***READ FULL DESCRIPTION BEFORE BIDDING OR YOU WILL NOT BE CONSIDERED***
REQUEST FOR PROPOSAL FOR SOFTWARE DEVELOPMENT
The software requested will be utilized by pharmaceutical and biotechnology companies for the finishing and validation of SPL labeling. The software should run on a desktop and have two functions; finishing the SPL/XML code and validating the SPL code versus the FDA provided checklist.
The software finishing should involve insertion of GUID values at appropriate places in the XML file and perform a spell check of the text. If the labeling is the first for the drug product then the “setId” should be populated with a new GUID otherwise the “setId” GUID should not be updated. All other instances for the “id” tag should be populated with a new GUID value
The validation portion of the software should validate the XML file against the appropriate schema, the LOINC values (codes, code system, display name and system name – available from the FDA website), and follow the FDA ELIPS validation guideline ([url removed, login to view]). Upon completion of the validation the software should prepare a log file with the results of the validation. The log file should be formatted similar to the FDA guideline.
The final version of the software should include an installer and require an activation code if used for more than two weeks, the ability to register the software would be nice.
The deliverables associated with this project are as follows:
• Design version of software for testing by US during applicable preparation of software
• Beta Version of software in near final format for testing by US during applicable preparation of software
• Final version of software, including installer, requirement for activation code and demo code capabilities
• Final software code
Rights in Work Product
WE will own all right, title and interest in all software, code, inventions, discoveries, product designs, know-how, formulas, ideas, documents, publications, and the like or other information conceived, prepared, created and compiled during the term of the software development services agreement. The developer agrees to assign and hereby assigns to US all copyrights, patents, trademarks, or other intellectual property of any kind arising from the work performed under this Agreement, which will be the sole property of Company, including all rights to reproduce and distribute. The developer shall promptly disclose any such intellectual property to Company and assist US in applying for, maintaining, or otherwise securing legal protection for the same, and the developer agrees to execute any papers, documents or letters necessary to vest title in the intellectual property in Company.
Please provide the following with your proposal:
• Brief introduction to your background (i.e. resume)
• Description of software development plan
• Proposed project timeline
• Project cost
• Acknowledge agreement with right in work product clause