Brief on Root Cause Analysis with example for “5” Why technique

Root Cause Analysis

Root Cause Analysis (RCA) is a method that is used to address a problem or non-conformance in quality process to get to the “root cause” (actual cause of origin) of the non-conformity.

RCA helps to correct or eliminate the cause and prevent the problem from recurring (preventive action).

Root cause analyses aim at improving products or processes quality and must an in systematic ways to be effective.

Root Cause Analysis Methodology

Different Methods of doing Root Cause Analysis                

  1. Fish bone technique
  2. The “5” Why’s technique.
  3. Barrier Analysis
  4. Change Analysis
  5. Casual Factor tree analysis
  6. Failure mode and effects analysis
  7. Pareto analysis


  • To identify non-conformity and the causes, so that permanent solutions can be found.
  • To develop a logical approach of problem-solving, using data that already exists in QMS.
  • To identify current and future needs for organizational quality improvement.
  • To establish repeatable systematic step-by-step processes, in which one process can confirm the results of another with deep analysis.


  • Not having the ability to understand the problem and therefore not defining it correctly.
  • Not considering all possible failure modes.
  • Not able to identify all root causes.
  • No proper defined solution for the non-conformity.

The “5” Why technique causes mapping.

Non-conformity identified: Decrease in the viscosity of Vitamin D3 syrup.

The “5” why technique can be expanded to 15 why or 150 why the deeper you go the more thorough analyzing takes place and reveals better solutions.

Brief on GAMP 5 Categories, V Model and 21 CFR Part 11, EU Annex 11

What is GAMP 5?

  • Good Automated Manufacturing Practice, Founded in 1991. International Society for Pharmaceutical Engineering (ISPE) sets the guidelines for manufacturers and the current Version is GAMP 5.
  • GAMP describes a set of principles and procedures that help ensure that pharmaceutical Software (Like QMS software, LMS software, DMS software etc.) has required quality.
  • Computer system validation (CSV) following GAMP guidelines require users and suppliers to work together so that responsibilities regarding the validation process are understood.
  • For users: GAMP provides a documented assurance that a system is appropriate for the intended use before it goes “live.”
  • Suppliers can use GAMP to test for avoidable defects in the supplied system to ensure quality products are produced.

Why GAMP 5?

  • Facilitates the interpretation of regulatory requirements.
  • Establishes a common language and terminology.
  • Promotes a system life cycle approach based on good practice.
  • Clarifies roles and responsibilities.
  • Focus attention on those computerized systems with the most impact on patient safety, product quality, and data integrity
  • Avoid duplication of activities

GAMP 5 Categories

Amplelogic GAMP 5 Categories

Difference between Category 4 and Category 5 in GAMP 5

  • Configuration and customization of software are terms that are poorly defined in the validation world and frequently used interchangeably, especially in a vendor’s marketing literature.
  • It is important to understand the difference between these two terms as they mean entirely different things and consequently can have a dramatic impact on the amount of validation work that you could undertake.

Configuration: The modification of the function of a software product to meet the business process or user requirements using tools supplied by the supplier. These tools can include the input of user-defined text strings for drop-down menus, turning software functions on or off, graphical dragging and dropping of information elements, and creation of specific reports using the standard functionality of the package.

Customization: The writing of software modules, scripts, procedures, or applications to meet business requirements. This can be achieved using an external programming language (such as C++ or .NET or PL*SQL for database procedures), macro instructions, or an internal scripting language specific for a commercial application.

Depending on the user requirements the same implementation can be Category 4 or 5

Amplelogic GAMP 4,5 Categories

What is SDLC Model? and What model GAMP 5 Suggests?

The software development life cycle (SDLC) is a framework defining tasks performed at each step in the software development process.

  • SDLC is a structure followed by a development team within the software organization.
  • IIt consists of a detailed plan describing how to develop, maintain and replace specific software.
  • The life cycle defines a methodology to deliver the quality of software and the overall development process.

What is SDLC Model? and What model GAMP 5 Suggests? The software development life cycle (SDLC) is a framework defining tasks performed at each step in the software development process. •	SDLC is a structure followed by a development team within the software organization. •	IIt consists of a detailed plan describing how to develop, maintain and replace specific software. •	The life cycle defines a methodology to deliver the quality of software and the overall development process.

What is 21 CFR Part 11 and EU Annex 11?

  • 21 CFR (Code of Federal Regulations) Part 11 has defined by the US FDA regulations that set forth the criteria applies to electronic records and electronic signatures that persons create, modify, maintain, archive, retrieve, or transmit under any records or signature requirement set forth in the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or any FDA regulation
  • Annex 11 is part of the European GMP Guidelines and defines the terms of reference for computerized systems software used by organizations in the pharmaceutical industry.

Amplelogic computerized systems software


  1. Any relation between GAMP 5 or v Model with 21 CFR Part 11?
  • Both are the set of guidelines which are used to validate a computer-based software used in pharma manufacturing companies.
  • The guidelines are predefined, and software should comply with the guidelines.
  • GAMP talks about “the How” and the 21 CFR talks “the What” during the Validation of computer-based software for Pharma companies.
  • GAMP is a methodology and 21 CFR are a regulation.
  • 21 CFR Part 11 is US FDA and Annex 11 is EU guidelines.
  1. A Company is delivering software to the banking sector they never heard of part 11 but when the Pharma customer wants them to map Part 11 requirements will the solution comply with them?
  • Even if a company is delivering software to the banking sector, the solution will generally comply with part 11 requirements.
  • In banking software’s there may not be the reference of Part 11, but the requirements of Part 11 will be met by the banking software’s
  1. A software company is following SDLC models from the past 8 years. For the first time, they are delivering a Pharma software solution. When the customer team comes for an audit what software development methodologies they need to demonstrate to win the auditor.
  •  Whenever there is an audit of the customer need to explain the detailed procedure followed to develop software right from the beginning of User requirement gathering to the maintenance and support.
  • Even if the company does not know the standard guidelines, we can map the existing followed procedure with the guidelines and standards to comply with client requirements.
  • The company which comes to audit have a set of guidelines or criteria which the supplier should comply to pass the audit.
  • The pharma companies investigate whether the software follows GAMP, or Part 11 or EU annexure 11.
  • To win the auditor the company must have followed an SDLC Methodology with Proper Reviews and Tracking.
  1. A software company doesn’t want to follow the V model, still wanted to deliver Pharma software(Quality management software, Document Management System, ANDA and DMF tracker etc.). Will this be acceptable to Pharma Company?

Acceptable if Software Company follows standard SDLC models and follows the Standards for developing and managing the code.

Amplelogic V Model

For further queries, and suggestions reach out to or visit

AmpleLogic GMP Compliance Software For Quality Operations

AmpleLogic Pharma GMP Compliance software system have been pre-configured to specifically address the requirements with the standards of FDA, 21 CFR part 11, EU annexure 11 and other regulatory bodies.

Pharmaceutical Business Process – Ready to Use Modules

No-Code Application Development Platform Benefits

Before explaining No-Code application development platform benefits, let’s first understand the problems with traditional method of an application development. Traditional process includes enormous amount of coding, involves interrupted maintenance and has bugs that needs to be found and fixed.

A new update in any application (either for web or for mobile) means old code has to be adapted, more code means more places for bugs to hide which leads to extended checkouts or outcomes.  Every single original line of code must be debugged, code that has to be read, understood and supported. Code based application production process involves business analysts, technical experts, database administrator, UX/UI developers, many developers to code, testers and project manager and all that code they add to the system, while expanding its capability, also increases a whole basket of costs. This process takes more time from original requirements to a deployed application, through inadequate ability to collaborate, often results in an unsatisfactory final product. For making more code requires more developers, which is a never-ending process in application development life-cycle.

With traditional approach, the problem is that person is not able to really change a functionality or a feature easily, especially when the coding language is unknown. Every time coding means lots of time and more organizational costs. To avoid these things and to get satisfactory results no-code platform comes as a rescue to organizations to shorten time, cost and to increase productivity in application development.

A no code platform is a hassle-free application development process that uses a visual development environment to let users to create apps without any need of prior knowledge on coding to create apps, through its powerful tools such as drag-and-drop, adding application components to create a complete application.

