Use your QMS to keep your company’s policies and procedures aligned with the launching and scaling of your products.

The digital age has changed the way we act, think and communicate. Yet, in so many cases the world of quality and compliance is still managed and indeed hampered by manual, paper-based systems. Quality management needs to move into the digital age.  By modernizing legacy processes with an Electronic Quality Management System (eQMS) organizations can meet today’s quality challenges.

Quality Management Systems (QMS): Enable manufacturers to electronically monitor, manage and document their quality processes to help ensure that products are manufactured within tolerance, comply with all applicable standards and do not contain defects.

Quality Management System (QMS) software: 

• Provides the procedures, processes, structure, and resources needed to streamline manufacturing and ERP operations while cost-effectively managing quality issues. 
• As part of a closed-loop quality process proactively monitoring events across any enterprise source, effectively integrated Quality Management Systems (QMS) can identify potential problems before quality issues occur. 
• Events may include supplier issues, manufacturing non conformances, complaints, services, and audits – both local and global.
• Provides the procedures, processes, structure, and resources needed to streamline manufacturing and ERP operations while cost-effectively managing quality issues. 
• As part of a closed-loop quality process proactively monitoring events across any enterprise source, effectively integrated Quality Management Systems (QMS) can identify potential problems before quality issues occur. 
• Events may include supplier issues, manufacturing non conformances, complaints, services, and audits – both local and global.

Benefits Of Quality Management Systems:

Implementing a quality management system affects every aspect of an organization’s performance.

Quality Management Systems (QMS) integrated with Manufacturing Execution Systems (MES) are strategic to a manufacturer’s business, providing complete visibility to manufacturing, field use and service information. 

This knowledge helps to improve future product design efforts and to optimize production methods, allowing quicker ramp up in manufacturing. 

As a result, manufacturers employing integrated Quality Management Systems (QMS) enjoy 

• Decreased time to market, 
• Real-time product risk evaluation, 
• Minimization of recalls and negative brand exposure, and 
• Lower per-product costs due to quality and process improvements as well as 
• Decreased waste.

Additional benefits:

• Dramatic reduction of internal and external quality incidents
• Consistently higher-quality product output
• Significant reduction in the cost of quality operations
• A shift from problem detection to problem prevention
• Streamlined compliance with corporate and industry regulations

These benefits offer additional advantages, including:

• Defining, improving, and controlling processes
• Reducing waste
• Facilitating and identifying training opportunities
• Engaging staff
• Setting organization-wide direction
• Communicating a readiness to produce consistent results

Quality Management Systems (QMS) Capabilities and Outcomes:

Capabilities offered by Quality Management Systems (QMS) include:

• Global visibility across distributed operations
• Enforcement of process to ensure compliance
• Event monitoring and early trend escalation
• Global risk management
• Automatic containment of suspect items
• Intelligent root-cause analysis
• Automated quality assurance
• Adaptable best practices
• Enterprise scalability 

How do different business functions benefit from using QMS?

While the importance of QMS has traditionally been as a quality, audit and risk tool, some of the biggest gains come in other areas, such as leadership, customer service, sales and marketing, procurement, and HR. This has led to many organizations dropping the word ‘quality’ from ‘QMS’ and rebranding it as the business management system.

Element  And Requirements Of A QMS:

Each element of a quality management system helps achieve the overall goals of meeting the customers’ and organization’s requirements. Quality management systems should address an organization’s unique needs; however, the elements all systems have in common include:

• The organization’s quality policy and quality objectives
• Quality manual
• Procedures, instructions, and records
• Data management
• Internal processes
• Customer satisfaction from product quality
• Improvement opportunities
• Quality analysis

Establishing And Implementing A QMS:

Before establishing a quality management system, your organization must identify and manage various connected, multi-functional processes to help ensure customer satisfaction. The QMS design should be influenced by the organization’s varying objectives, needs, and products and services provided. This structure is based largely on the plan-do-check-act (PDCA) cycle and allows for continuous improvement to both the product and the QMS. The basic steps to implementing a quality management system are as follows:

• Design
• Build
• Deploy
• Control
• Measure
• Review
• Improve

Meeting the customer’s requirements, which helps to instill confidence in the organization, in turn leading to more customers, more sales, and more repeat business

Meeting the organization’s requirements, which ensures compliance with regulations and provision of products and services in the most cost- and resource-efficient manner, creating room for expansion, growth, and profit

The purpose of QMS is to ensure that, every time a process is performed, the same information, methods, skills and controls are used and applied in a consistent manner.

