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PHARMACEUTICAL SOFTWARE

ABSTRACT

The whole pharmaceutical industry needed various innovative and scientific solutions to solve the current

problems related to pharmaceutical industries production, documentation, cGMP practices, and other regulatory

bodies. Now a day’s computer program are more suitable to monitoring and maintaining pharmaceutical records.

To fulfil the regulatory bodies requirements pharmaceutical software are been installed. There are roughly 19

types of software used in the whole Pharmaceutical Industry, the use of the software has marginally increased.

In this article, give the overview on different types of software and its importance and need is covered.

INTRODUCTION

The drug industry is one of the most regulated, and complicated industries to navigated timeline after a brand

new medicine takes decades to develop in-terms of time scale, cost capital. The pharmaceutical industry is

increasingly reliant on software to help manage data, streamline processes and maintain regulatory compliance.

Software has literally revolutionised every stage of the pharmaceutical value chain including drug discovery,

development as well clinical trials and even post-marketing surveillance. Which has led to a huge increase in

productivity and efficiency, with accuracy being much greater these days than ever before — allowing companies

to get their new innovative drugs approved by FDA cheaper and faster. This is why the case for software use in

one place, pharmaceuticals seems quite obvious and necessary given that drug development and

commercialization environment are so complex and highly regulated . Each type of software serves a specific

purpose, and companies may use a combination of different types of software to manage their operations.
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Throughout the past years software has grown more and more important for companies in the pharmaceutical

business as it stores data, harmonizes processes or satisfies FDA (The Food & Drug Administration)

requirements. Every domain in the pharmaceutical value chain be it drug discovery and development, clinical

trials or post-marketing surveillance has experienced a sea change with software applications. This has increased

productivity, efficiency and accuracy considerably bringing lucrative new pharmaceutical drugs to market

cheaper and more quickly. In this day and age, to succeed in the pharmaceutical industry is largely dependant on

how well companies have integrated software. This paper dives into the different sorts of software applications

frequently used in pharma, how they bring value and affect new drug development all through to

commercialization.

The use of software in the pharmaceutical industry is not limited to just one area but encompasses a wide range

of applications. Electronic Data Capture (EDC) is used for the collection, management, and analysis of clinical

trial data, enabling researchers to analyse data in real-time, identify trends, and make informed decisions. Clinical

Trial Management Systems (CTMS) are used to manage the administrative aspects of clinical trials, including

study protocols, budgeting, and recruitment. Pharmacovigilance Systems are used to monitor the safety and

efficacy of drugs after they are on the market, including adverse event reporting, signal detection, and risk

management. Electronic Document Management Systems (EDMS) are used to manage regulatory compliance,

including document creation, review, and approval. The use of software in the pharmaceutical industry has

numerous benefits. One of the primary benefits is improved efficiency, as software applications can automate

repetitive tasks and streamline processes. This can save time and reduce errors, allowing companies to bring new

drugs to market faster and more cost-effectively. Software also improves data management, allowing researchers

to collect, store, and analyse data in real-time, enabling faster and more accurate decision-making. Additionally,

software enhances compliance with regulatory requirements, which are essential for drug development and
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commercialization. I have used GPT-3.5, a language model developed by OpenAI with a knowledge cut off of

September 2021, to assist us in generating some of the texts for this review paper.

Fig 1: Types of Software in Pharmaceutical Industry

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Fig 2: Classification of Software in Pharmaceutical Industry

1 Electronic Data Capture (EDC):

It refers to software used in clinical research to collect and manage electronic data from clinical trials.

Its major goal is to replace traditional paper-based data collection methods, which are notorious for being

time-consuming and error-prone. EDC software is designed to collect data directly from clinical trial

participants and securely store it in an organised manner. This programme enables researchers to collect,

oversee, and monitor data in real time, thereby improving efficiency and speeding up clinical trial

outcomes. EDC software is essential for gathering, maintaining, and analysing clinical trial data. For

streamlined operations, it frequently combines with Clinical Trial Management Systems (CTMS) and

Clinical Data Management Systems (CDMS). Some of the EDC software are- Oracle Health
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Sciences Clinical, Medidata CTMS, BioClinica CTMS, BioClinica CTMS, Veeva Vault CTMS

(cloudbased software), Clinical Conductor CTMS.

2 Electronic Document Management Systems (EDMS):

EDMS (Electronic Document Management System) software is used to handle and maintain electronic

documents connected to medication development and production, such as standard operating procedures

(SOPs), regulatory submissions, and other relevant papers. Among the most common EDMS software

solutions used in the pharmaceutical business are- Veeva Vault, Documentum, OpenText, SharePoint,

MasterControl.

3 Pharmacovigilance Software:
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Pharmacovigilance software is used to track and monitor ADRs and other safety-related information.