Definition of No Code application development platform simply states that less people are required to build an application with no-code platform. The visual platform is successful in making different applications with different modules and guarantees the success because the developer and the client who needs the app can work and discuss together due to the common language and collaboration ability that no-code development platform provides. No code simply provides configurable application software. This process results in 70% fewer resources means applications can be delivered eight times faster than the traditional development. It’s not only about developing faster but about delivering the desired application of business, shortening time to value.

Not everyone wants to spend the kind of money and time it takes to implement new or re-code existing enterprise software each phase your business requires change, so here are the benefits of no code application development platform software:

  • Quick- Because platform is constructed visually using pre-built modules, it’s quicker to build apps which helps organizations to be swifter. Whole process along with automated testing grazes the time spent on app development which allows it to start working, rather than preparing to work.
  • Cost-Effective- Talented developers needs costs high for coding and recoding, but no-code platform provides a way to bypass that by taking away a lot of the overhead cost that comes with necessitating a skilled team of developers in lifecycle. Also, because apps can be build that much faster with less resources it becomes cheaper in the long run.
  • Increased Productivity– Supple organizations and cost-effective development means no-code appscan be built at a much faster pace because the developer team is not burdened by requirements from other departments which turns in increased productivity. Pre -built modules don’t offer long waiting list of application development and can be said as what inured months for a single application development and maintenance, can now be done in a matter of hours and days.
  • Configurable- A no-code drag and drop feature which simply configure the application like if a person needs to change something or any feature in an app after development then he/she can change on its own without help of developer and can implement the change in a matter of hours.

No code Platforms simply transforms application development process easier and with business demand for custom applications expanding, it’s clear that traditional development approaches simply can’t keep pace. According to Gartner, by 2020, at least 50 percent of all new business applications will be created with high-productivity toolsets.

CAPA (Corrective Action Preventive Action) Software

To manage the quality of any system or organization CAPA is required. Corrective Action and Preventive Action (CAPA) Software helps in addressing and improving the real-time problems of the Pharmaceutical, Biotechnology and Life Science industries, ensuring that each identified risk and problem addressed completely in compliance with 21 CFR PART 11, EU Annexure 11 and other regulatory and process standard requirements. As the name mentioned, a corrective action deals with a nonconformity that has occurred, and a preventive action addresses the potential for a nonconformity to occur.

Corrective Action Preventive Action (CAPA) is a procedure which inspects and solves glitches, recognizes causes, takes corrective action and prevents recurrence of the origin causes. The ultimate purpose of CAPA is to assure the problem can never be experienced again. The determination to use the corrective and preventive action is to collect information, analyze information, identify & investigate product and quality problems by initiating appropriate and effective corrective and/or preventive action to prevent their recurrence. Basically, CAPA Software works on two principles, first goal is Root Cause Analysis (RCA) which is to find the root cause, base event or error that lead the problem and to take action directed at the root cause or error, and second goal is of Preventive Action (PA) is to inform an organization and prevent the problem from returning in other facilities lines or products. Essential factors to deal with product and quality problems, preventing their recurrence, and preventing or minimizing device failures, are verification or confirming corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documentation of the mentioned activities. Implementation of CAPA Software is required to identify the root cause of failure which is a key principle of any effective Quality Management System. When an issue arises, it is often just a symptom of the real problem like a disease, symptoms can be treated but digging out why the symptom has ben raised is the true motive for implementing CAPA. Failure to implement an effective Corrective Action Preventive Action process is a defilement of FDA regulations defining Good Manufacturing Practice (GMP). The whole process can be done after initiating the CAPA followed by defining the problem then cause investigation along with finding a solution (Action Plan) after that verification/validation and the implementation closing the CAPA after final step which is effectiveness check. CAPA Software implementation results in reduction in quality issues, reduction in the severity of issues, more preventive actions over time, better designed products/processes, improved customer satisfaction and better business results.

AmpleLogic: Offering GMP QMS to Achieve Optimum ROI

Aging population, chronic and lifestyle diseases, emerging-market expansion, and treatment and technology advances are expected to spur life sciences sector growth in 2015. Furthermore, efforts by governments, health care providers, and health plans to reduce costs, improve outcomes, and demonstrate value is dramatically altering the health care demand and delivery landscape. The Pharma and the Life Science companies are now depending on IT solutions to effectively evaluate tomorrow’s challenge, which is to develop new medicines that can prevent or cure currently incurable diseases. However, depending heavily on IT vendors will not do much good in the long run as an increased spending on applications for data analysis and related technologies for efficiency and better automation will result in imposing a weighty yoke on the finance division of the company, while the in- house R&D and IT team lies dormant. Organizations should invest in well architecture, scalable rapid app development platforms and build internal IT Teams to automate the Business processes.