A QMS organizes this information to give each person access to their own custom to-do list. Permissions control who sees what and when. Overall, a QMS delivers a complete record of business processes, so you can better understand improvement initiatives.

Atachi QMS has an in built intelligence to capture documents processes, procedures, and responsibilities for achieving quality policies with strict adherence to GMP (Good Manufacturing Practices) and objectives of an organization.To learn more about Atachi QMS click here.

Continuous Change Requires Continuous Innovation:

Today’s pharmaceutical manufacturers and distributors are witnessing a paradigm shift in consumer behavior, market dynamics, margins, and increased compliance mandates brought about by the influx of modern technology.

• Efficient business processes,
• Centralized management,
• Quick decision-making, and
• Clear analytics

have become essential for any business to grow in the modern-day scenario.

What is pharmaceutical manufacturing technology?

The Pharmaceutical Manufacturing Technology (PMT) program is a specialized chemical technology program designed to meet the needs of the pharmaceutical and related industries (cosmetics, food, plastics, custom chemicals, research centers, pilot plants, etc.)

What do pharmaceutical manufacturers do?

Pharmaceutical manufacturers manage the distribution of drug products from the point of production to the drug wholesalers and in some instances, directly to retail pharmacy chains, specialty pharmacies, hospital chains as well as some health plans.

Manufacturers in the Pharma industry are challenged with a variety of regulatory compliance and government-mandated requirements that add cost and risk to their business. They must maintain strict quality management and detailed product documentation to meet customer specifications and regulatory requirements.

What Is Pharmaceutical Software?

Pharmaceutical manufacturing software refers to an umbrella term for a variety of technology solutions used by manufacturers, raw material suppliers, and wholesalers, including drug stores and healthcare provider

Tight healthcare budgets and long product development Lifecycle makes it difficult for a pharmaceutical business to maintain a competitive edge. It is designed to handle all of the pharmaceutical industry’s unique manufacturing, distribution, and accounting needs.

What is ERP in pharma?

An ERP software for pharma manufacturing industry not only enables the consolidation and integration of pharmaceutical manufacturing processes across multiple units but also helps businesses to keep a track of sensitive operations across the organization, such as compliance, expiry management, quality, formulation, and costing, etc.

Modern ERP with embedded AI, automation, and an immersive user experience is enabling continuous innovation across the business.

Benefits of ERP Software in Pharmaceutical Manufacturing:

Pharmaceutical ERP software offers the following benefits:

• ERP systems for pharmaceutical manufacturing ensure absolute compliance with the stringent regulations
• Eliminate risk by delivering safer products of superior quality at the right price and right time
• Introduce new products to market faster and cheaper than competitors
• Real-time batch monitoring to make perfect business decisions
• ERP software for the Pharmaceutical Industry helps in maintaining formula secrecy
• Respond quickly to customer demands
• Smoothen operational process flow and enhance profits
• Enhance the quality, consistency, and speed to deliver drugs to market
• Control costs through reduced wastage, optimum material utilization, and inventory management
• Pharma ERP software offer end-to-end bi-directional traceability, from the raw material to the finished product

The selection criteria for an ERP system:

“Which ERP software will meet our business requirements?”

• Your current software doesn’t meet your business needs
• Your competitors are getting ahead of you
• You’re wasting time manually tracking and monitoring inventory manually
• Your employees don’t like the software and complain regularly
• You spend a lot to keep the software updated
• You have disorganized data, and it’s hard to get the information needed quickly

Always remember your business goals while selecting ERP software. Here are some elements to keep in mind while going through the ERP selection process.

