PROJECT

PRACTICE SCHOOL
about

PHARMACEUTICAL
SOFTWARE

SUBMITTED TO: SUBMITTED BY:

MS.Rashmi Singh Ma’am DEEPIKA
(B.PHARM 4thYEAR)

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Pharmaceutical
Software
Abstract:
The pharmaceutical world, creating custom
software solutions has become crucial.
These programs help companies in the
industry work more efficiently by
simplifying tasks, assisting in finding new
medicines, and ensuring patients receive
better care. Pharmaceutical companies
increasingly turn to personalised software
solutions to improve their operations and
stay competitive in the ever-changing global
market.

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Throughout this article, we’ll dive into
software development in the pharmaceutical
industry. We’ll explore how these programs
solve problems, the challenges companies
encounter when putting them into action,
and the evolving role of software
development in this sector.

What is pharmaceutical
software development?
Software development in pharma refers to
creating software that meets the needs of the
pharmaceutical industry. These solutions are
tailored to help with managing clinical trials,
tracking drug manufacturing processes,
ensuring regulatory compliance, and
handling data related to drug discovery. The
goal is to improve efficiency, accuracy, and
overall effectiveness in developing and
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producing pharmaceuticals through
technology.

Business benefits of
pharmaceutical software
development
Software development for pharma brings
several key business benefits to the industry:
 Improved efficiency: Streamlining
processes such as drug development,
clinical trials, and regulatory compliance
leads to increased operational efficiency.
 Enhanced data management: Software
allows for the efficient collection,
organisation, and analysis of large
amounts of data.
 Regulatory compliance: This helps in
avoiding legal issues and maintaining a
good reputation.

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  Cost reduction: Through automation
and improved efficiency, companies can
reduce costs associated with manual
processes, paperwork, and potential
errors.
 Faster time-to-market: Streamlining
processes and improving collaboration
through pharma software development
can accelerate the time it takes to bring a
drug to market.
 Better collaboration: Pharmaceutical
software facilitates communication and
cooperation between teams and
departments. This helps in fostering
teamwork, especially when working on
complex projects.
 Patient safety: Enhanced tracking and
monitoring capabilities in software
contribute to improved patient safety.
 Adaptabilitity changes: In a dynamic
pharmaceutical industry, software
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 solutions can be adapted to changing
regulations, market demands, and
technological advancements, ensuring
that the business stays up-to-date.
 Data security: Robust software
solutions help maintain data security and
confidentiality, prevent unauthorised
access, and ensure compliance with
privacy regulations.
 Competitive advantage: Companies
that invest in custom software
development for pharma can gain a
competitive edge.

Key features of
pharmaceutical software
Pharmaceutical software typically
incorporates various features to address
the industry’s specific needs. Here are
seven key ones:

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  Regulatory compliance
management: Ensures adherence to
industry regulations and standards, such
as GMP (Good Manufacturing Practice)
and GCP (Good Clinical Practice). Helps
pharmaceutical companies avoid legal
issues and maintain compliance with
regulatory authorities.
 Data security and audit
trail: Implements robust security
measures to protect sensitive data.
Records and monitors all user activities
within the system. Safeguards patient
information and intellectual property and
ensures accountability for actions taken
within the software.
 Clinical trial management: Facilitates
the planning, tracking, and managing of
clinical trials, including patient
enrollment, data collection, and
regulatory reporting. Streamlines the
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 complex clinical trial process, ensuring
accuracy and efficiency.
 Integrated data management: Enables
efficient handling, analysis, and storage
of data generated throughout the drug
development lifecycle. Supports
informed decision-making by providing
a centralised and organised repository of
relevant information.
 Quality control and
assurance: Monitors and manages the
quality of pharmaceutical processes,
from manufacturing to distribution.
Tracks deviations and ensures adherence
to quality standards. Helps maintain
product quality compliance and reduces
the risk of defects or recalls.
 Supply chain management: Manages
the end-to-end supply chain, including
inventory, procurement, and distribution.
Ensures efficient and traceable
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 movement of pharmaceutical products.
Enhances visibility, reduces errors, and
ensures the timely availability of drugs in
the market.
 Electronic Batch Records
(EBR): Digitizes and automates the
documentation of manufacturing
processes, ensuring accurate and
compliant record-keeping. Improves
efficiency, reduces paperwork, and
facilitates real-time tracking of
manufacturing activities.
 Reporting and analytics: Provides tools
for generating reports and analytics,
offering insights into key performance
indicators, compliance metrics, and other
relevant data. Supports data-driven
decision-making, helping identify trends,
issues, and opportunities for
improvement.

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Regulations and standards to
consider in pharma software
development
Custom software development for pharma is
subject to various regulations and standards.
Here are some key regulations and standards
that developers need to consider:
Good Automated Manufacturing
Practice (GAMP)
GAMP provides guidelines for the
validation and compliance of automated
systems in pharmaceutical manufacturing.
Ensures that software used in manufacturing
processes meets quality and regulatory
requirements.

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Good Clinical Practice (GCP)
GCP is an international ethical and scientific
quality standard for designing, conducting,
recording, and reporting clinical trials
involving human subjects. Software used in
clinical trial management must adhere to
GCP guidelines to ensure the integrity and
reliability of trial data.
Good Laboratory Practice (GLP)
GLP ensures the quality and integrity of
non-clinical laboratory studies supporting
research or marketing applications. Software
used in laboratory settings must comply with
GLP to maintain data integrity and
traceability.

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21 CFR Part 11: Electronic Records;
Electronic Signatures (FDA)
Outlines the criteria for which electronic
records and signatures are considered
trustworthy, reliable, and equivalent to paper
records and handwritten signatures.
Applicable to software used in processes
that generate electronic records and require
electronic signatures in the U.S.
pharmaceutical industry.
ISO 13485: Medical devices – Quality
management systems
Establishes requirements for a quality
management system specific to the medical
device industry. Relevant for software
associated with medical devices used in the
pharmaceutical industry.

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ISO/IEC 62304: Medical device
software – Software life cycle
processes
Defines lifecycle processes for
pharmaceutical software developers and
software within medical devices. Applicable
to software associated with medical devices
used in the pharmaceutical industry.
ISO 14971: Medical devices –
Application of risk management
Provides a framework for managing the
risks associated with medical devices. It is
important for software involved in
developing or operating medical devices in
the pharmaceutical sector.

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HIPAA (Health Insurance Portability
and Accountability Act)
Protects the privacy and security of patient’s
medical information. Pertinent for software
that handles electronic protected health
information (ePHI) in healthcare settings
within the pharmaceutical industry.
EU General Data Protection Regulation
(GDPR)
Protects the privacy and security of personal
data of European Union citizens. This
applies to software that processes personal
data in the pharmaceutical industry, mainly
when dealing with clinical trial data.
Data Integrity Guidelines
Ensures data accuracy, reliability, and
consistency throughout its life cycle. It is
crucial for software handling and managing
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data, especially in the context of clinical
trials and manufacturing processes.

Types of pharmaceutical
software
There are several types of pharmaceutical
software includes

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