Headquartered in Hyderabad and having offices at USA & Singapore AmpleLogic stresses the importance on, Pharma and Life Science companies investing on managing their internal IT departments effectively with meager help from outside vendors. AmpleLogic offers ready to use apps in the Pharma Business Process area without coercing their clients in any way to adopt their solutions. The company offers, Quality Assurance, Quality Control, Packing, Production and Engineering, Sales and Marketing solutions in the Pharma domain. After a considerable amount of Research, Dedication and Investments, AmpleLogic has developed Enterprise Automation, an automated GMP (Good Manufacturing Practice) Quality Management System. “The Enterprise automation is specifically developed for Life Science Companies to manage the Quality standards within their organizations. The web based rapid Application Development platform delivers complete business process automation within a short interval of time thus contributing to ROI,” says, Venkanna Chowdary Manne, MD Ample Logic.

Recently, AmpleLogic helped one of India’s largest Pharma Company, who wanted to have an online and offline data storage for sales and marketing team, by developing a unique excel component that ensures efficient user experience. Realizing their client’s varied demands, despite sharing the same industry, AmpleLogic provides an array of customer specific solutions. The company helps its clients with BIMS (Batch Record Issuance Management), along with this; the company also succeeds in helping them with a smooth transition to eBMR. AmpleLogic proffers adaptable graphical interface builders so that their solutions ensure complete competency into the client’s SOP’s while being cost effective. Furthermore, AmpleLogic assures the safety and security when sharing the login credentials by implementing a biometric authentication. Additionally, the company helps their clients in automating their QMS area.

Established in 2010, AmpleLogic has been working with companies like Dr. Reddys, Hetero, Natco, Granules, Bharat Bio-Tech to name a few. Observing the rate at which AmpleLogic is treading the Pharma and Life Science domain, it is only prudent to say that the company will be successful in helping CIOs of the companies in this sector to fully harness IT to their advantage.

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AmpleLogic: Proffering Ample Benefits & Maximum Quality at Minimal Cost

As digitalization has become inevitable, to fulfil their unique automaton requirements, businesses are either developing their softwares the traditional way or opt for ready-to-use softwares, which are touted to be cheap, but succumbs hefty monies for modification. On the other hand, besides consuming a dismal amount of money, the trample of traditional software development method treads down numerous potentially genius ideas, due to the long chain of command (that involves multiple stakeholders akin to project manager and architect) between the business analyst and developers during the 2-6 months deployment time.Considering the amount of time and cost it would require to change a single idea, it is safe to say that the codes are set in stone once it leaves the hand of business analyst. AmpleLogic team can deliver custom solutions at 8 times faster than Traditional IT service delivery Companies.

“Easily integrated with biometric devices to address the password sharing problems, Ample Logic allows users to login into multiple application son premises with one set of credentials.”

This is where AmpleLogic enters the picture with its No-Code Application Development Platform, which is a powerful responsive application development platform that enables configuration of complex business applications very efficiently with little help from technical teams.Cutting down the deployment time to mere three days, this platform allows business analysts to easily manage the change as the idea evolves at a very less cost, not to mention the luxury of observing how the application looks while analysts are creating it. Moreover, the platform is capable of addressing 80 percent of an organization’s needs without writing a single line of code. AmpleLogic has created 25 applications and added 12 components to accommodate the validations and business logic.

Maximum Quality at Minimal Cost

“To provide the best IT Solutions to our customers, being a growing company we would like to standardize our delivery automations. Good amount of time and money was invested to build a world class No-Code development platform that helps in delivering the solutions eight times faster than traditional models with high quality,” expounds Venkanna Chowdary Manne, Managing Director, AmpleLogic. Noting that it fits perfectly with packaged solutions and runs on existing infrastructure, it doesn’t incurany customization cost. Moreover, AmpleLogic has priced its solutions competitively to ensure RoI within six months. With sheer focus on Pharma, IT Infrastructure & Excel Automations, AmpleLogic’s team has built multiple applications on the platform.