• Business requirements
• Management support
• User support
• Budget and resources
• Technology and future scalability
• Necessary customization
• Integration with existing systems

While selecting and evaluating ERP solutions, manufacturers should talk about the

• Industry-specific functionality offered,
• Future readiness of the software,
• If the software integrates with and supports digital capabilities, and
• What are your expectations for vendors?

A strong and experienced ERP partner can help you maximize your Return on Investment (ROI).

The implementation team takes the time to understand your specific requirements and recommends the right tool or solution that will complement your business needs.

When you evaluate multiple ERP options,

• Ask about functionalities,
• Ease of use,
• If the software is compatible with developing technologies,
• What the total cost of ownership is? and
• What training is available for users?

Here are some key questions to ask ERP providers in the selection process.

• What modules do they provide?
• Do they support advanced technologies?
• Do they offer a manufacturing-specific solution?
• Is their solution customizable and can it integrate with other tools?
• Are there limitations on the number of users?
• What kinds of software support do they offer?
• What is their industry experience?

Clearly defining your selection criteria for an ERP system while embarking on your research can help ensure good communications with vendors about their software. Make sure you understand all aspects of each solution to avoid regrets later.

ERP for Pharmaceutical Distributors:

A pharmaceutical distributor, while still operating under state legislation, will not be as closely regulated as manufacturers and as there are plenty of solutions that will let you create a manufacturing record and trace product genealogy you will have a bit more room to choose the best solution for you. This means that we can now look at more agile and cloud-based ERP products, such as Dynamic365.

As the markets continue to shrink, ERP software for pharma manufacturing industry has become an essential component of business management. Faced with global competition, pharma companies need to re-engineer their processes frequently to match up and maintain their quality. Adapting a comprehensive ERP software for pharma is a key step towards scaling and growing businesses in this segment.

Stay ahead of problems and take advantage of trends through machine learning prediction, intelligent automation, and other technologies.

ERP knows the ‘why’ of things, MES knows the ‘how to’.

While MES Sofware solutions primarily support business decisions, the ERP supports the operational ones.

Features of MES software solution:

• Collect process and machine data from data silos
• Automatically create notifications and logs for issues
• Enforce product specifications and business rules
• Defect tracking and automated corrective actions
• Perform real-time quality checks and yield monitoring
• WIP tracking and genealogy management (order, lot, product)

Features of ERP systems:

• Integration – A central view of essential financial, operational and business data that can be shared across the organization in near-real-time.
• Automation – ERP provides the ability to automate repeatable business tasks, such as payroll, order processing, invoicing, reporting and more.
• Data Analysis – Enabling employees to gather a wide variety of information and spin it into actionable insights
• Reporting – Compile information about business operations into reports that empower stakeholders to make more informed decisions, enhance business processes and identify problem areas before the business suffers.
• Tracking and Visibility – Allow companies to track, surface and understand business metrics
• Accounting- Ability to track, store and analyze financial data, such as accounts payable (AP), accounts receivable (AR), general ledger (GL), budgets and forecasting.
• Financial Management – Assist finance teams with the management process by tracking, analyzing and reporting critical business data.
• CRM- Bring customer relationship data into the mix, expanding the view of the business
• Sales and Marketing – Benefit marketing and sales teams by making it easier for them to sell, upsell, generate quotes and purchase orders, forecast, manage commissions and track key details like profit margins and ratios
• Human Resources – Acts as an end-to-end employee management platform, handling payroll, hiring, onboarding, compensation management and timekeeping.
• Supply Chain Management – Offer insight into a company’s supply chain management (SCM) efficiency by tracking demand, inventory, manufacturing processes, logistics and distribution.
• Manufacturing – Create efficiency in manufacturing processes by assisting with product planning, sourcing raw materials, production monitoring and forecasting.

What are the main goals of MES software?

