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Speed Electronic Regulatory Submission and Review through Digitalization of Lab Processes
Selecting the right Electronic Lab Notebook (ELN) to meet the complex needs of your scientific laboratory can be a challenging task. There is a clear and present need to move from paper-based to paperless but that is just the beginning. Its important to understand the goals for this transformation – the greater vision that will define future success for the business.
Transition can be a good opportunity to simplify things and try to figure out how to further optimize your processes and streamline the overall lab data management system once everything is digitized and traceable.
To prepare for your vision of the digital future, here are three target areas that the SciNote Electronic Lab Notebook (ELN) will enable big gains in accelerating scientific innovation:
1. The end of the paper lab notebook
the laboratory research notebook is often considered one of the most important tools in the scientific industry. It serves as a permanent, legally defensible record of the experimental process and intellectual property. Due to the critical nature of the scientist’s work, the transfer of these paper-based records to an electronic format is a difficult challenge for many labs and remains one of the final frontiers of digital transformation within an organization.
Electronic Lab Notebooks (ELNs) are the new digital version of the traditional lab notebook that allow a researcher to efficiently track and organize all information relating to each experiment in a digital record, allowing for secure inventory and data management, ease of accessibility, advanced search and filter options, and collaboration.
Choosing the best ELN for your laboratory environment can offer significant productivity benefits over traditional notebooks. The SciNote Electronic Lab Notebook, selected as the trusted ELN solution by the FDA and NIH, have reportedly saved researchers an average of 9 hours per week. Increased efficiency estimates include:
- Data research: 90% faster with fast search through all data.
- Reporting: 90% faster as SciNote automatically generates project reports.
- Templates: 80% faster with templates to replicate processes and experiments
2. Modernize your approach to regulatory compliance
The current regulatory landscape centers around traceability (the ability to reconstruct the development history of a product) and accountability (the ability to resolve who has contributed what to the development and when). Documentation management is a critical aspect of the GxP guidelines and documentation compliance may soon result in excessive paperwork. Many hurdles related to the documentation management can be mitigated with the use of an electronic lab notebook (ELN) that offers the essential functionalities which fulfil the requirements of the GxP guidelines and facilitate its implementation within your organization.
SciNote Premium provides a 21 CFR Part 11 toolset for compliance with the 21 CFR Part 11 regulations which includes: electronic signatures, electronic witnessing, audit trails and system log records. According to the FDA guidelines, electronic signatures are considered to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures if necessary.
Each electronic signature is unique to one individual person. It is based on a combination of the individual’s e-mail and password, and cannot be reused or reassigned to anyone else. Electronic signature record provides the date and time when the signature was executed.
It is important to emphasize that an ELN itself, as well as any other software or tool, cannot be certified to be GxP compliant. This is because the compliance does not solely depend on the software system or tool you use, but mostly on how diligently the processes and procedural controls (e.g., document control, SOPs, training etc.) are implemented and handled by the organization, which uses electronic data, electronic records that are generated in an ELN or other software tools.
3. Speed Electronic Regulatory Submission and Review
Laboratories are adopting digital tools to manage projects, inventory, and data. With regulatory bodies, including the FDA, now accepting electronic records, digitalization of lab practices will only grow, and will benefit those who can successfully implement it.
SciNote ELN can transform your processes by helping to ensure regulatory compliance, maintain quality control, and manage your workflow to more efficiently achieve governmental digital document standards, collaborate seamlessly with other stakeholders, and digitally document results with 21 CFR part 11 compliant electronic signatures and audit trails.
An important factor to consider when selecting an ELN is the support you will receive in the implementation stage. To this end, SciNote provides top-rated customer support and onboarding experience; its Customer Success Team will guide you through the transition to ensure a successful implementation. This alleviates any uncertainty associated with the transition, and reduces the length of your implementation stage, allowing you to take full advantage of all the benefits SciNote ELN can offer much faster
True digital transformation is achieved through the digitalization of lab processes, from beginning to end. Evaluate the pain points, the rate-limiting steps that currently exist and identify areas of improvement where manual intervention can be eliminated, and digital efficiencies can be gained. SciNote’s functionalities speed time consuming tasks by eliminating paper-based records and bringing workflows up to pace with the digital age to drive digital efficiency in the electronic regulatory submission and review process for new medicines and accelerate scientific innovation.
Why it Matters for You
In this blog we discussed:
- How many hurdles related to the documentation management can be mitigated with the use of an electronic lab notebook (ELN) that offers the essential functionalities which fulfil the requirements of the GxP guidelines and facilitate its implementation within your organization.
- SciNote ELN has reduced time consuming tasks in the laboratory by an average of 9 hours per week while increasing efficiency by as much as 90% in data research and reporting.
- Using SciNote ELN can speed the electronic regulatory submission and review process by helping to ensure regulatory compliance, maintain quality control, and manage your workflow to more efficiently achieve governmental digital document standards and compliance with 21 CFR part 11 electronic signatures and audit trails.
For over 25 years, Astrix has been a market-leader in delivering innovative solutions through world class people, process, and technology that fundamentally improves scientific outcomes and quality of life everywhere. Founded by scientists to solve the unique challenges life sciences and other science-based business face. Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations