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What is an Electronic Batch Record?
What is an Electronic Batch Record?
Electronic Batch Records (EBR) help manufacturers track and document the entire production process via automated reporting software.
A smart Electronic Batch Record system automatically extracts real-time information from process equipment in digital format and securely stores it in the cloud.
Electronic Batch Records (EBRs) record data
Data recorded in EBRs include raw materials with traceability, quality control reports, workflows, process changes, maintenance guidelines, notes, drawings, and more. All digitized data is audit-ready, and can be easily searched and retrieved.
EBRs ensure compliance
In regulated industries, like pharma and biopharma, Batch Records are either mandatory or necessary to acquire precise manufacturing data for compliance and audit purposes – moving from paper-based Batch Records to Electronic Batch Records is revolutionizing efficiency, accuracy, and compliance with modern manufacturing practices.
EBRs streamline processes
But modern EBR platforms go beyond record keeping. They act as an essential tool that integrates with core production and supply chain systems, like an organization’s ERP and MES, and often act as a core component of an MES, enhancing efficiency and transparency – ultimately helping businesses make informed decisions and scale revenue.
Electronic Batch Records in Pharma/Biopharma
In Pharma and Biopharma, an electronic batch record is a paperless manufacturing solution articulated around the Pharma 4.0 initiative that fortifies regulatory compliance and auditability, as current regulations dictate.
What is Included in an Electronic Batch Record?
Just like manual batch records, EBRs narrate the end-to-end shop floor procedures. They provide a detailed audit trail of the manufacturing process, including:
- Raw material
- Equipment used
- Manufacturing Instructions, incl. notes and remarks
- Procedures followed
- Drawbacks, failures and repairs
- Process changes
- Quality records
- Inspection reports
- Reports of the outcome
- Deviations
- Electronic Signatures
Should staff or stakeholders need to see what’s happening in real-time, review historical data, or find any specific information, electronic batch records allow for quick and effective traceability and retrieval.
Why are Electronic Batch Records important in Pharma?
Electronic batch records in pharmaceutical production ensure that all production meets all the relevant regulatory compliance requirements including FDA, GMP, ISO. GAMP 5, ICH Q7, MHRA etc.) on the shop floor.
But Pharma manufacturers must also harness innovation and modernization to optimize processes, increase production uptime, and decrease waste.
In today’s rapidly advancing environment, digitizing life science manufacturing enhances operational efficiency at all production levels.
When properly implemented with an automated MES (Manufacturing Execution System) and ERP (Enterprise Resource Planning) software, EBRs help Pharma and Biotech companies enhance product quality and safety while boosting profitability and maintaining their competitive edge.
How Electronic Batch Records can improve Pharma Manufacturing?
Like any other industry, digital transformation in Biopharma and Pharma manufacturing leverages intelligent data, automation, and AI to achieve four main objectives:
- Optimize shop floor processes.
- Improve staff efficiency in a regulated environment.
- Elevate supply chain procedures.
- Enhance data visibility and transparency.
Pharma EBRs and data integrity
Though not yet mandatory, electronic batch records in Pharma are critical for manufacturers to adhere to current requirements on production records and data integrity, namely:
- Records should be assigned to specific users.
- Each record needs to be traceable through signatures.
- Stored data must be audit-ready.
- Archived recordings must be securely stored.
Undoubtedly, keeping track of thousands of log and batch entries without a paperless manufacturing solution is time-consuming and error-prone. An EBR software ensures flawless end-to-end documentation and data collection.
Pharma EBRs and workforce optimization
In the past, batches recorded on paper, generated countless pages that needed to be filled out and stored manually. This plagued the staff with endless hours of doing paperwork every week instead of focusing on value-added work.
A recent case study on a leading Pharma manufacturer revealed that – prior to digitizing, they needed 150 employees to review the site’s batch records and up to 6 employees to revise each document!
That’s why the company decided to integrate its DCS (Distributed Control System), controlling the factory equipment, with an EBR solution. The result? Seamless, real-time data extraction and substantial reduction in manual input.
And this is just one of many examples of how automated EBR solutions can benefit Pharma production operations.
Paper batch records slowing you down? See how Vimachem's EBR module can streamline production, reduce errors, and improve regulatory compliance.
Top benefits of Electronic Batch Records in Pharma
1. Data integrity & security
Advanced EBR systems hold digital records of equipment logs and every operation on the production floor. They also integrate with other systems and software for improved data quality and reporting.
Moreover, all data is stored and backed up offsite, with network and user account security.
2. Compliance & auditability
Electronic Batch Records ensure no data or workflow events are lost or skipped. They also easily adapt to changing regulatory requirements, which also saves businesses from needless warning letters.
Note that improper documentation made up 21% of the total CGMP warning letters a couple of years ago. More recent statistics report that approx. 8% of all FDA warning letters were mitigated with Digital Logbooks and Batch Records solutions.
3. Increased uptime
EBR software automatically verifies a batch with no errors or exceptions, so batches can be released quickly. This saves hours on manual review processes and increases uptime.
4. Improved quality
Electronic Batch Record systems contribute to higher quality in various ways. More precisely, cloud-based EBRs:
- Enhance data integrity
- Enhance compliance, traceability & audit-readiness
- Increase efficiency and reduce cycle time
- Reduce human errors
- Save time and review by exception
- Automate version control
- Distribute accurate information
- erform process error checks
- Promote right-first-time operation
- Allow staff to focus on valuable tasks
- Supports quality decisions
These crucial functions place Electronic Batch Records at the core of digital transformation initiatives for Pharma manufacturers.
Transitioning from Paper Batch Records to EBR in Pharma
Depending on your company’ s organization and needs, there are different ways to move from paper-based to paperless batch records.
Many businesses start by simplifying processes and removing unnecessary steps, such as the need for dual signatures.
Others apply EBR in a few major areas at first, before fully implementing across the business, while more roll out their EBR systems product-by-product, starting with those with the highest-volume of batch records.
No matter which digitization strategy you choose, you first need to purchase a powerful and flexible Electronic Batch Record software.
Best Electronic Batch Record Software for Pharma
Vimachem’s Electronic Batch Records solution is built exclusively for Pharma & Biopharma manufacturers.
Its out-of-the-box validation package and seamless integration capabilities speed up setup and implementation without operational disruptions or additional infrastructure costs.
Designed to meet changing regulatory compliance requirements in the Life Science industry, it can be easily adapted to new products and processes, scaling as your business expands to new sites and global operations. Ready to see a true return on your investment? – Request a demo today.
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