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.

Panel
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
Offerings:

– 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

Timeline:

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 

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