In this comprehensive overview, we delve into the advantages of EBR, address key concerns regarding its implementation, explore its potential to enhance quality and productivity, and offer guidance on initiating the digitalization journey in laboratories with powerful tool.
1. What are the advantages of EBR from BatchLine compared to other companies?
2. Do we need to place a computer inside the production room to record data?
I'm concerned about cleaning and cross contamination issue.
Workers usually use a tablet to record data. The tablet can be easily cleaned and will not leave the area helping to mitigate risk of cross contamination. The tablets can be cleaned by IP65 wipe down.
3.What is biggest challenge to implement electronic batch record?
Mindset shift: Moving from traditional paper-based record to an electronic system requires a change in mindset and work culture. Some employees may find change difficult or be uncomfortable with new technology. Overcoming this involves communicating how the EBR system will help them and the company, so they understand why the change is happening, addressing any concerns, and providing training and support to help employees adapt whilst closing any skills gaps.
Management buy-in: Convincing management about the benefits and value of EBR is crucial for success. Management may have concerns about the initial investment, business disruption, or resistance from employees. It is vital to present a clear business case highlighting the return on investment, improved operational efficiency, quality and regulatory advantages, and enabler of long-term continuous improvement.
Stakeholder alignment: Implementing an EBR requires collaboration and alignment across multiple departments and stakeholders. It touches production, quality assurance, IT, management, and regulatory compliance. Ensuring everyone is on the same page and understands the purpose and benefits of the EBR system creates a shared goal for the teams to focus on. Effective communication, regular meetings, and involving stakeholders early in the process builds consensus to facilitate a collaborative environment and smoother implementation.
4. How can electronic batch record improve quality & productivity?
Moving to an electronic batch record (EBR) offers significant benefits to efficiency and quality, as well as simplifying compliance tasks.
From a quality perspective, EBR improves data integrity, automates version controls and distribution of correct/effective information, performs process error checks, and encourages right-first-time operation. These improve overall quality simply by using the system, but also encourages a quality mindset by freeing staff to focus on important value-add tasks and quality decisions, rather than being tied up with basic admin involved with paper.
Efficiency improvements come significantly from Review-by-Exception, saving approx. 50% batch review/approval time, as the entire batch record no longer needs review. Other efficiency benefits accumulate from automation of workflows, data entry, signatures, date/time recording, and replacing manual checks with electronic controls. There is also no more paper handling, moving of paper (or waiting for records), costs of paper/printing, archiving/destruction etc.
5.What is the starting point to begin digitalisation in the laboratory, with many types/ brands of instruments and tools?
If you're unsure, it's always wise to start a plan by identifying your specific pain points and prioritising them (for e.g. in many labs sample management is a high priority pain point). From here you can define clear goals and objectives to look to solve through digitalization, knowing you plan will focus on areas with the most added value (usually beginning with areas which the most pain for the business).
Second, assess existing infrastructure, systems, and equipment, and understand its capabilities and connectivity options.
Next, research vendors that offer digital solutions in your areas of focus, considering compatibility with existing tools/instruments and potential for connectivity and data integration for key areas.
Look for the solutions that can solve groups of high priority business pains (if possible), consider the benefits of integration, and plan a phased project that leads to improved end state according to your plan. Start with quick proof-of-concepts only if there are unknowns to resolve, otherwise go to pilot projects that deliver real progress whilst also supporting the priorities and phasing of your overall plan.
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