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DaCS™ was the 1st and is the leading 21 CFR Part 11 compliant solution for Excel spreadsheets. Introduced in 2001, DaCS™ is a mature product and has been implemented in the leading clinical research and pharmaceutical manufacturing companies worldwide. Industry leading consultants and regulators consistently rate DaCS™ as the solution of choice, providing more flexibility, superior support and unrivalled compliance. |
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 DaCS™ is supported globally by ABB Engineering Services. ABB operates in 113 countries worldwide and offers support contracts and support services wherever you may be located. We offer the convenience and dependability of local delivery with global support services that meets the international nature of your business.
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DaCS™ now contains in-built audit trail interrogation tools, allowing you to search, filter, display and export only the audit entries you or your regulator needs. This allows you the benefit of quicker and more efficient data review and improves compliance confidence. |
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DaCS™ does not add macros to every spreadsheet. DaCS™ functionality is contained in the DaCS™ program, not transferred into each and every spreadsheet.
If you insert macros into each spreadsheet you make each spreadsheet more customised and have to increase your validation effort on every single spreadsheet (GAMP category 5).
If you insert macros the macros will/may interact with any macros or functionality in the original spreadsheet and additional validation will be needed to ensure there are no conflicts.
The major goal for spreadsheet validation should be to keep the spreadsheet validation effort to a minimum, as most clients will have multiple spreadsheets to validate and that is very time consuming. We have developed a cost effective methodology to validate the application once, and minimise the validation of each spreadsheet. |
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DaCS™ uses randomly generated passwords to protect controlled workbooks. These passwords are changed every time the controlled file saves or closes. This is a crucial security feature to ensure the security of your electronic record, after all your files are only as secure as the passwords used to protect them. We do not believe that the whole integrity of your record should be based upon a single password that can be easily determined. DaCS™ provides compliance peace of mind. |
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The regulators insist that you can prove the authenticity and integrity of your files and data. DaCS™ forces you to save a controlled file on closing, applying a digital signature to the file to uniquely identify its content. Upon reopening the controlled file DaCS™ verifies that the digital signature is still valid and that the file has not been modified. This is a crucial data authenticity and integrity check unique to DaCS™. |
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DaCS™ allows you the convenience to opening more than one controlled spreadsheet simultaneously, this is common practice in native Excel and something DaCS™ allows you to perform unrestricted.
A large proportion of spreadsheet work involves using multiple sheets at once or linking to other sheets. |
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DaCS™ controlled workbook are portable, they can be opened and used by other DaCS™ users, whilst non DaCS™ users can view them (read only) using Excel. The recipients don’t have to be on the same server, network, or even in the same company or country to benefit from portable file sharing. There is no need to convert your files into read-only format or to take on the risks involved in making multiple copies of the same electronic record. |
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DaCS™ supports direct interfacing with instrumentation and other computer systems allowing you to control and capture data direct from other systems in a secure and controlled manner. For example you can connect an instrument to your PC’s serial port, or connect to a database and then capture data directly into a DaCS™ controlled spreadsheet. Your captured data would have logical security, audit trail and be Part 11 compliant. The possible applications for this functionality are endless.
See here for more information on these unique new features within DaCS™. |
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The security of DaCS™ controlled files cannot be “turned off” by users. DaCS™ controlled files have the controls securely housed within the files, there are no user accessible options such as File properties, Custom properties or the ability to disable macros once within the application.
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