• Improve quality while driving down production costs
• Improve the efficiency and throughput of production
• Enable a paperless workflow and eradicate errors
• Meet complex regulatory and client requirements
• Reduce lead times and improve delivery reliability
• Enhance inventory velocity and flow of materials

What are the main goals of ERP software?

• Improve customer service and data management
• Enhance inventory & supplier management
• Support advanced real-time planning
• Streamline communication & collaboration
• Enable more informed management decisions
• Synchronize reporting across departments

Who uses MES software?

An MES platform is mainly used by people who are involved in production, going from plant managers to process engineers and operators.

ERP software is used on a daily basis by:

• The sales department to enter and track production orders
• Supply chain managers to schedule production orders
• Inventory & procurement to order new raw materials on time
• The HR department for payroll management and administration
• Finance teams & CEOs for business analysis and forecasting
• The marketing team for pre-sales activities and sales follow-up

Difference between ERP & MES software:

ERP software focuses on integrating business processes and synchronizing reporting across departments. Data is displayed over a period of time, often with a certain latency. ERP is mostly used by people in business outfits and requires some training in order to make it your own.

MES software lands on the other side of the moon. It is used on the factory floor and focuses on optimizing the manufacturing process itself. MES provides visibility, information and detailed metrics of manufacturing operations in real-time, simplifying the workflow of machine operators. Take a look at following difference between MES and ERP.

ERP	MES
Business intelligence & reporting	Track & trace products & batches
Order processing & fulfillment	Guide the workflow of operators
Inventory management	Real-time production monitoring
Customer relation management	Automated waste registration
Supply chain management	Analyze production bottlenecks
Customer management	Finding reasons for downtime
Human resources management	Product quality optimisation
Marketing & sales	Schedule specific products

Wrapping It All Up : MES VS ERP

So the difference between an ERP and an MES and what they do best is:

ERP is the financial information system for the company.

MES is focused on the building of the Products that the company produces.

MES & ERP: A Match Made in Heaven:

ERP and MES solutions have a lot of crossovers between them in how they track the production process. However, manufacturing companies in Industry 4.0 need a blend of the two systems to make the plant run at its maximum performance and present accurate information for decision-makers.When ERP and MES systems are integrated, data from management functions such as customer service, order processing, finance and purchasing are integrated with data from manufacturing, such as production scheduling, machine throughput, WIP, inventory changes, shipped orders, and quality management. This results in gate to gate traceability and transparency to real time changes that current disparate processes could not capture.

Want to Make Decisions, Complete Projects, and work with Maximum Efficiency? – The Right ECM System will help you.

It is a systematic approach to managing content throughout its lifecycle. It enables unstructured information — such as Word documents, PDFs, emails, and scanned images — to be securely stored and made accessible to authorized users. By eliminating dependence on paper documents and organizing unstructured information according to business needs, organizations can simplify and streamline work.

How is ECM defined? 

It is a set of defined processes, strategies, and tools that allows a business to effectively obtain, organize, store and deliver critical information to its employees, business stakeholders, and customers.

Enterprise Content Management Software: 

Enterprise content management software provides corporations and organizations with a central repository to store, manage, archive, and otherwise handle data of varying degrees of confidentiality and importance.              

Key Benefits of (ECM) Software.

• Connect, access, visualize, maintain, manage, and eliminate siloed content repositories with a single overarching architecture.
• Increase employee productivity and reduce file redundancy.
• Automate business processes, making them structured, documented, and auditable. 
• Ensure government compliance through strict maintenance of file security, permissions, approvals, and lifecycle. 
• Integrate with other types of content management software to provide all-encompassing enterprise content management services. 
• Simplify workflow and Centralize collateral in one repository.

Who Uses (ECM) Software?

The benefits of enterprise content management software are not limited to one specific company size or sector.The solutions offered can be helpful to any company that requires better organizational tactics, whether that is in regards to their HR department, finances, account management, sales and marketing, administration, planning, governance, or another area.

