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ELog Software - Pharmision Barcode India

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According to FDA’s 21 CFR Part 11, recording and maintaining equipment usage, cleaning, and other GMP activities with the necessary audit trails are essential. Yet, despite its significance, log documentation today is still primarily a time-consuming, paper-based process that puts life sciences manufacturers at serious compliance risk. For more information, visit – PowerPoint PPT presentation

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Title: ELog Software - Pharmision Barcode India


1
Why Must Pharmaceutical Companies Switch to eLog
Management Solutions? - Pharmision Barcode India
2
According to FDAs 21 CFR Part 11, recording and
maintaining equipment usage, cleaning, and other
GMP activities with the necessary audit trails
are essential. Yet, despite its significance, log
documentation today is still primarily a
time-consuming, paper-based process that puts
life sciences manufacturers at serious compliance
risk. Data entry by hand in paper logbooks is
labor-intensive and prone to error. First,
employees spend hundreds of hours creating,
reviewing, and approving logs. Then, during
audits and inspections, they waste more time
locating this information, which is often stored
in various physical locations. Drawbacks of
paper-based log management The pharma industry
has historically needed to be faster to adopt new
technology. As a result, many companies continue
to follow paper-based log management. However,
here are some challenges with this manual and
paper-based approach Reduced productivity Manua
lly recording log activities uses many resources.
Equipment usage logs take time to physically (and
methodically) record the date, time, product, and
lot number of each batch. It takes just as long
to register the necessary cleaning data. As a
result, productivity is severely impacted by
manual log management.
3
High likelihood of human error Mistakes are
unavoidable because of the enormous amount of
information you must log through manual data
entries. Your compliance risks significantly
increase regardless of whether you entered the
information incorrectly or if it is simply
illegible.   Increased risk of 483s Inaccurate
paper logbooks can result in deviations, Form 483
observations, warning letters, and even
regulatory fines and sanctions.   Data loss and
rework Paper logbooks can be lost or misplaced
due to human error or calamities like fires and
floods. Employees frequently spend hours
performing the same tasks. These delays slowly
down time to market, increase production and
overhead costs, and could be more
efficient.   Lack of visibility Physical
logbooks are often found dispersed throughout an
organization. Reviewing historical log
information requires sifting through mountains of
paper records kept in offsite document storage
facilities. When every second counts during an
audit or inspection, this can result in a
significant waste of time. Offsite storage is
expensive in addition to being inconvenient.
4
What does an eLog solution do? An eLog management
solution digitizes your area and equipment logs
so you can check or review them online. It
enables you to record information about a batch,
the participants, and the time of an activity
from a location or piece of equipment as it
occurs, archiving your logs electronically so
users can search and retrieve the logs at a
moments notice. Additionally, it assists in
data organization and can present the log entries
as actionable reports and analytics. With eLogs,
managing your audit is simple, and you can save
money on printing, storing, and keeping log
documents. By completely eradicating the need for
paper, you can store your data securely and
access it whenever you like, all while assisting
your organization in achieving its sustainability
goals.
5
How eLogs assist in real-time Pharmaceutical
companies that want to streamline operations and
boost their bottom line should consider using
electronic log solutions. Here are a few ways
that electronic log solutions can assist
pharmaceutical companies with real-time
analytics Real-time visibility into
operations Electronic log solutions give users
access to up-to-the-minute information on the
whereabouts and status of various
equipment.   Increased data accuracy and
dependability Electronic log solutions
automatically collect and store data,
guaranteeing the accuracy and reliability of the
information. Data analysis Electronic log
solutions can analyze the information gathered
around the user, areas, and equipment. This
analysis can assist in identifying trends,
patterns, and areas for improvement.  
6
Predictive analytics Electronic log solutions
can use predictive analytics algorithms to
forecast potential future problems before they
arise and adjust operations or send alerts as
necessary. Compliance with regulations Electroni
c log solutions can assist pharmaceutical
companies in adhering to laws, regulations, and
mandates. Doing so significantly decreases the
possibility of fines and penalties, and log
management operations comply with industry
standards. Conclusion Pharmaceutical companies
looking to enhance their operations and achieve
the highest log management standard should
consider using electronic log solutions.
Electronic log solutions can assist pharma
companies in optimizing their operations, cutting
costs, and increasing customer satisfaction by
providing accurate and reliable data, real-time
visibility, automatic data analysis, predictive
analytics, and regulatory compliance.
7
With years of experience in resolving business
issues, our team of subject matter experts
created the eLog Management Solution by
Pharmision. This configurable tool allows you to
create, store, retrieve and analyze your logs to
ensure a higher standard of compliance. It can
create, design, and store the log sheets (forms),
as per the approved SOPs, like equipment logs,
calibration logs, Cleaning/ maintenance logs,
production logs, and other usage logs. ELogs by
Pharmision only allows authorized users to create
and modify logbook templates quickly and can be
configured to the unique process requirements of
each site. It is a scalable, user-friendly
solution compatible with your existing
systems.   If you want to know more about eLog
Management Solution, please contact us here or
visit the solution page that outlines its key
features and benefits. 
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