Excel has become an integral part of professional life, but there are still many unanswered questions when it is shared among big group with multiple owners. Being a Microsoft Partner company, AmpleLogic endows its clients with MS Excel that has an automated tool features such as a centralized database that can be accessed from Excel, Secure Data Access with Active Directory, in-built workflow, role-based access, and automated emails, audit trials – all this without the help of any additional software.

The company’s vast experience gained in specialized in MES (Manufacturing execution system) for semiconductor Assembly and Test, made AmpleLogic confident enough to design, develop and integrate ERP Systems to crucial areas of a building component. AmpleLogic has designed its MES system with Resource Planning specifically to integrate crucial areas of a Raw material to Production, to equipment booking management and inventory control. The solution covers software, installation, ongoing training, and professional support, thus helping streamline client’s business processes to maximize productivity and profitability by addressing the complex issues. “Our unique excel automations streamlines the multiple Excel movements and versions by keeping User Experience intact,” expounds Venkanna.

Demystifying the IT Infrastructure Puzzle

As computer networks are getting more and more complex, the use of native tools or power shell requires dedicated resources with a deeper knowledge in Active Directory (AD) Management and related technologies. Keeping this in mind, AmpleLogic has developed a comprehensive AD suite with twenty features in user management, seven in Group Policy, six in OU, eleven in distribution & security groups and seven features that can make changes to many computer objects simultaneously, thus minimizing the time and complexity in computer management. Easily integrated with biometric devices to address the password sharing problems, AmpleLogic allows users to login into multiple applications on premises with one set of credentials. SSO with biometric integrations enforces password policies.

The company’s ready-to-use IT Infrastructure Management solutions simplify IT management, improve productivity and allow administrators to proficiently manage the applications, systems, endpoints and devices. With real-time alerts and notifications, the company with its IT infrastructure audit service helps administrators to crush the challenge of collecting the configuration changes & object level changes in tracking who, what, when & where the changes were made. Furthermore, the self-service option at windows login reduces help-desk workload and ensures password security. This ISO 9001-2000 certified company’s IT Infrastructure Solutions deliver value and gets control on the IT Infrastructure. Also, AmpleLogic’s Print Tracking software helps the organizations to track the print activity in the entire organization.

Facilitating Good Manufacturing Practices

AmpleLogic’s Pharma QMS Software and CGMP Quality Management Solution brings forth an exceptional transparency across Quality Systems and resolve quality issues down their roots. The company provides adaptable graphical interface builders so that their solutions ensure complete competency into the client’s SOPs while being cost effective. AmpleLogic enables clients to achieve good manufacturing practices (GMPs) at production facilities with Batch Record Issuance Management System (BIMS), a 21 CFR Part 11 Compliant solution with a blend of Document Management and an Issuance Management. Facilitating the FDA Current Good Manufacturing Practice (CGMP) regulated companies to demonstrate the process transparency of every production step, AmpleLogic enables easy integration with quality systems like CAPA, Incident and Deviations to enrich the process performance and traceability across the manufacturing process.

AmpleLogic’s Market Complaints Record, Management and Tracking Software automates complaints handling through robust root cause analysis tools, 24×7 global web accessibility that helps intake the complaints & respond immediately, assessments and closure with any associated CAPA. This enables organizations to acquire and retain customers through positive customer experience. “Our client-focused IT solutions mark the right balance of Quality, Reliability, Delivery and Pricing,” remarks Venkanna.

Customer is King

AmpleLogic’s solutions backed with deep domain understandings are aimed towards realizing a high business value to customers and associate with measurable and sustainable benefits. The company continuously learns and excels to better its relationships with customers, by accomplishing milestones at given timelines without compromising on Quality and Efficiency, all the while being affordable and customer friendly. Believing in innovation rather than chasing number oriented growth has facilitated this 2010-established company to successfully engage strong business relationship with leading Pharma companies like Sun Pharma, Dr. Reddy’s, ACG, Hetero, Natco, Granules, Akums, Bharat Biotech, Medopharmand in a miniscule period of six years. AmpleLogic’s Infrastructure software is also being extensively used at Serco, Hinduja Global, ESSAR, Shopperstop, Eureka Forbes, Bank of Maharashtra and IT Companies like Virtusa-Polaris, Birla soft, CSS Corp. and Fiserv among others.

