FDA Compliant Thermal Analysis Software for the Pharmaceutical Industry

摘要

The U.S. Federal Food and Drug Administration (FDA) has issued regulations that providerncriteria for acceptance by the FDA, under certain circumstances, of electronic records andrnelectronic signatures as equivalent to paper records and handwritten signatures executed on paper.rnThe aim of the regulation is to ensure the integrity, trustworthiness and reliability of electronicrnrecords and, where used, electronic signatures. The Electronic Records and ElectronicrnSignatures final rule (FDA 21 CFR Part 11) became effective on August 20, 1997. All systemsrnthat come under FDA regulations are impacted by the regulation.rnPart 11 requires three types of controls: Administrative controls, e.g. policies such asrnidentification of individuals and non-repudiation of electronic signatures, procedural controls,rne.g. Standard Operating Procedures for using and maintaining a system and technical controls,rne.g. security and access to the application and audit trails.rnThese procedures may also apply to thermal analysis investigations like determination ofrnmelting point, purity or moisture content. Therefore, a software tool was developed to ensure thatrnthe technical controls are compliant. The STAR~e software has been designed to work as a closedrnsystem featuring:rn1. Access Control to the application (password)rn2. User Level Management (user rights)rn3. Electronic Records (file integrity)rn4. Audit Trail (change and system history)rn5. Electronic Signatures (status of electronic records)rnThe main principles of Part 11 and solutions for the instrument relevant technical control are discussed.