Moving to Electronic Lab Notebooks (ELNs) is the best way to improve the efficiency of a modern-day laboratory. This software allows you to move from manually capturing notes in a spreadsheet or word processor (or even a notebook) to using a complete software package to capture everything from research notes to reports. But data security shouldn’t be overlooked even if you’re using cutting-edge ELN solutions. When the ELNs you opt for don’t give you the proper security functionality, they could expose the data you store to third parties, including hackers.
This would mean you’re not complying with regulations when working with confidential and critical lab data. It would also expose you to compromised research integrity, errors, etc.
● Secure data storage and access controls
● Backup and disaster discovery
● User training and data ownership
● Why is are secure ELNs crucial?
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Secure data storage and access controls
When you look at the different Electronic Lab Notebooks you can choose from, it’s important to focus on the data storage solutions it uses. You need notebook software that provides a secure data storage solution. Ideally ELNs should encrypt the data with a unique code that makes it unreadable by someone trying to access it without authorization. This encryption should be active when the data is stored and transmitted.
You also need a way to control who can access different levels of data. Access controls allow you to set various levels of user authentication, such as two-factor authentication. For example, this may include the administrators, managers, and lab staff. When setting controls for lab staff, the software should also allow you to divide data into different departments. This will make tracking and monitoring actions taken by different notebook system users easier and make accessing audit trails much more straightforward.
Network security
The network security of the system you opt for is another concern to remember. This includes looking at the software’s firewall.
A firewall should have the correct configuration to guarantee that only those with the proper clearance can access the data you store on your laboratory’s ELN. This can help prevent breaches and ensure hackers can’t access your confidential data. The firewall should ideally be implemented to monitor both incoming and outgoing traffic.
Additional security measures, such as breach detection, notifications, and blocking of malicious activities and attacks, will also be helpful. The ELN should also offer regular updates to ensure that it can detect the latest threats.
Backup and disaster recovery
When a system faces issues that result in data loss, it’s vital that backups are ready to be restored once it is up again. Data loss can be extremely damaging to a laboratory and cause serious interruptions to the progress of research projects.
Ensure that the Electronic Lab Notebooks allow you to store backups on secure cold storage devices. Having backups made automatically and regularly can also be helpful.
When the ELN provider offers disaster recovery support, it will usually be able to help you regain access to critical data in case of a disaster, system breach, or other type of failure. This can minimize downtime and enable you to continue working in the lab without disruptions.
Regulatory compliance
Specific regulations come into play when looking at secure data storage in a laboratory environment. Apart from ensuring that your lab stays compliant with these regulations, you must also ensure that the ELN you choose offers compliance concerning your research area and industry standards.
For example, in the USA’s Code of Federal Regulations, Title 21 CFR Part 11, the section titled ‘Electronic Records; Electronic Signatures’ states that any notes related to patient data comply with a strict set of data privacy regulations. Ensure that your chosen ELN meets these data security and privacy requirements (as well as those applying to other regions you operate in, such as the EU).
User training and data ownership
You must ensure you provide lab staff with training to use a new ELN system easily. This means looking for Electronic Laboratory Notebook software with full support and user training.
The ELN provider must help users understand how the system works and provide extensive training data on best practices for data security. Users should be given details about the importance of strong passwords, the importance of regularly changing passwords, and how they can recognize potential attempts to infiltrate your internal systems.
Apart from offering training modules, data ownership is also essential. Ensure the software can link specific data to the user who captured it. This way, users can own their data, which can be tracked back in cases of disputes or any other problems.
Data export and sharing
Collaboration plays a vital role in a laboratory. You should also consider the data export and sharing options with an ELN.
Cloud-based ELN software allows you to share specific documents or datasheets with others. This can offer easy access to those with the link, but ensure that the software also enables you to protect the link with a password. Access control features ensure that only authorized people can open up the data you share. The system should implement appropriate data export and sharing solutions that help enforce this access control level.
At the same time, there should be a way to share data with people who do not work inside your local network. Even in this case, you need a system with policies that are easy to use, as this allows you to continue protecting the data against unauthorized access while it’s being transmitted.
Why are secure Electronic Lab Notebooks crucial?
Choosing a random ELN may cause you to miss out on important security features vital in today’s research environment. This, in turn, could lead to data breaches or even result in you losing valuable research data.