Enterprise Document Management System– Document management, often referred to as Document Management Systems (DMS), is the use of a computer system and software to store, manage and track electronic documents and electronic images of paper-based information captured through the use of a document scanner. A document management system is used to automatically organize, secure, digitize and classify company documents, making them easy to access, edit and share.

Document management system software:Now, we can define document management as the software that controls and organizes documents throughout an organization. It incorporates document and content capture, workflow, document repositories, COLD/ERM, and output systems, and information retrieval systems.  Also, the processes used to track, store, and control documents.

What Key Features Should a Document Management System Have?

A document management system should have the following features:

• Powerful Workflows
• Data Integration
• Report Management
• Advanced Security Features

What are the Benefits of a Document Management System?

Document management systems should improve the way things run at your organization. They should give you:

• More Time to Do the Work That Matters 
• Convenience for an Increasingly Mobile Workforce 
• Peace of Mind. 

Your business is growing and so are your documents. Shouldn’t you be growing along with it? A document management system can take the burden of mundane tasks off your plate. That means more meaningful work—and more opportunities to grow your career alongside your organization.

What Is MES Software? Some Important Benefits and Details

The Hidden Factory – Not To Be Ignored:

The Hidden Factory refers to parts of a manufacturing process that decrease the quality or efficiency of operation -the mistakes, the rework, the waste – all the things that are kept hidden from the eyes of the customer. It is called the “hidden factory,” and it causes unseen profit leaks to companies every day of every year. 

• These wasteful processes and work go unreported and undocumented and are dangerous to a company’s bottom line.
• These factories are fueled by a dangerous attitude that the headaches and heartache caused by this Hidden Factory are surely worth it if the customer remains unaware and is ultimately happy with the product.
• All too often these daily drains on resources are going unnoticed or are even accepted as part of the process itself.           

Of course, you care about lost time, money, and effort, but how are you supposed to correct something you can’t see?

MES- How It Exposes The Hidden Factory:

A modern Manufacturing Execution System (MES) captures data that can be analyzed to uncover flawed processes, providing insights that expose the hidden factory.

How?

• A flexible MES documents, tracks, and reports the time it takes to deal with events  When studied with a trained eye, these reports reveal what went right and what went wrong. 
•  Manufacturing Execution Systems (MES) deliver a number of long and short-term manufacturing benefits, as well as strategic benefits such as improved yields, lowering operating costs, and increased compliance.

What is MES?

According to MESA (Manufacturing Execution System Association International),

• Manufacturing execution systems deliver information that enables the optimization of production activities from order launch to finished goods. 
• Using current and accurate data, MES guides, initiates, responds to, and reports on plant activities as they occur. 
• The resulting rapid response to changing conditions, coupled with a focus on reducing non-value-added activities, drives effective plant operations and processes. 
• MES provides mission-critical information about production activities across the enterprise and supply chain via bidirectional communications.”
• Manufacturing Execution Systems collect multiple plants’ production information and integrate easily with equipment, controllers, and enterprise business applications. 
• Although MES solutions are used to operate as a self-contained system, they are increasingly being integrated with enterprise resource planning (ERP) software. 
• The result is complete visibility, control, and manufacturing optimization – from the order placing, production inception, and process control to product output.

Why Do Companies Need A Manufacturing Execution System?

• Many companies still enter data manually or share work instructions on paper. Most of them, however, know there is a better way to organize the mass of activity happening on the plant floor.
• MES provides visibility to that activity as well as the underlying data, uses that data to improve how that activity is done and makes it repeatable. 
• It connects multiple sites, integrates with equipment, and raises the effectiveness of business applications all to better optimize operations.
• MES technology is helping manufacturers to reduce cycle times and achieve cost savings (production does not continue when critical issues are encountered), whereas the opportunity to improve planning activities is also resulting in improved utilization of equipment. 
• These systems also automate many manual documentation tasks, thereby eliminating related deviations and achieving better compliance. They are also removing calculation and review tasks that ordinarily would require considerable manual effort.

