Are Digital Signatures Accepted by Laboratory Regulators? Best Practice ELNs Ensure Validity

Digital Solutions

As laboratory scientists, we are engaged in producing results and drawing conclusions that can potentially impact daily life on our planet. Because of the significant effects that our results can have, it is important to maintain scientific integrity over the entire process, from hypothesis formation to the review and approval of experimentation. It is out of concern for this integrity that many laboratory managers have concerns whether a digital signature within an electronic laboratory notebook (ELN) is as valid as a wet signature.

This is not the first time that people have questioned the integrity and identity of the individual behind a signature. For centuries, people have attempted to create different ways to establish identity and ensure integrity. In ancient Babylon, merchants implemented the first handshake as a symbol to imply that a deal or contract had been agreed. People who violated the agreement lost their integrity. As society evolved, we began to develop tokens, seals, and signatures as means to establish the validity of items.

In the laboratory, scientists began to adopt both the laboratory notebook and the handwritten signature at about the same time. Ultimately, it became customary for scientists to sign or initial each page of a notebook to indicate that they had created the document and that all of the information on each page was accurate and true.

A full digital solution complete with digital solutions is possible, as long as you follow the rules.
With digital Equipment, many laboratories have adopted a “cut-and-paste” documentation model, instead of a full digital model with secure digital signatures.
Image source: Gregory I. Lang from Wiki Commons

In today’s laboratory environment, handwritten notebooks and signatures have become cumbersome and difficult to manage since most of the equipment has gone digital. Some organizations have responded by adopting a hybrid digital model, which involves printing electronic records, pasting them into a laboratory notebook, and then signing the notebook. However, this process increases the total amount of time scientists spend on administrative tasks. Thus, many lab managers are looking to implement a full digital solution, but hesitate out of concern for scientific integrity.

Fortunately, the legal and regulatory bodies have issued some guidance around the use of digital signatures including the following:

21 CFR Part 11 – The Food and Drug Administration (FDA) originally issued this regulation in 1997, and updated it in 2003 and 2007. The regulation outlines under what circumstances a digital signature and electronic submission will be accepted by the FDA. The rules, designed to ensure user identity, include the implementation and monitoring of system controls, audit trails and regular audits to verify system integrity.

1999/93EC – The European Parliament issued this directive in December of 1999. It is specifically focused on the legal recognition of electronic signatures through a certification service. According to the directive, a digital signature must by uniquely linked to a signatory, capable of identifying the signatory, created solely by the signatory and any underlying data created by the signatory must be linked back to the digital signature, usually through audit trails.

Based on these and a number of similar laws, government and regulatory bodies will accept digital signatures as long as the identity and integrity of the person can be verified through a unique username and password, various system controls and audit trails that link data to the person that created it.

For lab managers who are looking to implement a digital laboratory notebook that will be accepted as a laboratory or business record, it’s important to verify with vendors whether or not their products take into account the above mentioned laws. ELNs that meet the requirements outlined within the laws will be supported in court and accepted by regulatory organizations. If an ELN cannot meet these requirements, the integrity of the digital signature cannot be assured.

The Accelrys Notebook offers a fully supported digital signature solution compliant with all the applicable laws, allowing lab managers to remain confident that intellectual property will be both recognized and protected. For more information regarding the full line of Accelrys ELNs, please visit our website today.

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