Young & Dynamic Team Striving for Excellence

AmpleLogic’s culture is driven by the consuming passion in creation of industry standard solutions that are effective, efficient and lead the market competition. The strength and confidence to bring pure passion and practical solutions is a core quality of its team that drives AmpleLogic in a direction to lead the competition. The pool of experts at AmpleLogic is drawn from diverse backgrounds with core understandings and unmatched skills; who in turn add value to products/solutions in addressing challenges. The company’s operating philosophy – quality services, reliable solutions, long-term partnerships and affordable price/value structure – serves as the foundation of the growth of AmpleLogic as well as its clients.The young and dynamic team of AmpleLogic strive for being reliable and customer centric organization, continuously exploring opportunities for the growth of its customers and its organization.

Key Management:

Venkanna Chowdary Manne, Managing Director

Venkanna is responsible for managing and driving AmpleLogic’s performance, formulating and executing long-term strategies to continue the focus in building Innovative Products, and leading the company’s business operations. He is committed to developing strong customer relationships, with a passion for building AmpleLogic’s delivery capabilities, and a disciplined focus on operations and execution.

Prior to establishing AmpleLogic, Venkanna worked with Nucleus software and Polaris. He worked in key consulting engagements in India, US, UK, South Korea and Japan.

Janardhan Kumar Manne, Managing Director

Having over 20 years of experience in IT, Janardhan heads the Architectural division at AmpleLogic. He drives the company to adopt the latest technologies and address the IT development inefficiencies with internal automations.

Offices: Hyderabad (Headquarter), Chicago & Singapore

– Pharma Automations: QMS Automation, Batch Record Issuance Management, QC Automations, Artwork Management, Calibration Schedules Tracking Software, Training Management and Electronic Batch Recording
– IT Infrastructure Automations:
– Infrastructure Management – Active Directory Management, Exchange Server Management, Single Sign On, Group Policy Management, Employee Profile Management, Help Desk, AD Self Service, Remote Desktop Monitoring, Print Tracking and Asset Management & Reconciliation
– Infrastructure Audit – Office 365 Audit, AD Audit, Printer Audit, Exchange Server Audit and SQL Server Audit
Custom Services:MES&Excel Automations


2010 – Started operations in Hyderabad with first service engagement in Semiconductor MES system
2012 – Got certified as an ISO 9001-2000 organization, laid foundation to build No-Code Application Development Platform
2014 – Installed its first IT infrastructure automation solution
Successfully automated several FDA, MHRA and WHO approved plants
2016 – Built over 16 modules in Pharma domain & 24 unique Net components, AmpleLogic has won the hearts of over 35 marquee customers and 0.25 million users

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Tweaking V Model to Accelerate GMP Automation’s & Address Data Integrity Issues

A long list of data integrity warnings received by pharma companies have made them train their focus on building and fortifying their tracking mechanisms to prevent things from going wrong. One of the solutions is digitization and building a data repository to make it easily available to analyse issues and predict challenges.

However, the current challenge is that the digital transformation is going slower than expected, resulting in engagement of quality resources for a longer time. Implementation of pre-validated software’s like LIMS, DMS, QMS, LMS are taking longer than 12 months and electronic batch manufacturing records (eBMR) are taking more than three years. Most implementations are going beyond the scheduled time due to rework and mid-way requirement changes. This impacts all the documents and hence requires repeated updations with the latest changes. These complications should be addressed with smooth and flexible methods. In general, OQ duration is 60 per cent of the total effort of a project. It is questionable whether such an effort is constructive for configurable software packages (GAMP category 4 & 5). Even after investing a good amount of money and resources, they are not able to realize the expected outcomes.