How does the move towards web-based MES solutions making it easier to support production operations and real-time activities: 

• HTML5 support now enables organizations to access MES across a range of digital devices, including tablets and smartphones, with ease. 
• This makes it a lot easier to migrate manual processes to the electronic world as the need to deploy expensive infrastructures no longer exists; all is needed is a wireless network, which is often already in place. 
• The device proliferation also simplifies real-time involvement in the process, making all parties aware of what is happening at any given time. 
• Although planning needs to remain a cornerstone of GMP, being aware of issues as they occur provides a level of understanding that often cannot be achieved after the fact, thus leading to better decision making.
• Although some manufacturers are still wary about the associated challenges that go together with implementing a new system, breaking the project down into phases, starting with the functionality that will provide the biggest return, can make the whole process much more approachable. 
• Indeed, once the organization has created a success story and brought all its stakeholders on board, it’s easier to define the scope of the remaining areas.

The 3 Pillars of an MES:

• Establishing a plan and staying on schedule

  The system takes your input – production shifts/times, production goals, etc. and calculates your TAKT time. Operators see real-time progress on dashboard graphics, knowing the progress at every moment.

• Enforcing a repeatable process

  Knowing your process is being followed exactly as defined provides the ultimate peace of mind. Every step, from fastening to product routing, is nailed just as you defined it time after time.

• Creating a rich data set:

  Capturing data is one thing; being able to act on that data is really the key to driving improvement initiatives. Use your business intelligence platform, explore your data set, and identify and solve your hidden inefficiencies.

All three of these MES pillars are used to help you reach productivity and quality goals by:

• Solving production scheduling challenges
• Discovering and sharing your best operators’ insights
• Uncovering inefficiencies in your process and fixing them
• Reducing the exhausting task of putting out fires
• Establishing a continuous improvement philosophy
• Increasing operator engagement and dedication

MES Is For All Industries:

• Manufacturing execution systems (MES) are being used across industries, and are seen in a number of the discrete, batch, and continuous process manufacturing industries including semiconductor, aerospace, metals, plastics electronics, medical devices, automotive, pharmaceuticals, glass, and more. 
• A Manufacturing Execution System (MES) with a configurable platform adapts to the users’ business without custom code, and has an open SOA architecture designed for ease of integration to enterprise applications and shop floor automation.

But Why Should Pharma And Biotech Companies Use An MES?

What is MES in pharma?

• Manufacturing Execution Systems (MES) enable pharmaceutical manufacturers to improve performance and reduce operational cost, while simultaneously increasing compliance with regulatory requirements.
• MES digitizes your pharma and biotech production.  In today’s intense economic conditions, spiraling overheads are compelling manufacturers to optimize their production processes, leading to a demand for new approaches that can improve efficiency and better utilize expensive resources.
• As the industry evolves and the complexity of managing drug manufacturing programs increases, MES technology has also advanced at considerable speed and come a long way in terms of functionality and flexibility.
• MES solutions enable manufacturers to plan, direct, track and analyze every stage of their operations. 
• Today, these systems provide real-time management capabilities, full support to replace paper documents with electronic documentation (electronic batch records [EBRs] and electronic logbooks [eLogbooks]), and seamless integration with enterprise resource planning (ERP) and automation systems.
• They also offer compatibility with multiple plug-in applications, meaning they can accommodate the most complex workflows into their design while contributing new levels of adaptability through modularity and off-the-shelf configuration. 
• MES technology is equipping manufacturers with comprehensive data to help with proper recipe management and electronic batch processing recording, reducing the risk of production issues and, most importantly, improving product quality. And they are an important prerequisite for digitization and Pharma 4.0.
• At the highest level, MES needs integration between the ERP and shop floor automation.

What Is The MES System In SAP?

