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

LAB/INSTRUMENT FILE MANAGEMENT

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

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)

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.

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."

|

Director,

Computerized Systems Validation at Charles River Laboratories

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.

SERVICES

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.

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.

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 paperbased 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)

Design

•Software Design Specification (SDS)

•Hardware Design Specification (HDS)

Configuration

•Hardware Configuration Specification (HCS)

•Application Configuration Specification (ACS)

Specifications

•Functional Specifications (FS)

•Standard Operating Procedures (SOPs)

Testing

•Installation Qualification (IQ)

•Opérationnel Qualification (OQ)

•Performance Qualification (PQ)

Reporting

•Summary Reports

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

THANK YOU FOR YOUR TIME.