Paperless Manufacturing Systems Comparisons

Paperless manufacturing applications can reduce cycle times by eliminating time for collection and review of paper documents and by reducing costs for producing, storing, coping paper documents. They can reduce the cost of compliance by automating quality requirements and allowing records and deviations to be reviewed in real time. .Mostly they can increase the speed of process development and production because electronic batch records are easy to update, easy to transfer, easy to use and easy to review.

CIMx Software – Interax Suite:
This is a suite of paperless manufacturing products. The Author module creates work instructions and routings. This module has options for attaching information to the work instructions, for editing and formatting the instructions and for the use of Microsoft Word or Excel within the instructions. All information that users need is electronically linked to a work instruction package. The Work Assistant module provides the user with the information required to do their job on a single, easy to read screen. Since this application is not 21 CFR Part 11 compliance, it may not meet the needs of all pharmaceutical manufactures.

Kneat Gx:
Kneat Manufacturing™ is the most flexible approach to paperless manufacturing yet. It delivers a large proportion of manufacturing execution system (MES) for a fraction of the cost. It has been designed to simplify the documentation processes associated with manufacturing and batch production. A key feature is the batch or device history record can be automatically generated on creation of the batch or lot number. All associated forms from bill of materials, inventory requests, specifications, QC inspections, etc, can also be created at the same time so that they are available and easily accessed by operations personnel when required. The system has been validated to 21 CFR Part 11 requirements.

Paper-Less MES:
Paper-Less, LLC designs, develops, markets and supports manufacturing software for shop floor and warehouse applications. Their solutions are configurable and adaptable to shop floor environments where they are easy to learn and easy to use. Paper-Less MES is designed to control, integrate and create on-line visibility into Work in Process (WIP) functions including scheduling, shop packets, production management and labor reporting. It also handles quality testing, non-conformance notifications, inventory transactions and time card management. It is not specifically designed for pharmaceuticals, but it could be adapted. Non-compliance with 21 CFR Part 11 could be an issue.

InstantGMP™:
Instant GMP™ is a web-based Part 11 compliant manufacturing execution system for that streamlines the entire process of pharmaceutical manufacturing. It simplifies the documentation and approval procedures to reduce production times. It comes pre-packaged with all the standard operation procedures for manufacturing. The application includes material management with version control, room and equipment logs, specification control with version control, inventory control, Master Batch Records with version control, Batch Manufacturing Records, security and audit logs. It can be accessed remotely from any location and has security settings on each screen. It is 21 CFR Part 11 compliant and a validation package is available to its users.

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