What are the potential consequences of a data breach in your lab?
Data breaches in a lab can lead to several consequences, including the following:
- A data breach can threaten trust. When partner’s and customers’ data is exposed to third parties, your lab may be seen as less trustworthy.
- Depending on the breach, your lab may face legal consequences, including penalties for not complying with specific regulations.
- Sensitive research data may be leaked to third parties who could use this information for illicit purposes.
Can you afford to lose your valuable research data?
The short answer is no. We live in a digital era and store vast amounts of data online. When you lose the data you have gathered through years of research, you have lost the time, money, and resources spent on the projects.
Are you required to comply with specific data security regulations?
Laboratories must comply with specific regulations, such as GDPR, when storing data. This includes security regulations that regulate data management and how it should be accessed. Some of these regulations include changing passwords regularly and storing user credentials safely. They also include properly storing security keys and disposing of sensitive data, if needed.
Unlock secure, compliant research with Sapio’s Cloud ELN software
Choosing a suitable Electronic Lab Notebook is a challenging task. Apart from considering efficiency, collaboration, and ease of use, you must also guarantee that your ELN is secure. Sapio’s cloud-based ELN gives you access to the latest security features while complying with the regulations set out by governing bodies.
The ELN from Sapio is ‘science aware’ and gives you access to various features that can easily help organize data, extract reports, and more. This is built upon a secure environment that uses advanced encryption technologies to keep your data secure at rest and in transit.
Sapio takes compliance seriously. The cloud ELN by Sapio adheres to several compliance standards, such as ISO 17025, ISO27001, CLIA, GLP, GMP, GCP, and HIPAA. This helps ensure your laboratory meets these standards when working with electronic data.
Additional features, such as 2-factor authentication, help to guarantee that there is a greater level of security in the system. The ELN complies with GDPR standards, ensuring privacy remains essential throughout the solution.
If you want to see what Sapio’s Cloud ELN can do for your lab, start by requesting a demo or contacting us directly with your questions.
FAQs About Electronic Lab Notebooks & Security
- What specific encryption standards are recommended for ELNs to ensure data protection both at rest and in transit?
ELNs should ideally use industry-standard encryption protocols to secure data at rest and in transit. At rest, Advanced Encryption Standard (AES) with key lengths of 256 bits is commonly recommended due to its strength and efficiency. For data in transit, using Secure Sockets Layer (SSL)/Transport Layer Security (TLS) protocols ensures that data transmitted over the internet is securely encrypted. Additionally, end-to-end encryption (E2EE) can further secure data as it moves from one point to another, making it accessible only to the intended recipient. - How does an ELN handle data breaches, and what immediate steps are taken to mitigate damage?
In the event of a data breach, ELNs should have a clearly defined incident response plan that includes immediate isolation of affected systems to prevent further unauthorized access. Notification procedures should be in place to alert all impacted stakeholders, including users and regulatory bodies, in compliance with applicable laws such as GDPR or HIPAA. The response team should assess the breach’s scope and impact, implement measures to secure data, and restore systems from backups if necessary. A thorough audit should identify the breach’s cause post-incident, and additional security measures should be implemented to prevent future occurrences. - Can ELNs be integrated with other laboratory management systems, and how does this integration impact data security?
ELNs can often be integrated with other laboratory management systems, such as Laboratory Information Management Systems (LIMS), inventory management, and project management tools, to enhance workflow efficiency and data consistency. While integration brings significant benefits, it poses potential security risks if mishandled. To mitigate these risks, it’s essential to ensure that all systems involved use compatible and robust security protocols. Regular security assessments and adherence to strict access control policies are crucial to maintaining data integrity across interconnected systems. Secure API (Application Programming Interface) practices and ensuring that all data exchanges are encrypted are key components in safeguarding data integrity during integration processes.
Other useful resources for Electronic Lab Notebooks:
- NIST Guidance for Health Care Cybersecurity: https://www.nist.gov
- FDA’s Data Integrity and Compliance with CGMP: https://www.fda.gov/files/drugs/published/Data-Integrity-and-Compliance-With-Current-Good-Manufacturing-Practice-Guidance-for-Industry.pdf
- HIPAA (Health Insurance Portability and Accountability Act):https://www.hhs.gov/hipaa/for-professionals/security/laws-regulations/index.html
