Infionic: Integrating Pharmaceutical Business Processes Seamlessly

CIO Vendor The Indian pharmaceutical industry, which is among one of the top 5 exports from India, is growing exponentially and is predicted to hold the world’s third largest position in terms of volume. With ample scientific talent and technical entrepreneurs in India, this industry is set to outpace the average growth rate of Indian Industry. The industry however also faces tough challenges that are very real and significant. This sector is one of the most stringent manufacturing industries that play a key role in driving better health results with its affordable yet high quality medications. The development, manufacturing, testing and release of the drug products and substances is one of the most complex and heavily regulated amongst all other major exports from India. However, this industry is heavily fragmented. Connecting the information dots existing throughout the organization with the exchange and analysis of data can make a massive difference in drug research and innovation. And as these businesses continue to grow and become more complex, they need the support of technology to effectively manage copious amounts of accumulated data and help convert that into useful information to drive better business decisions and ensure regulatory compliance.

The compliance challenges of the industry have not been addressed yet by the information technology as the solutions are either expensive, several in number that are not integrated or just not available. Most solutions are currently available in Silos that do not talk to each other, making it difficult, expensive and impractical for several industries to exploit the advancements in Information Technology to their advantage. Every field, whether it is manufacturing, quality, dossier filing, research, project management, or even talent management, mandates the implementation of such technology.

Incepted in 2007, Infionic has been busy developing a solution for this complex industry. It has taken up the challenge to breaking down silos and integrating disparate systems to benefit this industry with quicker drug development, optimized research and lower operational costs. Infionic’s affordable technology platform will help pharmaceutical industries, both big and small, to use information technology to solve the regulatory and compliance challenges.

Unique modular structure
Its new-age enterprise software suite is as large as you want it to be. Its unique modular structure is easy to qualify as per CFR Part 11 and can be implemented however required. Its scope can be as small as maintaining tables like excel sheets with complete audit trails or as large as running your entire business operations.

"Infionic’s strength lies in building robust enterprise software that can integrate with multiple functions. Most enterprise software companies try to start small with one module and keep adding to it. We have done the opposite by building the full suite first and now we are carving out smaller modules out of it,” says Subramanyam.

Infionic’s products probably are what the Industry currently needs to battle the growing concerns around compliance and data integrity in general manufacturing and organization activities that are outside the well-regulated and developed chromatographic database systems such as Empower and Chromeleon. Infionic's products can be grouped into three major categories namely ONE, ZIP and MICRO.

“Most solution providers proffer solutions which cater to the needs of a selected function. This results in multiple silos. Infionic products seamlessly integrate cross functional teams and their needs thereby obviating the need of managing multiple applications in silos. Infionic provides solutions that can integrate diverse business processes without compromising on quality or regulatory requirements,” informs Subramanyam SP, Founder & CEO at Infionic.

INFIONIC ONE – An End-to-end solution
Infionic One is the flagship product of Infionic that is a comprehensive ERP which comes fully qualified and validated (as per CFR Part 11) out of the box. It seamlessly gathers, connects, and reports information across all functions within an organization. ONE has been designed and developed to function as an end-to-end solution that meets all the requirements within a pharmaceutical organization and integrates all departments and functions thus increasing companywide compliance.

Unlike other major ERP providers, the configuration of ONE is in the hands of the user and completely reduces the organizations reliance on mid-tier service providers. They either work directly with the developers or can configure the software the way it suits them with complete audit trail. The solution has been engineered on OFU Paradigm (Optimized, Flexible, Usable) for rapid implementation and adaptability to suit the specific needs of every organization as everyone has their own way to solve a common problem.

Effortlessly Managing the Entire Lifecycle of Man, Machine, and Material
The technology-driven platform comprises several modules that work at enhancing information accessibility and eliminate silos. Infionic's ONE has modules on its platform ranging from material management, procurement, asset management including maintenance and qualification, a comprehensive batch release program including a sleek and simple quality management system. The Software also has modules for manufacturing systems including production planning, eBMR and product costing, and finance & accounting.

Infionic also understands the commercial priorities of the organization and has extended their ONE software to meet organization's need on sales and its customers by embedding their one with a comprehensive CRM module that overlooks lead, inquiry & quote management, sale order management including dispatch schedules, business planning, goal setting and agent management. ONE also has modules for portfolio management, program and project management that caters to R&D, CapEx development and services delivery management. ONE also has a fully functional HRM component that ties up all users and modules together that includes, position management, recruitment, payroll, attendance, leave management, employee self-service and performance management.

Additionally, the platform is fitted with a Quality Management System as well that includes quality event management, training compliance, batch release, vendor qualification and electronic document management/ distribution. All in all, the innovative platform covers all aspects of business operations that can enhance faster and better decision making process.

ONE can simply help enterprises achieve better business outcomes with higher assurance. Driving ease of use and ensuring real-time availability, Infionic ONE is delivered both on web and mobile. With the ubiquity of mobile phones and BYOD trends, the Infionic ONE mobile app is designed to help users keep up to date with their tasks and approvals. In fact, Infionic is making sizeable investments in mobile platform as more users
are embracing mobile/ tablets which are rapidly replacing desktops. Furthermore, Infionic supports both on-premise and cloud deployment models.

