Our advanced digital signature solution provides full traceability within the signed document by using the established PDF format (ISO 32000) to ensure that changes to electronic data and signatures are traceable and that every activity related to electronic signatures and records is documented. This ensures that electronic records and electronic record signatures are recognized in accordance with FDA Part 11 requirements and other regulatory standards.
Hamilton adheres to industry best practices for system operation of the infrastructure on which, among other things, digital signatures are used and digitally signed documents are stored and archived. Only Hamilton internally operated systems are involved in the file storage process as well as the signature process. In addition, processes are implemented in the quality management system (ISO 9001 and ISO 13485) as well as in the information security management system (ISO 27001), which regulate the continuity management and system monitoring of the systems involved.
The Hamilton signature solution can only be used by persons who have been identified, authorized and trained by Hamilton. The PDF standard defines the technical procedure for signing documents. The technical implementation makes it possible to identify the signatures embedded in the document beyond doubt and to prove mathematically that the document as well as the signatures have not been altered. These signatures are also provided with a referenced, signed time stamp that cannot be influenced by the user. This originates - if available - from an external, trusted time reference or from the local PC, in which case corresponding information is stored with the signature in the case of the latter.
The implementation allows to prove comments and inputs made after the digital signature(s) of a document. The system's audit trail also makes it possible to determine who made which change.
Changes to document content demonstrably invalidate signatures.