DaCS
Desktop Spreadsheet Control and FDA 21 CFR Part 11 Compliance
DaCS provides a seamless infrastructure for MS Excel to meet regulatory compliance requirements through its detailed change history, audit trail, security enhancements, and electronic signature capabilities.
DaCS was the first commercial product specifically designed to address FDA 21 CFR Part 11 compliance issues with Microsoft Excel. Introduced in 2001, DaCS has been implemented by many of the leading clinical research, pharmaceutical manufacturing, and other companies worldwide to bring their critical spreadsheets under control.
Key features of DaCS include:
- The ability to continue to use the convenience and common functionality of Excel in a compliant regulatory environment.
- Non-intrusive solution allows users of Excel to be given access to DaCS controlled files such that the user will be able to open and read the data, but not make any modifications.
- Easy to implement, including the ability to import your current spreadsheets into the secure DaCS environment with no or minimal modification.
- Increases security of critical business information through logical security features that control access to DaCS and to each individual spreadsheet.
- Provides accountability framework including the ability to execute secure electronic signatures within individual workbooks, eliminating the need for signed paper copies.
- Creates robust documentation with a fully independent audit trail recording who, when, and what changes are made that is securely incorporated within individual workbooks, allowing complete portability without losing the traceability of the workbooks history.
POWERFUL SPREADSHEET CONTROL
End-user applications such as spreadsheets are everywhere within your company — and in today’s distributed computing environments, they may be literally anywhere in the world. They may also be interconnected with other applications, inside and outside the company, in ways that virtually no one understands. And that means they lie outside your company’s established chain of accountability. These uncontrolled applications are an open invitation to human error, simple negligence — and deliberate fraud. If they remain uncontrolled, they can expose your company to regulatory sanctions, legal liability, and worse.
FINSBURY SOLUTIONS
Finsbury Solutions award-winning technologies give you easy-to-use yet powerful automated tools for managing the unrecognized risks your company faces every day. These risks are hidden in the thousands of pieces of unmonitored data in your company’s networks and on your employees' desktops and notebook computers. Finsbury Solutions' software discovers, validates and controls these masses of information, keeping you in compliance with regulatory mandates such as Sarbanes-Oxley and the FDA's 21 CFR Part II, and reducing the risks of accounting errors and fraud.
DACS AUDIT LOGGING AND CONTROL
DaCS™ provides a seamless and embedded infrastructure for MS Excel® spread-sheets to meet regulatory compliance requirements through its detailed change history (audit trail), security enhancements, and electronic signature capabilities.
DaCS was the first commercial product specifically designed to address FDA 21 CFR part 11 and Sarbanes-Oxley regulation non-compliance issues with Microsoft Excel. Introduced in 2001, DaCS has been implemented by more than sixty leading clinical research, pharmaceuti-cal manufacturing, and other companies worldwide to bring tens of thousands of spreadsheets under control. 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.
PRODUCT FEATURES
- Provides 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.
- Enhanced, easy to use audit trail input form, and audit trail interrogation tools.
- Granular access and flexibility for actors based on roles and security level – all the way down to an Excel viewer- only capability for Downstream Consumers
- Unique "instant replay" and comparison of workbook history without needing prior versions
- Complete file portability allows remote and mobile users, or even people at other companies, to use workbooks with the full security and auditing features of DaCS.
- Import function for current spreadsheets into the secure DaCS environment with no modification.
- Security features that control access to DaCS and to each individual spreadsheet, including tamper-detection and forensic analysis technology to defeat hacking and fraud.
- Execution of secure electronic signatures within individual workbooks, eliminating the need for signed paper copies.
- Identity management through Finsbury Solution’s lightweight PKI, or integration with third-party PKI standards such as SAFE, Cybertrust, or Identrus.
- Secure 'user aliasing' capability, allowing user logins to be securely "passed" into DaCS from third-party systems.
- Simple integrated Excel configuration tools allowing the administrator options such as password requirements, file locations, security checks, and entry and signature meanings.
- Unparalleled programming capabilities allow for easy integration with third-party systems.
- Compatible with most commercially available document management systems.
PRODUCT BENEFITS
- Provides the ability to continue to use the convenience and common functionality of Excel in a compliant regulatory environment.
- Non-intrusive solution allows users of Excel to be given access to DaCS™ controlled files such that the user will be able to open and read the data, but not make any modifications.
- Easy to implement, including the ability to import your current spreadsheets into the secure DaCS™ environment with no or minimal modification.
- Increases security of critical business information through logical security features that control access to DaCS™ and to each individual spreadsheet.
- Provides accountability framework including the ability to execute secure electronic signatures within individual workbooks, eliminating the need for signed paper copies.
- Creates robust documentation with a fully independent audit trail recording who, when, and what changes are made that is securely incorporated within individual workbooks, allowing complete portability without losing the traceability of the workbooks history.
- Simple operation through integrated Excel configuration tools, allowing the administrator options such as pass word requirements, file locations, security checks, and entry and signature meanings.
ABOUT FINSBURY SOLUTIONS
Finsbury Solutions enables you to manage your company’s risk, with industry-leading software tools that integrate simply and rapidly with your IT infrastructure. Finsbury Solution's technologies are currently deployed by accounting departments to meet general accounting and audit controls, by compliance departments to address mandates such as Sarbanes-Oxley and FDA 21 CFR Part 11, and by IT departments for impact management and dependency management.
