Part11Solutions – Overview

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

PRODUCTS

FORM MANAGEMENT

LAB/INSTRUMENT FILE MANAGEMENT

Digitize your Paper Forms with E-Signatures

Secure your lab/instrument files with continuous monitoring, workflow management and Part 11 compliances.

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PAPERLESS DATA INTEGRITY MANAGEMENT .

Purpose-built solution designed to help you monitor, track and manage your company's data integrity compliance status.

QUALITY MANAGEMENT SYSTEM (QMS)

TRAINING MANAGEMENT

Store all your enterprise content in one centralized repository, with a single version of the truth.

Paperless management of training records for improved compliance and productivity.

TESTIMONIALS "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

SERVICES

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.

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.

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.

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.

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.

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.

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.

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.

REPRESENTATIVE PROJECTS CIMCON’s consulting services group has extensive experience in providing 21 CFR Part 11 Compliance and Validation Services that include the following:

21 CFR Part 11 Services • Gap Assessment • Strategy and Planning • System Inventory • Remediation

• Software Development • Technical Controls • Procedural Controls

Planning • Master Validation Plan(MVP) • Risk Assessment

Requirements • User Requirements Specification (URS)

Testing • Installation Qualification (IQ)

Design

• Opérationnel Qualification (OQ)

• Software Design Specification (SDS)

• Performance Qualification (PQ)

• Hardware Design Specification (HDS)

Configuration • Hardware Configuration Specification (HCS) • Application Configuration Specification (ACS)

Specifications • Functional Specifications (FS) • Standard Operating Procedures (SOPs)

Reporting • Summary Reports

Computer Systems Validation and Part 11 Assessment Experience – Representative Systems

• Equipment/Systems Validation

• Lab Equipment/Instrument Software

• Label Management Systems

• Medical Devices

• Manufacturing Execution Systems (MES)

• Enterprise Resource Planning (ERP) Systems

• Clinical Trial Management Systems

• Laboratory Information Management System (LIMS)

• Source Code Reviews

• Quality Management Systems (QMS)

• Change Management Systems

• Adverse Event Systems

• Batch/Process Data Management System

• CAPA Systems

• Database Querying and Information Retrieval

• Network Infrastructure Qualification

• Computerized Maintenance Management Systems

• Laboratory Systems

• Environmental Monitoring and Trending

• Spreadsheet Validation

• Training Systems

• PLC, DCS and Plant Floor Systems

• HPLC Systems

GENERAL ELECTRICS

CONTACTS

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

THANK YOU FOR YOUR TIME.