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The Future of Traceability: The
Impact of eQMS on Electronic
Batch Records
Traceability is a fundamental element in ensuring product quality, safety, and
compliance. Whether it's cannabis, pharmaceuticals, or food and beverages,
being able to track and document the entire production process is essential.
With advancements in modern technology, traditional paper-based systems are
gradually giving way to more sophisticated and efficient solutions. One
revolutionary development in this realm is the adoption of Electronic Batch
Records powered by electronic Quality Management Systems (eQMS).
What are Batch Records?
A batch record serves as the life history of a product batch, documenting all
processes and steps it undergoes to become the final product. It includes
essential information such as dates, growth stage transitions, location changes,
nutrient application, Integrated Pest Management (IPM) tasks, and all cultivation
and processing steps outlined in Standard Operating Procedures (SOPs).
It also must include any quality-related issues during the production process whether there was an unplanned deviation, an issue with input (raw) materials,
or even testing of the final product (i.e. an out-of-spec Certificate of Analysis or
‘COA’).
For a robust quality assurance program, it is crucial to ensure that batch records
are exceptionally detailed. However, creating such detailed batch records
demands significant time and effort from both Quality Assurance and
Operations teams, potentially causing delays in batch release and overall
production timelines.
QMS streamlines
these efforts
without
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quality or compliance. Plus, without linking your executed batch records to the Schedule a
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master batch record in your library,RESOURCES
there is also aPRICING
risk of not CONTACT
referencingUSthe
correct version.
The Evolution of Batch Records: From Paper to Electronic
For decades, industries have relied on paper-based batch records to document
the step-by-step processes involved in manufacturing products. While these
records served their purpose, they were not without limitations. Paper-based
systems were time-consuming, error-prone, and challenging to maintain,
especially in companies dealing with high production volumes.
The emergence of electronic systems began to transform these challenges into
opportunities. eQMS offers a centralized platform for document control,
training, deviations, and other quality processes - becoming a game-changer in
terms of traceability!
C15 Solutions consolidates key information such as sanitation records, quality
investigations, COA results, supplier corrective action requests (‘SCARs’) and
equipment calibration records. The platform’s Automated COA Analysis provides
an instant pass or fail result, accompanied by a visual trend analysis that
facilitates the batch-release process, ensuring conformity with target
specifications.
Ensure production readiness with visibility into your equipment status.
Learn how else C15 is empowering cannabis businesses.
How eQMS and Electronic Batch Records Revolutionize Manufacturing
Real-Time Data Capture
Immediate visibility into operations enables companies to identify and rectify
issues promptly. Decision-makers can access live data, enabling a faster
response to potential problems and ensuring product quality remains
uncompromised.
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C15 gives you real-time visibility into the bottlenecks across your operation.
Reduced Risk of Errors
Manual data entry often leads to errors. eQMS eliminates this risk by governing
the entire batch run with stage-gated workflows, thereby automating data
capture, minimizing human intervention, and maintaining data integrity.
Enhanced Compliance
In highly regulated industries, the U.S. Food and Drug Administration's (FDA)
Current Good Manufacturing Practices (cGMP) require proof of proper handling
for every step of the production process. Batch records and other types of
manufacturing documentation demonstrate this level of accountability.
eQMS allows companies to create standardized workflows and enforce
compliance across the organization, making audits smoother and less timeconsuming. Moreover, eQMS offers compliant e-signatures, a requirement for 21
CFR Part 11 compliance (ONLY eQMS offers this feature - ERP, S2S & MES
platforms do NOT offer compliant e-signatures).
Interconnected Systems
eQMS platforms integrate with other critical systems like environment
monitors/controls, Enterprise Resource Planning (ERP) platforms, and
Laboratory Information Management System (LIMS) platforms. This
interconnectedness ensures a seamless flow of information across the
organization, enabling better collaboration between departments.
Version Control and Audit Trails
Keeping track of changes to batch records is crucial for maintaining an accurate
historical record. eQMS offers robust version control and audit trail capabilities,
allowing users to view previous versions, track changes, and understand the
sequence of events during the manufacturing process.
Data Analytics and Continuous Improvement
When you have your batch-run process handled by your eQMS, the production
team gets visibility across the entire operation. Relevant SOPs are associated
with each production process and equipment calibration and status can be
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verified pre-run. Batch-runs can be linked to real-time quality investigations and
processed accordingly.
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Plus, by leveraging analytics, companies
can enhance
overallCONTACT
efficiency,US 
resulting in cost savings and higher-quality products! C15 has developed an
eQMS platform that enables companies to reduce their cost of quality by 3040% To give further context into how large those savings are, they typically
represent anywhere from 10-20% of overall operating expenses - based on
actual C15 customer ROI analyses.
Above & beyond automated pass/fail analysis, C15 allows you to trend COA
results.
Training Management & Competency
An eQMS platform can track employee training and competencies, ensuring that
personnel involved in the batch-run process are adequately trained and
qualified for their respective roles.
Mastering the Digital Shift
Companies that embrace electronic systems and leverage their benefits will
position themselves at the forefront of quality management but there are some
considerations that companies must address during implementation.
Initial Investment: Transitioning from a paper-based system to eQMS requires
an initial investment in technology, training, and integration. However, the longterm benefits outweigh the upfront costs.
Data Security: As data becomes digitized, ensuring its security and protection
against unauthorized access becomes paramount.
User Training and Adoption: Proper training and change management is crucial
to ensuring that employees embrace the new electronic systems. User buy-in
and adoption are essential for the success of any eQMS implementation.
Regulatory Compliance: While eQMS can enhance compliance, companies must
ensure that electronic systems meet regulatory standards such as 21 CFR Part
11.
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The future of traceability lies in theRESOURCES
seamless integration
and Electronic
Batch Records as you can eliminate paper from the line with industry-leading
technology.
Looking to maintain a sustainable, competitive edge? Book a demo today.
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