Pharmacovigilance is a subset of clinical trials, classified as Phase IV or postmarketing surveillance. In

the field of medication safety, pharmacovigilance software is used to manage adverse events and report

potential safety issues with pharmaceutical goods. Pharmacovigilance software examples include:

Oracle Argus, ArisGlobal Safety, VigiFlow, AB Cube, PVWorks.

When selecting pharmacovigilance software, take into account factors like the magnitude and intricacy

of the pharmacovigilance system, the precise functionalities needed, and the financial plan.

4 Manufacturing Execution Systems (MES):

MES (Manufacturing Execution Systems) software is used during the manufacturing cycle for batch

processing, equipment supervision, and quality assurance. These are computer-based systems used in

manufacturing to monitor and control the production process. MES software often provides real-time

data collection, analysis, and administration of manufacturing activities, assisting manufacturers in

increasing efficiency, reducing inefficiencies, and increasing profitability. MES spftware are Siemens

Opcenter, SAP Manufacturing Execution, Wonderware MES, ABB Ability Manufacturing Operations

Management, Rockwell Automation Factory Talk Production Centre.

5 Enterprise Resource Planning (ERP) Systems:

Enterprise Resource Planning (ERP) software is used to manage corporate procedures and operations,

including duties such as inventory management, supply chain management, and financial operations.

Among the most often used ERP solutions in the pharmaceutical industry are: SAP, Oracle ERP,

Microsoft Dynamics, Infor ERP, Epicor ERP.

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6 Computer-Aided Design (CAD) Software:

Computer-Aided Design (CAD) software is used to create medication delivery systems such as inhalers,

injectors, and transdermal patches. CADD, or Computer-Aided Drug Design, is a method that uses

computer software to create and refine novel medicines or to improve current drug molecules. CADD

examines and simulates the interactions between pharmacological molecules and biological targets such

as proteins or enzymes using a variety of computer approaches. The goal of CADD is to identify potential

pharmacological choices with enhanced properties such as increased potency, selectivity, and

bioavailability while minimising adverse responses and toxicity. Some of examples of CADD software

are- Schrödinger, MOE (Molecular Operating Environment), Discovery Studio, Open Eye, Accelrys.
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7 Quality Management Systems (QMS):

Quality Management System (QMS) software is used to monitor and manage the quality of

pharmaceutical products throughout their full life cycle. This involves activities like document

supervision, dealing deviations and non-conformances, and managing change. Within the

pharmaceutical industry, there are numerous possibilities for Quality Management System (QMS)

software, some of which are as follows: Master Control, EtQ Reliance, SAP QM, AssurX, Pilgrim

Quality Solutions.

8 Regulatory Information Management (RIM):

Regulatory submissions to regulating organisations like the FDA are managed and filed with the help of

Regulatory Information Management (RIM) software. This includes tasks like product registration,

clinical trial application filing, and electronic regulatory document submission. Among the most

extensively used RIM systems in the pharmaceutical sector are: ArisGlobal RIMS, Veeva Vault, RIM,

ISI Regulatory Suite, Samarind RMS, Lorenz Docubridge.

9 Electronic Trial Master File (eTMF) software:

Electronic Trial Master File (eTMF) software is a form of software used in the pharmaceutical industry

to manage clinical trial documentation. The electronic study Master File (eTMF) is a digital adaption of

the traditional paper-based Trial Master File (TMF), which contains critical documents generated or

gathered during a clinical study. Among the most commonly used eTMF software solutions are:Master

Control, eTMF, SureClinical eTMF, Phlexglobal PhlexEviewe, TMF Connect.

10 Statistical Analysis Software:

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Statistical analysis software is used to assess and comprehend data collected from preclinical and clinical

research undertaken during trials. This software is critical in the pharmaceutical industry since it allows

for the analysis and interpretation of complex data gathered throughout the drug development process.

It enables researchers and statisticians to identify trends, patterns, and correlations in data, allowing for

informed decision-making based on the results. Among the most often used statistical analysis software

alternatives in the pharmaceutical business are: SAS (Statistical Analysis System), SPSS (Statistical

Package for the Social Sciences), STATA is statistical analysis software, MedCalc.

11 Simulation Software:

Simulation software is used in the pharmaceutical industry to reproduce and simulate the behaviours of

pharmaceutical products and manufacturing methods. This practise aids in the detection of prospective

problems and the refinement of the manufacturing process. Simulation software has numerous uses in

the pharmaceutical sector, including drug discovery, pharmacokinetic modelling, clinical trial design,and

process optimisation. Among the most commonly used simulation software alternatives in the

pharmaceutical industry are: GastroPlus, Simcyp, Arena, ADAPT (Advanced DoseResponse Analysis

Prediction Tool), Virtual Cell, MATLAB.

12 Sales and Marketing Software:

Customer Relationship Management (CRM), sales projection, and market analysis are just a few of the

sales and marketing responsibilities that sales and marketing software manages. Veeva CRM is a

customer relationship management, Salesforce Health Cloud, Marketo, Adobe Experience Manager,

SAP Sales Cloud, QlikView.