INFIONIC ZIP - The compressed version of One
Infionic understands that it is not just cost of adoption that is a roadblock in companies adopting digital transformations to improve their business compliance. Infionic also understands that bandwidth and change management are equally large challenges in mid and smallscale industries trying to make it big. Hence, the development of the ZIP. It is a compressed version of its ONE software that includes only the essential tools of ERP that helps companies take care of their most basic operational challenges. ZIP is easy to implement and quick to adopt. It includes material management, finance and basic CRM that helps organizations begin the transformation with a small and easy step. It is extremely affordable and can be implemented with 'Zero' hardware cost to the company.

ZIP can be implemented with least effort within weeks in an organization and can be expanded to include any of the additional modules as needed. ZIP can evolve as per the growing needs of the organization.

Infionic’s strength lies in building robust enterprise software that can integrate with multiple functions

MICRO –The Functional Solutions
Infionic's promoter, Subramanyam has built a modular product that is easily customizable to each client's needs. The upside to this is that each product can completely run by itself in its own micro-environment. These slews of products belonging to their MICRO product portfolio include several customizable solutions to solve any specific need within an organisation. The more popular Micro products are the ones we tried to summarize here.

• Infionic COMPES – A dedicated product for contract manufacturing and contract research organizations focusing on costing and profitability while tracking all operations

• Infionic JOURNAL – An electronic Lab Notebook solution that improves efficiencies in R&D and helps in IP protection

• Infionic EVOLV – A comprehensive Quality Management System that covers quality events, training compliance, electronic document management/ distribution and vendor qualification.

• Infionic DOMINO – A portfolio, program and project management solution that helps improves visibility and efficiencies in an innovation management process.

Infionic's ZIP and MICRO products together dovetail an organization's growth plan and will be there at every step that the company takes towards higher compliance and technology adoption which are essential if they are to make a sustainable mark in the gigantic opportunity of Indian pharmaceutical exports.

An Overarching Portfolio of Solutions
Subramanyam goes on to tell us that the company is able to bring this comprehensive suite of solutions to its customers at a price that is extremely affordable and can very easily meet the budgets of the small and medium scale industries.

“Most enterprise software companies try to start small with one module and keep adding to it. We have done the opposite by building the full suite first and now we are carving out smaller modules out of it”

Driving Continual Innovation
Having established its market presence for over a decade, the company prides itself on its vast talent pool in technology implementation. Some of the team members even possess industry-rich experience before joining Infionic that helps bring real-life perspectives from the pharmaceutical domain into its product development and implementation lifecycles. Harnessing the power of next gen technologies and industry experience, Infionic has carved a niche for itself in this domain. The team has already geared itself up for the future, envisioning bringing an even bigger change in the pharmaceutical industry. The company has mapped out its plan for the next six to twelve months that includes launching of MICRO products which are function specific but to which other products can be added seamlessly to make it comprehensive. These include Quality Management System, Training Compliance, Production Planning, Procurement & Inventory Management, Contract Manufacturing Quote Management, facilities Management, Supplier Relationship Management & Professional services CRM and PPM.

Putting Customer Satisfaction On A Pedestal
With its office located in India and USA, Infionic has serviced a large client base over the span of more than a decade. Subramanyam, Founder and CEO of Infionic, goes on to recount two of the company’s most noted contributions in the pharmaceutical domain.

A contract manufacturing company for formulations with an approved FDA plant was struggling with multiple systems to manage quality processes. In addition to using multiple applications, the client still adhered to traditional approaches such as paper based processes to manage various aspects of quality. Transitioning from legacy systems and processes to fully integrated systems, the client requested implementing a system that can integrate all quality management processes to ensure no lapses in quality. Coming to the fore, Infionic implemented a combination of various modules to ensure all the processes are digitalized with little to no use of paper – Electronic Documents Creation and approval for all documents (SOP, SPECs, STPs, BMRs, BPR, MPCs, MFCs, Formats), Material Creation, Vendor Qualification, Quality Event Management (Deviations, OOSs, OOTs, Incidents, Market Complaints), CAPA and Change Control Management, Training Compliance, BOM Management, Product and SKU Master, Standards & Quality Management, Batch Release and Sample Management including generation of CoA. The result, post the implementation of the solution, observed by the client was higher data integrity, greater compliance, better control on quality processes, reduced paper usage and enhanced confidence to face an audit.

Another leading mid-size formulations manufacturer catering to regulated markets was looking at growing its business and client reach. However, impeding this progress was its usage of multiple systems to manage its operations. The company was looking to consolidate them into one system in an attempt to achieve operational excellence. Infionic ONE was implemented which covered all facets of the client’s operations right from material management, procurement & inventory management, manufacturing, quality assurance, quality control, asset maintenance, sales, finance, HR, Project to Program Management including CapEx projects. Subramanyam concludes, “A fully integrated system was implemented which is CFR Part 11 compliant.”