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Leucine Team
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36 mins

Contents

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What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

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Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur.

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  1. Item 1
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Unordered list

  • Item A
  • Item B
  • Item C

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Bold text

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Heading

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Heading

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Heading

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Heading

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Heading

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

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What is an eBMR or electronic Batch Manufacturing Record?

As the name suggests, the Electronic Batch Manufacturing Record (eBMR) is a digital, computerized version of the traditional Batch Manufacturing Record (BMR) designed to overcome the shortcomings of paper based systems such as lack of traceability, lack of control over operator actions, difficulty swiftly pulling out data from piles of documents, human error and more, and deliver a seamless audit experience. 

Why are Electronic Batch Manufacturing Records Important in Pharma?

Due to the high impact that the pharmaceutical manufacturing industry has on patient wellbeing, quality and compliance are paramount. This industry is highly regulated and must adhere to the highest standards of quality control, as evinced by Code 21 of the US Federal Regulations (among others). The eBMR is a crucial measure through which pharmaceutical manufacturers demonstrate their commitment to the health and safety of their consumers, in keeping with § 211.188 of the US Code of Federal Regulations.

Why Opt for eBMRs? 

In the age of pharma 4.0, most leading pharmaceutical companies are opting for eBMRs, to harness the power of AI and digitization for their manufacturing processes. Here are some key benefits of eBMRs: 

  • Real-time Production Schedule Optimization: eBMRs enable automated scheduling adjustments, responding swiftly to demand changes while ensuring compliance with production constraints.
  • Streamlined and Compliant Line Clearance: With eBMRs, execute batch work instructions seamlessly, incorporating in-process interlocks and interactive instructions for error-free operations.
  • Automated Data Capture and Logging: Reduce manual errors with eBMRs' ability to integrate with equipment sensors, capturing critical parameters and automating data logging.
  • Proactive Monitoring of Batch Parameters: eBMRs provide live data visualization and a proactive alerting system, empowering real-time decision-making and intervention when parameters deviate from expected ranges.
  • Continuous Verification of Manufacturing Processes: Utilize eBMRs for automated statistical analysis and alerts for process drift, ensuring adherence to quality standards throughout production.
  • Instant & Compliant Batch Release: eBMRs facilitate integrated data checks and exception handling, streamlining the batch release process while maintaining compliance with regulatory requirements.
  • Real-Time OEE and Downtime Tracking: Monitor equipment performance with automated OEE calculation, performance trend analysis, and downtime tracking features, enabling proactive maintenance and optimization.
  • Intelligent & Automated Root Cause Analysis: eBMRs offer one-click access to relevant data, collaborative investigation workflows, and built-in root cause analysis tools for efficient deviation resolution.
  • AI-Assisted Configuration and Regulatory Compliance Integration: Leverage eBMRs' AI capabilities for comprehensive process setup and integration of regulatory compliance checkpoints, ensuring adherence to industry regulations effortlessly.

How to Select the Best eBMR Software for my Needs?

Here are some steps to help you select the best eBMR software:

  • Define Your Requirements: Start by clearly defining your requirements and objectives for the eBMR software. Identify key functionalities and features that are essential for your manufacturing processes, such as electronic data capture, electronic signatures, version control, audit trail capabilities, integration with other systems, and reporting capabilities. Prioritize the problems you would like to solve through adopting such a software. 
  • Evaluate Regulatory Compliance and Features Provided: Ensure that the eBMR software complies with your requirements as well as the relevant regulations, including Good Manufacturing Practice (GMP) regulations, 21 CFR Part 11 requirements for electronic records and signatures (if applicable), and other industry standards and guidelines. Verify that the software vendor provides documentation and support for regulatory compliance. Also ensure that the provider has the latest AI capabilities, effective cleaning validation and other controls. 
  • Assess Usability and User Experience: Evaluate the usability and user experience of the eBMR software to ensure that it is intuitive, user-friendly, and accessible to operators, supervisors, and quality assurance personnel. Consider factors such as navigation, data entry workflows, customization options, and training requirements for users.
  • Consider Integration Capabilities: Assess the integration capabilities of the eBMR software with other manufacturing systems, such as Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) systems, Laboratory Information Management Systems (LIMS), and Quality Management Systems (QMS). Ensure that the software can seamlessly exchange data and integrate with existing IT infrastructure.
  • Evaluate Vendor Reputation and Support: Research the reputation and track record of the software vendor in the pharmaceutical industry. Consider factors such as vendor experience, customer references, industry certifications, and technical support services. Choose a vendor with a proven track record of delivering high-quality software solutions and responsive customer support.
  • Scalability and Flexibility: Consider the scalability and flexibility of the eBMR software to accommodate future growth and evolving business needs. Assess the software's ability to scale with increasing production volumes, accommodate new product lines, and adapt to changes in regulatory requirements or manufacturing processes.
  • Cost and ROI Analysis: Evaluate the total cost of ownership (TCO) of the eBMR software, including licensing fees, implementation costs, training expenses, and ongoing support and maintenance costs. Conduct a thorough cost-benefit analysis to determine the return on investment (ROI) and justify the investment in the software.
  • Request Demos and Trials: Request demonstrations and trials of the eBMR software from shortlisted vendors to evaluate its functionality, usability, and fit for your specific requirements. Involve key stakeholders, including operators, supervisors, quality assurance personnel, and IT professionals, in the evaluation process to gather feedback and insights.

What AI Capabilities should I look for in my eBMR software?

  • Predictive Analytics: eBMRs can leverage historical data to predict potential issues or deviations in the manufacturing process, enabling proactive intervention and optimization.
  • Anomaly Detection: AI-powered eBMRs can automatically detect anomalies or deviations from expected patterns in manufacturing processes, enabling timely corrective actions and maintaining product quality.
  • Adaptive Scheduling: AI algorithms in eBMRs can dynamically adjust production schedules based on real-time data, demand fluctuations, and resource availability, optimizing production efficiency and minimizing downtime.

Root Cause Analysis: AI capabilities enable eBMRs to perform advanced root cause analysis, identifying underlying factors contributing to deviations or quality issues in the manufacturing process, thereby facilitating effective problem-solving and continuous improvement.

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Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur.

Block quote

Ordered list

  1. Item 1
  2. Item 2
  3. Item 3

Unordered list

  • Item A
  • Item B
  • Item C

Text link

Bold text

Emphasis

Superscript

Subscript