.

KPI’s and

Scorecards

Easy Data export

Reliable Solution

Force.com Platform is widely use by large organization in the

healthcare, pharmaceutical and life science industries

Trusted [1]

Force.com is trusted by major healthcare and pharmaceuticals

Source: Salesforce.com

Trusted [2]

Force.com is trusted by regulated industries

Source: Salesforce.com

Some of Dot Compliance Customers

User Interface

Standard

SalesForce User

Experience

Easy Navigation

and Data

Management

Visual Record

Lifecycle

Electronic

Signature

Dashboards,

Report and KPI’s

Mobile Access

Android & IOS

Mobile Phones & Tablets

Native User Experience

Eco System support

Community cloud provides “best of breed” portal solutions used by large organizations globally.

Simply get to the point

Deployment Methodology

Deployment Methodology In

itia

te

Scope and Key Processes definition

Assign Project Team, map stakeholders and sponsors

Develop project plan and schedule

Core team Product Orientation F

un

ctio

nal

Gather Business Requirements

Review “Best Practice” configuration and assess gaps

Document functional requirements, Workflows and data model configuration

Map integrations and custom code requirements

Map data migration activities

Te

ch

nic

al

Design & Configure Prototype for CRP

Conference Room Pilot (CRP) with key users

Design & Configure custom elements and integrations

Design & Configure Reports and Dashboards

Design & Configure Profiles and Security

Va

lid

ate

User Testing

Installation and Operational Qualification

Preform and Validate data migration

SOP & Work instruction Update

Validation Summary Report

De

plo

y

User Training

“Go-Live” system Rollout

Hyper Care support

Op

tim

ize

Collect requests for enhancements and develop future roadmap

Transition to support

Periodic System Health Checks

DOT Compliance Suite implementation methodology is based on best practices

for delivery of solutions to highly regulated organizations.

DOT Compliance Suite is designed for Agile Phase Implementation approach:

Start with few core processes and as your organization grows and mature deploy

additional required processes.

For more information

info@DotComplianceSuite.com

www.DotComplianceSuite.com

+972-54-7878808