Demystifying Digitalization Of Laboratories

Demystifying Digitalization Of Laboratories

Manual processing in most the reputed laboratories is giving way to automated and integrated applications, paving the way towards a complete digitalization of data handling, testing and experimentation, and report generation.

Agaram Technologies offers a diverse array of laboratory digitalization solutions such as ELN, LIMS, SDMS, Interfacer and DMS which cover a wide range of lab processes across many industries.

Nonetheless, there are numerous apprehensions being faced by professionals desiring to pioneer the digitalization of their laboratories.

Despite apprehensions, the topic of digitalizing libraries efficiently is at the forefront of discussions among various lab managers. New and smarter technologies are already available.

Most of the laboratories desiring digitalization have the following objectives:

  • Achieve quicker, reliable, and error-free operations and results
  • Produce superior quality results.
  • Improve data integrity
  • Optimization of existing workflows.
  • Greater data security.

What factors should you consider to successfully digitalize your laboratory? Here is an approach you can follow.

Audit the current state of your laboratory

For every successful strategic implementation, it is crucial that you know your current state. How do various processes inside your laboratory work? How are the data flows defined, or how is your data captured, stored, and processed?

It will also help you if you prepare the list of infrastructures such as the various instruments at your premises, any robotic devices that you’re using and the level of current digitalization.

Take note of how you record and process data and how you would like it to be measured after the completion of the digitalization process. What are going to be your KPIs? Are you in need of fulfilling any regulatory compliance? Some of these may include 21 CFR Part 11, EU GMP Annex 11, ISO standards, HIPAA compliance, and GDPR.

Are there some stipulated obstructions on the way to digitalization that you must take into consideration? What probable bottlenecks you may face?

The more detailed your audit is, the better prepared you will be.

Decide which aspects of your laboratory you want to digitalize

You can decide the level of digitalization you want to carry out. It doesn’t need to be 100%. There are many factors that have an effect on how much you want to digitalize and how much time it is going to take. You can set a timeframe. You can set an aspect or a component of your laboratory that you want to digitalize. You can talk to our consultants to evaluate your current needs and the best way forward. These are the areas you can consider for digitalization:

  • Customer service.
  • Research and operations.
  • Organizational structure.
  • Product development.
  • Compliance.

Assign the task of laboratory digitalization to a dedicated team

A dedicated team will make sure that everything works on time and as per schedule. Digitalization doesn’t just mean technology; it also means a culture that motivates people to embrace digitalization.

There must be an action strategy. There must be a chain of command. Certain people must be assigned specialized tasks. Goals and steps must be clearly defined. Complex tasks must be broken into smaller, simpler tasks that can be easily implemented in stages and their performance can be evaluated.

If external help is required, for example, if you need to work with a team like Agaram, you shouldn’t resist the idea because such teams have extensive experience helping laboratories with digitalization.

Agaram Technologies’ vast experience in implementing highly complex projects across various geographics will help to successfully to achieve the digitization of laboratory process The proven project management methodology adopted by Agaram Technologies with the deployment of project managers, consultants, quality assurance engineers, Technical developers, right from requirement gathering phase till go-live and support phase will ensure scientific approach in a collaborative and coordinated manner

Explore the existing solutions

Some excellent solutions for digitalizing laboratories already exist. Many Laboratories have already been digitalized.

Many laboratories have already been digitalized. There are hundreds of case studies available online and in the publically available archives.

Agaram’s Qualis LIMS provides laboratories with features to manage samples, projects, tests, methods, specifications, registrations, scheduling, results, approval workflows, inventory, instruments & reports. It will also help to comply with GxP, data integrity, 21 CFR Part 11 & ISO 17025.

Logilab SDMS will ensure the capture, archive, and retrieval of any instrument data. It enables to building of a single source of truth for raw & metadata for instrument & human-generated data. It enables automation, 21 CFR Part 11 compliance & data integrity for the labs

Logilab ELN is a user-friendly generic electronic lab notebook to transform quality & research labs paperless. It provides features namely configure templates, test method execution, research data capture, analytics, protocol management, inventory & dynamic reporting.

Qualis Document Management System ensures secure documentation with controlled distribution to end-users. It provides workflow-based document approval with revision control.

Agaram’s Interfacer middleware is a configurable In Vitro Diagnostic which will easily integrate instruments with LIS, LIMS, HIS, EMR, ELN, MES systems seamlessly for automation and error-free operations

You can create a pilot project for digitalization

As already mentioned above, you don’t need to dive 100%. High stakes may be involved when you are planning to digitalize your laboratory and many operations may be obstructed when the work of digitalization is going on. Instead, you can create a pilot project. Choose a particular aspect of your laboratory that can be digitalized without obstructing other aspects, and work fully on it. This will not only digitalize a crucial part of your laboratory, it will also help you create a case study and a template that then you can use for implementing digitalization in other aspects.

Define clear milestones and deliverables

Once you have worked on your pilot project you need to analyze how much has been achieved. This analysis can be done at different stages of digitalization whether you are digitalizing one aspect of your laboratory or multiple aspects. You can set short-term and long-term milestones in KPIs.

Working in the lab, you are already handling vast swaths of data. Number crunching is never a problem with you. You just need to correlate with the performance of your digitalization campaign.

Are you experiencing efficiency and accuracy? Is your data better protected? Has the level of communication improved? Are you able to generate transformational reports? How fast is the turnaround time? These milestones can help you gauge the success of your laboratory digitalization campaign.

Conclusion

The digitization of the lab involves turning paper-based/analog information into a digital format. In practice, this requires the implementation of Electronic Lab Notebooks (ELNs) and Laboratory Information Management Systems (LIMS).

As the agencies are now trying to enforce the regulatory standards in a more stringent manner, data must comply with ALCOA principles laid out in the FDA and other agencies’ requirements. Whether recorded manually or electronically, it must be attributable, legible, contemporaneous, original, and accurate. These principles should influence all data throughout its lifecycle. Digital transformation will help make compliance an easier task for vendors and will ultimately lead to higher-quality products in the pharma market.

At a global level, we have been witnessing accelerated scientific innovation. Hence labs need to consider the technology investments required to become digitally enabled in order to keep up and stay competitive. We live in a data-driven compliance environment so scientific laboratories must fundamentally transform how they create, manage, and effectively use all the data that is generated in their lab ecosystem to fulfill the compliance requirements of regulatory agencies Achieving and sustaining a competitive edge in a world of constant change will require the continual transformation of lab operations and scientific data management. This will be the first and most important step toward becoming a truly digitized lab.

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