Key challenges

On the pharma industry front

  • Business user requirements are not documented properly
  • Unstable senior management.
  • Functional requirements are not detailed enough and do not have traceability to user requirements
  • Very expensive change request. (Cost of change)
  • Traceability matrix is not maintained or updated

On the supplier front

  • Rigid systems (Need to write code for every major change)
  • Lack of domain knowledge and unskilled programmers
  • Traditional software implementation methodologies

V Model: Verification and Validation model

V Model to accelerate GMP Automations

Most of the software implementations in the pharma industry will follow this model. The success of V Model is when requirements are well defined with no ambiguity and acceptance criteria well defined.

In the V Model there are long cycle times from user requirement specification to user acceptance test and requirements may change in the meantime. The modelling of user requirements without seeing a running piece of software is abstract and usually requirements for modification arise when the final user deals with the running software for the first time.

The traditional V model software implementation methodologies will not create an interest among the business teams as it takes longer to address a change. If any changes happen midway, then the test documents, along with requirement documents, have to be updated. The cost of major change/ requirement gaps realised in the OQ stage will turn out to be very expensive and delays the validation process.

From the past 10 years, regulatory inspections focus more on software and computer system validation. Deviations have been cited across all steps of computer validation from writing specification and risk assessment to IQ/OQ/PQ, revalidation, reporting and change control.

The traditional V Model: It must be revisited based on our real time experiences

One important aspect is the Configuration and Experimentation phase. The introduction of this phase in between the User Requirement Specification and Functional Requirement Specification of the V model will help the business users in understanding the pre-validated software and relating the software with his problem statement.

This approach helps in realising the requirements before the finalisation of functional requirement specifications. The business user’s clear on the software outcome.

Adding the Configuration and Experimentation phase in the implementation cycle will address regulatory audit observations related to revalidation, deviations and multiple release managements.

The Configuration and Experimentation approach cannot be achieved through traditional configurable softwares. The configurable Software must have visual modelling capabilities which are commonly known as No code/Low Code Development Platforms. These platforms support Visual Modelling (The user can see the making of application)

The organisations must ensure that software service provider agrees to offer configuration and experimentation as part of the V Model. If the pre-validated software or configured software follows this model, implementation times can be reduced by 70 per cent.

This way, gaps can be easily identified during the Configuration and Experimentation phase and as implementation time gets reduced and allows us to complete OQ in 25 per cent of the total project time.

No code/ Low code Platforms

These platforms allows business and IT to collaborate in real-time, using visual models to capture business requirements as well as quickly iterate and scale apps while ensuring nothing gets lost in translation. Platform allows users to quickly turn their ideas into building up applications and transforming their manual processes to digital within days.

No-code development platforms provide drag-and-drop tools that allow business process engineering (BPE) teams to develop software quickly without coding. The platforms provide drag-and-drop components to quickly assemble and design applications at reduced timelines and efforts. They also help increase the business productivity and efficiency at the work levels. Both developers and non-developers can use these tools to practice rapid application development with customised workflows and functionality.

Global enterprises are looking for No Code Platforms to build actionable digital strategies for every part of their business.

When prevalidated GMP softwares like QMS, DMS, LMS, eBMR and Batch Issuance softwares were built on using this No Code/ Low code Platforms then addressing the Requirement gaps or change will be faster and minimal time with less no of people involvement. Even change management becomes easy using No Code Platform. Processes can be changed every now and then, even for a small change in traditional approach will take months’ time, using No-code platform can happen in days’ time.

The platforms offer

  • Visual modeling of business logic and workflows, with the ability to extend with custom code
  • Visual definition of data models
  • Drag-and-drop implementation of modern user interfaces for multiple devices
  • Application change and life-cycle management

Way forward for pharma organisations

This is the time for pharma organisations to step towards selecting prevalidated softwares with visual modelling capabilities (No/ Low Code Platforms) that helps business users in appealing digital experiences with human readable application models by keeping the cost constant.

Way forward for IT organisations

Software suppliers must focus on increasing speed with visual modelling instead of focusing on the documentation during finalization of requirements. IT wings of pharma companies/ IT organisations should invest in No/ Low code development platforms, limiting the communication by keeping less resources and more productivity. The adoption of these platforms that are designed to empower application development professionals in IT to accelerate app delivery for more architecturally complex applications.


In  India’s Foremost Pharma & Biotech Magazine 

Express Pharma COVER STORY &Express Pharma MagazinDIGITAL ISSUE PHARMA