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The Lean Machine Software Validation |
The Lean Machine (Lean & Mean Business Systems, Inc.) database is a comprehensive integrated Quality System that incorporates electronic record keeping and electronic signatures.
The database has been indepentently validated by C&E Medical Device Consulting to ensure it meets specific requirements of the following standards:
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21 CFR Part 820 - Quality System Regulation
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21 CFR Part 11 - Electronic Records / Electronic Signatures
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ISO 13485: 2003 - Medical Devices - Quality Management System - Requirements for Regulatory Purposes
Disclaimer: Comprehensive testing of the modules was performed to verify that fields, links, reports and queries functioned satisfactorily.
This validation is provided by C&E Medical Device Consulting, Inc. "as is" and any express or implied warranties, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose are disclaimed. In no event shall C&E Medical Device Consulting, Inc. be liable for any direct, indirect, incidental, special, exemplary, or consequential damages (including, but not limited to, procurement of substitute goods or services; loss of use, data, or profits; or business interruption) however caused and on any theory of liability, whether in contract, strict liability, or tort (including negligence or otherwise) arising in any way out of the use of this software, even if advised of the possibility of such damage.
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