One of the keys in selecting the most appropriate electronic records management software is to look for a system that meets regulatory standards required within your industry. Poplar Solutions' software has been audited and determined to meet the requirements of the regulatory agencies that governs each of our market segments.

Life Sciences

FDA regulations specifically 21 CFR Part 11 pertain to electronic records and electronic signatures, includes a requirement to validate electronic record-keeping systems to ensure the accuracy, reliability, and consistent intended performance of the system, as well as the system's ability to detect invalid or altered records.

Even though Poplar Solutions' system meets the requirements of 21 CFR Part 11, FDA compliance with this regulation is not assured until an audit is performed with the system installed in the laboratory and a determination made that all requirements are met. For many companies, the process of validating the electronic record-keeping system is likely to be complex and costly. Poplar Solutions' can significantly ease this burden through its comprehensive validation services provided through its partners and advisors. These services include:

• Full-cycle Validation - Poplar Solutions' expert partners and advisors can go onsite to conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation tests and resolve any testing deviations.

• Continuous Development - To sustain compliance, a company must make sure that its system remains in a constant state of validation. Poplar Solutions' expert partners and advisors continuously develop new methods to cut the time involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.