CIMCON Software is an ideal partner to accelerate your Digital Transformation journey. With offices in the US, UK and Asia-Pacific, 500 customers in 30 countries, 24/7 support, and partnerships with multiple Cloud and technology vendors as well as Value-Added Resellers across the globe.

2. CIMCON Transform to
Digitize Your Forms
 Transform your existing Paper Based Forms to a
Digital Web-based System
 Automatic migration of existing compatible
Forms
 Sign-off using electronic signatures
 Review and approval workflow
 Fully 21 CFR Part 11 compliant
 Analyze form data for reporting, collaboration
and insights for greater efficiencies

3. FORM
MANAGEMENT.
Digitize your Paper Forms
with
E-Signatures
PRODUCTS
PAPERLESS DATA
INTEGRITY
MANAGEMENT.
Purpose-built solution designed
to help you monitor, track and
manage your company's data
integrity compliance status.
LAB/INSTRUMENT FILE
MANAGEMENT.
Secure your lab/instrument files
with continuous monitoring,
workflow management and Part
11 compliances.
QUALITY MANAGEMENT
SYSTEM (QMS)
Store all your enterprise content
in one centralized repository,
with a single version of the
truth.
TRAINING
MANAGEMENT
Paperless management
of training records for
improved compliance
and productivity.

4. "Charles River Labs (CRL) has implemented and is using the eInfotree Excel Desktop for over 2 years now. eInfotree has been deployed enterprise-wide in North
America and Europe, and the scope of the implementation includes 17 sites (and counting) within Charles River with nearly 7,000 eInfotree Excel desktop client
installations at these sites, using a centralized server model.
eInfotree has been a valuable tool in our Digital Transformation journey helping us to make our spreadsheets 21 CFR Part 11 compliant as well as adhering to
our Data Integrity plan and governance. It has saved us hours of work that was earlier spent in verifying calculations, printing the spreadsheets and applying
hand signatures, and then filing and storing all the printouts. It has also helped us in our audits since our spreadsheet controls are now automated with lower
potential for human error. Resolving CAPA issues is now a breeze as the eInfotree audit trail provides an immediate history and timeline of any changes made.
Furthermore, Charles River have now initiated the conversion of several paper forms into Excel forms, accelerating our digital efforts towards a paperless
environment, applying not only further compliance but electronic approval of forms as well, significant paper reduction and increase efficiencies in form
processing, archiving and retention. Overall, we estimate that eInfotree has reduced our costs by an estimated 20% in terms of the time and effort saved, while
automating our data integrity and compliance processes.
The scalability and configurability of the product has been impressive, while the professionalism and responsiveness of CIMCON’s customer service team has
been exemplary. It is clear to us that at CIMCON, the entire company is highly motivated and dedicated to ensure customer success, and it is not just a slogan.
We look forward to working with them in the near future, on our Digital Transformation journey and Data Integrity initiatives."
- Alain Fraser | Director, Computerized Systems Validation at Charles River Laboratories
TESTIMONIALS

5. CIMCON UNIVERSITY FOR
TRAINING.
We offer standard training courses for
administrators and end-users. Custom training
can be designed and delivered as well geared
to your specific needs.
MANAGED SERVICES
We can provide managed services where we can
manage the product implementation for you, and
essentially serve as your system administrators.
This includes managing system configuration, user
training, help desk and regular server monitoring.
RPA/GRC/ENTERPRISE INTEGRATION
Advanced API services and tools help integrate our products
with other enterprise business applications and tools such as
GRC, Robotic Process Automation (RPA), Cloud providers or
others. We can provide services to integrate with any of your
existing applications to provide data on an aggregate basis,
optimize your processes and derive maximum value from your
investment in CIMCON and other tools.
CLOUD MIGRATION
LINK FIXING
When files are moved from standard file servers to cloud
repositories such as AWS, Azure, Box, SharePoint, Dropbox,
and OneDrive, the file links can break. CIMCON’s Link Fixer
tool can identify these links, and then fix them before or
after migration.
ACCESS DATABASE TO MANAGED
APPLICATION
We can eliminate legacy Access databases and
migrate them to a modern, managed system with a
SQL Server backend. CIMCON has extensive
experience and a pre-built library of tools to help
achieve this migration quickly and efficiently.
CUSTOMIZATION
We offer customization services to meet the
highly -specialized needs of our individual
customers. Customization is performed after a
detailed technical analysis by our technical
services group.
SERVICES

