Specifications include, but are not limited to: 1. Provide a Quality Control Software solution which: a. Includes track document management with indexing and revision tracking.; b. Automatically archives old versions of documents to prevent use of outdated policies and procedures. ; c. Views and searches document changes.; d. Tracks training, competency, and proficiency testing for all areas of HETL, with accessibility to monitor overdue verses coming due items.; e. Tracks corrective action and non-conforming work processes and workflows.; f. Customizes and assigns workflows to all processes, allowing individuals to stay on task, for the completion of required tasks, including: i. Training, ; ii. Corrective actions and deviations, ; iii. Customer complaints, ; iv. Validation, ; v. Onboard training, ; vi. Safety training, ; vii. Equipment monitoring, ; viii. Audits, and ; ix. Annual document review. ; g. Imports accreditation standards and tags documents to specific standards to assist with objective evidence required for internal and external audit processes.; h. Incudes a gap analysis when new accreditation standards are issued to assist the lab in determining areas that need to be addressed and improved.; B. Initial Setup and Support: 1. Complete product installation with all laboratory accreditation standards incorporated into the software upon delivery, within one (1) month from date of purchase. Required accreditation standards include: a. Clinical Laboratory Improvement Amendments (CLIA); b. ISO/IEC 17025:2017; c. U.S. Environmental Protection Agency (U.S. EPA); d. Maine Laboratory Accreditation Program (MLAP) ; e. AIHA Laboratory Accreditation Programs (AIHA LAP, LLC); 2. Provide training and customization following the installation of the Quality Control Software solution to HETL staff within twelve (12) months from date of purchase.; a. Train HETL staff in operating the software and in assisting with implementation in order to provide full implementation to HETL. ; 3. Provide dedicated support from a product specialist during the entire installation, training, and implementation period.; 4. Provide assistance identifying and customizing software, notifications, and workflows for the clinical, forensic, environmental, and shipping and receiving areas of the laboratory.; 5. Provide access to training materials for HETL staff.; 6. Provide assistance importing documents to the software during the installation, training, and implementation period.; 7. Provide 24/7/365 customer service support following installation of the Quality Control Software solution and during the contract periods.; 8. Provide a dedicated account manager during the contract periods.; 9. Provide notification of product updates and assistance with implementation and troubleshooting during the contract periods.; 10. Provide user control access to all items within the system, controlling read versus edit access, upon all users within the system.