13 Data Analytics and Business Intelligence (BI) Software:

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Clinical trial data and sales figures are only two examples of large datasets that may be examined and

comprehended using data analytics and Business Intelligence (BI) software. This aids in the discovery

of trends and patterns, which aids in the direction of commercial strategy. Data analytics and BI software

are critical in the pharmaceutical industry for analysing large amounts of data and offering insights into

the efficiency of various business operations. Several common examples of data analytics and business

intelligence tools widely used in the pharmaceutical sector include: Tableau, SAP Business Objects,

SAS, IBM Congo’s Analytics, Microsoft Power BI, and Oracle Business Intelligence.

14 Electronic Health Records (HER) Software:

HER (Electronic Health Record) software is utilized to maintain comprehensive patient health records,

encompassing medical histories, test results, and medication histories. In the pharmaceutical industry,

HER software can also be employed to manage patient data associated with clinical trials, drug safety,

and pharmacovigilance. These platforms facilitate the digital storage and efficient management of

patient health data, contributing to improved patient care and pharmaceutical operations.Some examples

of HER software commonly used in the pharmaceutical industry include OpenClinica, Epic, Cerner,

Care Cloud, and Athena health.

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15 Manufacturing Process Management (MPM) Software:

Manufacturing Process Management (MPM) software is critical in the pharmaceutical sector for

controlling and organising various stages of manufacturing, from raw material acquisition to final

product distribution. The following are some examples of MPM software that is commonly used in the

pharmaceutical industry: SAP Manufacturing Execution, Camstar Medical Device Suite, Master Control

Manufacturing Excellence, Apriso Manufacturing Execution System, Werum PAS. (Joshi &

Salunkhe, 2020).

2. Benefits of Pharmaceutical Software

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Pharmaceutical software offers a wide range of benefits for both pharmacy professionals and patients.
These include:

1 Regulatory Compliance

Pharmaceutical software is often designed to comply with various regulatory standards, such as HIPAA
(Health Insurance Portability and Accountability Act) in the U.S., which ensures patient privacy.
Additionally, software tools may assist in complying with federal and state regulations for controlled
substances, including tracking and reporting prescription drug use.

2 Improved Medication Safety

With the help of clinical decision support systems, pharmacists can minimize the risk of medication
errors.

Features such as drug interaction alerts, allergy checks, and dosage guidance help pharmacists make safer
decisions when dispensing medication.

3 Increased Efficiency

Pharmacy management software streamlines many manual processes, such as prescription filling,
inventory tracking, and billing, freeing up valuable time for pharmacists to engage Patients and focus on
clinical duties. Automation of routine tasks also reduces the chances of human error.

4 Enhanced Patient Care

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By having access to comprehensive patient data through HER systems, pharmacists can collaborate more
effectively with other healthcare providers. This collaboration ensures that the patient receives the most
appropriate treatment based on their medical history, current conditions, and medication profile.

5 Cost Savings

Pharmacy software can reduce costs by minimizing medication errors, improving inventory management,
and speeding up billing processes. Proper stock management helps avoid unnecessary overstocking or
stockouts, both of which can result in financial losses.

3. The Future of Pharmaceutical Software

As a pharmacy student, you should be aware that pharmaceutical software is continuously evolving.
Advancements in artificial intelligence (AI), machine learning, and data analytics are

Shaping the future of pharmacy practice. These technologies have the potential to revolutionize drug
therapy management, enhance clinical decision-making, and further personalize patient care.

Key trends to watch include:

• AI-Driven Drug Discovery and Personalized Medicine: Al and machine learning

Algorithms are being used to analyse vast datasets to predict drug interactions, recommend personalized
therapies, and even discover new medications.
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• Telepharmacy: With the rise of telehealth, tele pharmacy software is becoming more prevalent,
enabling pharmacists to provide virtual consultations and medication therapy management services to
patients in remote areas.

• Blockchain for Medication Traceability: Blockchain technology is being explored to

Enhance medication traceability, helping to prevent counterfeit drugs from entering the supply chain.

6. Conclusion
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Pharmaceutical software is transforming the practice of pharmacy, enhancing both the safety

And efficiency of pharmacy operations. As a pharmacy student, embracing technology and understanding
how various software solutions work will be crucial to your future practice. Whether it’s improving
medication safety, enhancing patient care, or streamlining operations, the integration of pharmaceutical
software into the pharmacy environment will play an increasingly important role in shaping the future of
the profession.

By staying informed about the latest developments in pharmaceutical software, you will be better
equipped to provide the highest standard of care and make a meaningful impact on patient outcomes in
your future career as a pharmacist.

Declaration by Authors
Contribution: The entire review was conceptualized, designed and conducted by the author. The

Author read and approved the final manuscript.

Ethical Approval: Not Applicable

Acknowledgement: None

Source of Funding: None

Conflict of Interest: The author declares no conflict of interest.

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