6. VALIDATION AND PART 11 SERVICES
As a part of their Digital Transformation initiatives,
increasing regulatory scrutiny and requirements to
comply with national and international regulations,
companies are rapidly replacing manual and paper-based
processes with electronic systems. Due to their
experience and background, CIMCON Software
consultants are well equipped to qualify your digital
systems of varying levels of complexity and help you stay
compliant. CIMCON optimizes the time and cost of
validation by applying a risk-based approach to each
system. CIMCON can also provide a wide range of
automated tools as part of the consulting engagement to
provide you with sustainable compliance.

7. VALIDATION AND PART 11 SERVICES
CIMCON is a recognized leader in providing compliance solutions to the FDA-regulated industry with a global client
base that spans North America, Europe and Asia. CIMCON consultants combine regulatory knowledge with
technical expertise to provide solutions to issues instead of simply highlighting them. CIMCON’s validation
methodologies have been developed after years of real-world field experience to ensure successful project
outcomes, and include widely followed practices such as GAMP 5. We strive to deliver value as an added
ingredient in all our deliverables with a view to improving operations and productivity and simplifying processes
with compliance as a by-product.
CIMCON offers a wide range of services that include validation planning, risk assessments, Part 11 assessments
and remediation plans, preparation of validation documents and SOPs, protocol execution, deviation resolution
and training. CIMCON regularly contributes to industry conferences, journals, tradeshows and events and is in tune
with current FDA thinking and future direction.

8. REPRESENTATIVE PROJECTS
21 CFR Part 11 Services
• Gap Assessment
• Strategy and Planning
• System Inventory
• Remediation
• Software Development
• Technical Controls
• Procedural Controls
CIMCON’s consulting services group has extensive experience in providing 21
CFR Part 11 Compliance and Validation Services that include the following:
Planning
• Master Validation Plan(MVP)
• Risk Assessment

9. Requirements
• User Requirements Specification (URS)
Specifications
• Functional Specifications (FS)
• Standard Operating Procedures (SOPs)
Design
• Software Design Specification (SDS)
• Hardware Design Specification (HDS)
Configuration
• Hardware Configuration Specification (HCS)
• Application Configuration Specification (ACS)
Testing
• Installation Qualification (IQ)
• Opérationnel Qualification (OQ)
• Performance Qualification (PQ)
Reporting
• Summary Reports

10. Computer Systems Validation and Part 11 Assessment Experience
– Representative Systems
• Lab Equipment/Instrument Software
• Medical Devices
• Enterprise Resource Planning (ERP) Systems
• Laboratory Information Management System (LIMS)
• Quality Management Systems (QMS)
• Adverse Event Systems
• CAPA Systems
• Network Infrastructure Qualification
• Laboratory Systems
• Spreadsheet Validation
• PLC, DCS and Plant Floor Systems
• Equipment/Systems Validation
• Label Management Systems
• Manufacturing Execution Systems (MES)
• Clinical Trial Management Systems
• Source Code Reviews
• Change Management Systems
• Batch/Process Data Management System
• Database Querying and Information Retrieval
• Computerized Maintenance Management Systems
• Environmental Monitoring and Trending
• Training Systems
• HPLC Systems

11. North America (Corporate
Office)
CIMCON Software, LLC
234 Littleton Road,
Westford, MA 01886, USA
Tel: +1 (978) 464 9180
Europe
CIMCON Software (UK) Ltd
400 Thames Valley Park Drive
Thames Valley Park, Reading RG6
1PT.
United Kingdom
Tel: +44 (0) 118 466 1048
Asia Pacific Office
CIMCON Infotech Pvt. Ltd.
101, SAKAR IV, Ellisbridge,
Ahmedabad-380 006, India.
Tel: +91-79-2657 8639
CONTACTS
G E N E R A L E L E C T R I C S

12. THANK YOU FOR YOUR
TIME.