Excel Spreadsheet Validation for 21 CFR Part 11 Compliance

Healthcare companies regularly use Microsoft Excel spreadsheets for GxP purposes, whether as an operator interface, as a data manipulation tool, or for data storage.
ABB Engineering Services and Compassoft have come together to offer
technology and services that deliver fully compliant spreadsheet solutions.

DaCS™ for MS Excel

21 CFR 11 requirements.

DaCS™ was the first commercial product specifically designed to address Part 11 issues with Microsoft Excel. Introduced in 2001, DaCS™ has been implemented in the leading clinical research and pharmaceutical manufacturing companies worldwide. DaCS™ is consistently rated by industry and consultants alike as the solution of choice, providing more power, more flexibility, and better compliance than our competitors. Find out more.

Current DaCS™ Version: DaCS™ 1.3.35 provides

The ability to continue to use the convenience and common functionality of Excel in a compliant regulatory environment.

Users of Excel can be given access to DaCS™ controlled files whereupon the user will be able to open and read the data, but not make any modifications.

The ability to import your current spreadsheets into the secure DaCS™ environment with no or minimal modification. Often all that is needed is the application of ABB spreadsheet best practice to provide you with a consistent and easy validate format.

Logical security features that control access to DaCS™ and to each individual spreadsheet.

The ability to execute secure electronic signatures within individual workbooks, eliminating the need for signed paper copies.

A fully independent audit trail recording what, when, and by whom changes are made. The audit trail is securely incorporated within individual workbooks, allowing complete portability without losing the traceability of the workbook's history.

Simple integrated Excel configuration tools allowing the administrator options such as password requirements, file locations, security checks, and entry and signature meanings.

A standard software solution (GAMP category 3) that provides full 21 CFR Part 11 compliance, removing the need for individual spreadsheet VBA customisation.

Featuring-

* Move, Copy, Insert, and Rename Sheets in DaCS™-Controlled Workbooks.
* Improved Workbook and Sheet Protection Options.
* Faster and Easier Conversion of Legacy Workbooks.
* Support for international versions of Excel.
* Easier installation and administration- one executable supports Excel 97, 2000, XP
* Enhanced, easier-to-use audit trail input form, and audit trail interrogation tools.
* Audit trail capture of number formats
* Secure instrument control mode, for both laboratory instruments and external software packages providing unique connectivity and interfacing capability with other systems
* Secure 'user aliasing' capability, allowing user logins to be "passed" into DaCS™
* Worldwide support contracts and service by ABB Engineering Services
* Programming manuals and object model documentation
* Other enhancements based on three years of broad field experience, something no other competitor can claim!

Download the fully functional demo version for free!

Compare DaCS™ to the competition; we're confident that it will continue to come out on top. You'll need to register with us to get the installer password.

The DaCS™software is provided as off-the-shelf software from ABB Engineering Services. Configuration and customisation are optional, but very possible. the software is provided under the DaCS™ End User License Agreement (EULA)




		Technical Details and Description of DaCS™

	Healthcare companies regularly use Microsoft Excel spreadsheets for GxP purposes, whether as an operator interface, as a data manipulation tool, or for data storage. ABB Engineering Services and Compassoft have come together to offer technology and services that deliver fully compliant spreadsheet solutions. DaCS™ for MS Excel 21 CFR 11 requirements. DaCS™ was the first commercial product specifically designed to address Part 11 issues with Microsoft Excel. Introduced in 2001, DaCS™ has been implemented in the leading clinical research and pharmaceutical manufacturing companies worldwide. DaCS™ is consistently rated by industry and consultants alike as the solution of choice, providing more power, more flexibility, and better compliance than our competitors. Find out more. Current DaCS™ Version: DaCS™ 1.3.35 provides The ability to continue to use the convenience and common functionality of Excel in a compliant regulatory environment. Users of Excel can be given access to DaCS™ controlled files whereupon the user will be able to open and read the data, but not make any modifications. The ability to import your current spreadsheets into the secure DaCS™ environment with no or minimal modification. Often all that is needed is the application of ABB spreadsheet best practice to provide you with a consistent and easy validate format. Logical security features that control access to DaCS™ and to each individual spreadsheet. The ability to execute secure electronic signatures within individual workbooks, eliminating the need for signed paper copies. A fully independent audit trail recording what, when, and by whom changes are made. The audit trail is securely incorporated within individual workbooks, allowing complete portability without losing the traceability of the workbook's history. Simple integrated Excel configuration tools allowing the administrator options such as password requirements, file locations, security checks, and entry and signature meanings. A standard software solution (GAMP category 3) that provides full 21 CFR Part 11 compliance, removing the need for individual spreadsheet VBA customisation. Featuring- * Move, Copy, Insert, and Rename Sheets in DaCS™-Controlled Workbooks. * Improved Workbook and Sheet Protection Options. * Faster and Easier Conversion of Legacy Workbooks. * Support for international versions of Excel. * Easier installation and administration- one executable supports Excel 97, 2000, XP * Enhanced, easier-to-use audit trail input form, and audit trail interrogation tools. * Audit trail capture of number formats * Secure instrument control mode, for both laboratory instruments and external software packages providing unique connectivity and interfacing capability with other systems * Secure 'user aliasing' capability, allowing user logins to be "passed" into DaCS™ * Worldwide support contracts and service by ABB Engineering Services * Programming manuals and object model documentation * Other enhancements based on three years of broad field experience, something no other competitor can claim! Download the fully functional demo version for free! Compare DaCS™ to the competition; we're confident that it will continue to come out on top. You'll need to register with us to get the installer password. The DaCS™software is provided as off-the-shelf software from ABB Engineering Services. Configuration and customisation are optional, but very possible. the software is provided under the DaCS™ End User License Agreement (EULA)