Pharma 21 CFR Part 11 - Pharmision Barcode India

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5 Incredible Benefits of 21 CFR Part 11 Compliant
Software
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If you maintain records or submit information to
the Food and Drug Administration (FDA)
electronically, you need to comply with 21 CFR
Part 11. If you are not aware of FDAs
regulation, this article will tell you all you
need to know about it, why its important for you
and the best way to implement it in your
organization. Well also tell you briefly about
how our 21 CFR Part 11 compliant solution stack
makes it super easy for you to not only adhere to
the FDA regulations but also benefit greatly from
it. What is 21 CFR Part 11? In August 1997, FDA
issued a set of regulations that enlist its
acceptance criteria for all forms of electronic
data. This set of regulations was issued as Part
11 of Title 21 of FDAs Code of Federal
Regulations, simply known as 21 CFR Part 11. It
applies to all electronic records that are
created, modified, maintained, archived,
retrieved, or transmitted. It also gives us
guidelines for setting up an FDA compliant,
digital Quality Management System, where digital
records and signatures are used in place of
traditional methods.
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The recommendations under 21 CFR Part 11 is in
line with Pharmaceutical Good Manufacturing
Practice (GMP). Why does 21 CFR Part 11
matter? 21 CFR Part 11 was introduced to
encourage widest possible use of electronic
technology and reap the benefits of increased
digitization. While increased innovation made
processes simpler, it also needed to establish
tamper-proof processes for authentication ad
control. Implementing 21 CFR Part 11 While the
guidelines are quite self-explanatory, they might
seem overwhelming for someone en route to going
digital. With our 21 CFR Part 11 compliant
solution stack, you dont need to pore over lines
upon lines of regulations. You can integrate them
into your existing system with little to no
effort and let our solutions handle the rest.
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Not only are our solutions compliant with FDA
regulations for electronic reports and signatures
but also add a ton of value when it comes to
digitization and upgrading your systems and
processes. Without further ado, lets dive into
what benefits our solution stack brings to
you 1. Maintain Audit Trail Part 11 requires
companies to maintain computer-generated,
time-stamped audit trails to ensure the
trustworthiness and reliability of
records. Recording the detail of every change
and sign off event by author, date and time gives
you complete traceability and accountability over
the decision-making process. Our solution eLOGS
captures all types of data at points of mandatory
requirements, transactions, and observations
electronically, while maintaining a digital audit
trail that allows quick access on
demand. Further, it also eliminates the chances
of incorrect entries with real-time alerts
enabling you to comply with 21 CFR Part 11.
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2. Ensure Data Integrity FDA requires you to
ensure accuracy, authenticity, integrity of your
electronic records. All our solutions enable you
to do that. For example, Manufacturing Operations
Traceability System not only ensures error-free
and guided execution of the entire production
process but also has an electronic batch
recording feature as per 21 CFR part 11. The
previously mentioned solution, eLOGS also allows
you to limit access to authorized individuals
only as per the regulations. 3. Validate Your
System 21 CFR part 11 requires you to validate
your systems and processes to ensure accuracy,
reliability, and consistent intended
performance. While all our solutions enable you
to validate your records, an example would be
Manufacturing Operations Traceability System,
which enables you to ensure complete adherence to
processes and assures complete sequence control,
helping you to validate your Quality Management
System (QMS), which is another Part 11
requirement. This ensures that your products are
not deviating from the desired quality standard.
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Protection of records to enable their accurate
and ready retrieval throughout the records
retention period. 4. Carry out System
Checks Part 11 requires you to carry out
operational system checks to enforce permitted
sequencing of steps and events, as
appropriate. Setting up automated workflows for
the collection of approvals and signatures give
you more control over people and processes in the
development cycle. An example for this would be
our solution PHARMISION WOMS, which takes a
unique data-driven approach to capture raw
material and inventory data at every event,
ensures sequence control in workflow and keeps
stakeholders informed of operating efficiency of
the entire warehouse in real-time. 5. Retrieve
Data Easily Part 11 requires you to enable their
accurate and ready retrieval of data throughout
the records retention period.
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Lets take our solution WMS (mobivue) for
instance. It allows you to not only drive
warehouse operations with maximum efficiency and
adhere to FEFO but also makes sure you have 100
traceability compliance, accurate data in
real-time, intelligent reports and critical
alerts. This means the records you need are
always available to you easily, allowing you to
access them easily whenever you need
them. Conclusion The right solutions can not
only make your adherence to 21 CFR part 11 easy
but also help you simplify and optimize your
processes and systems. Our solution stack is
easy to integrate with ERPs enabling two-way auto
data exchange, GMP compliant and collects and
stores data strictly following ALCOA principles.
Implementing our solutions will bring new levels
of efficiency to your entire development process,
reduce risks, costs, and time, and enable you to
completely digitize your existing systems with
little to no downtime.
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If you are interested in our 21 CFR part 11
compliant solutions, read more at https//www.phar
mision.barcodeindia.com/21cfr-part-11-compliance-w
arehouse-solutions. Feel free to reach out to us
and well be more than happy to clear any doubts
you may have. Visit our website
at https//www.pharmision.barcodeindia.com/