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The importance of compliance with regulations in certain areas of pharmaceutical or environmental R&D cannot be overstated. Laboratories may be subject to rules and regulations like 21 CFR Part 11, EPA CROMERR, Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
AnIML’s mechanisms, in concert with our lab data management system software, can help your organization meet these requirements to achieve complete legal and regulatory data compliance across every type of data.
In the United States, European Union and elsewhere, many labs are required to implement electronic signatures on data records. AnIML applies these signatures to the data in a standardized way.
A data format like AnIML can’t prevent unauthorized modification of a document—the owner of the underlying storage system has to set and enforce appropriate access controls and other security standards. But digital signatures can help you detect unauthorized changes. You can also use them to implement signoff workflows and multilevel approval processes in a paperless laboratory.
Users can apply multiple signatures with different scopes to an AnIML document, covering different parts of the document. This lets each person on your staff sign off on only the parts of the experiment they conducted, giving you total traceability of scientific data from long-term archival all the way back to the original instrument. In the future, each instrument might even be able to sign off directly itself on the results it produces to prove data authenticity.
The AnIML signature mechanism complies with the W3C XML Digital Signature standard, ensuring compatibility with existing public key infrastructures, certificates, key tokens and smart cards. Some jurisdictions permit the creation of legally binding signatures this way.
You can record changes to AnIML documents in the built-in audit trail. Each audit trail entry accurately records all aspects of each change:
- The old and the new values
- The person responsible
- The reason for the change
- A time stamp
You can examine these changes in the audit trail and revert the document to previous stages. For greater security, audit trail entries can be digitally signed.
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