• SAP maintains the record of materials, BOM, routings, and orders; the MES maintains the records/transactions such as WIP (work in progress). 
• For implementing the MES, the consultant has to perform a detailed analysis of MES requirements such that they can be mapped with the manufacturing environment. 
• The consultant has to perform the analysis of the integration with SAP PP since there is an overlap of functionality offered by SAP and MES software

Companies like Atachi Systems have worked with several top global pharma manufacturing companies who have used the other MES platforms and struggled to get the value out of these MES platforms; hence we call them legacy platforms. 

• Atachi NGIMES platform has eliminated all the pain points that companies are struggling with legacy platforms. 
• Their platform is the only MES solution entirely built on the SAP HANA platform that leverages Big Data analytics and AI, which need tomorrow’s business. 

Because of these reasons, Atachi systems have been listed as TOP Global MES platforms by several research firms in the last few years, repeatedly.

What are Atachi solutions offerings for Pharma 4.0?

• They are helping the pharma manufacturers to get them on to the Pharma 4.0 journey and realize complete business agility (quickly and cost-effectively) for their customers with real-time insights. 
• As part of their platform, they offer EBMR, logbooks, DMS, CAPA, IIOT, TMS, Supplier quality management, Real-time analytics, Mobility, big data, and AI at a single license cost. 
• Users don’t need to pay separately for each functionality; everything comes as a single package in a USE-AS-NEEDED approach.

MES is a Holistic Solution:

MES isn’t a stop-gap, quick-fix, or miracle solution (although it can seem magical at times). It’s really a system for digitally transforming your entire facility’s manufacturing execution.

You need to explore how an MES implementation will influence your established processes and how those processes may change. That requires upfront thought about change management within your organization. MES software is powerful and dynamic, yet it needs everyone to be on board to make it effective.

NGIMES is one of the top 10 Global MES solutions for Pharma companies in the world.
– Pharma MES SWOT analysis by global research firms.

Atachi Systems provides manufacturing companies with o seamless,  cloud-based manufacturing Execution System – NGIMES. NGIMES is the Next Generation Integrated Manufacturing Execution Systems. Atachi Systems’ experience in deploying MES for pharmaceutical manufacturing companies for several years in a row is a testimonial on its own. Put simply, Atachi Systems understands the importance of deploying on MES system that is strategic to its core manufacturing requirements, yet cost effective to maintain and run for years to come! Our clients call it the Atachi Advantage. NGIMES is highly configurable Manufacturing Execution System (MES) for Pharmaceutical Manufacturing.

NGIMES can be quickly deployed for the bulk drugs, API, formulation and packaging sections of the pharmaceutical manufacturing companies. Meet market demands, increase output and raise ROI by utilizing on MES-in-the-cloud solution from Atachi. From the shop floor to on office, vital data can   be viewed   anywhere. And because the information is real-time, decision-making con be done to creole instant results. It’s all about speed and production with compliance in Pharma manufacturing and nobody is quicker or generates better results than Atachi NGIMES.

Interview:

Why the Indian pharma companies need to digitize their operations or move to the Pharma 4.0?

A. Right now, the Indian pharma market is under the highest pressure because of the following reasons:

I. Emerging global generic drug exports to the developed countries

ii. if we do not ensure that our manufacturing processes are compliant with the FDA regulations, Indian pharma companies will lose the market opportunities, which is multi-billion dollars.

iii. The FDA Process is getting stringent every day, and FDA compliance will be enforced for all pharma companies exporting to the developed countries.

iv. Compliance is the only thing that will let you to export drugs to these countries

v. Warning letters are very expensive, which can cause product recalls, plant shutdowns, etc.

Q: Let us say if an Indian pharma company received an FDA or Compliance warning letter how quickly Atachi can help? What is your approach?

A. We have been deploying the MES solutions in the pharma industry for the last 14 years. The best

approach is to plug-in or integrate all the PLC’s and ensure that the data is captured in real-time, in other words, we implement the IIOT (Industrial Internet of Things) first. This deployment typically takes 10-12 weeks, in this phase we capture the data in real-time and ensure that there are no data integrity issues with the process data.

b. In the second phase, we deploy the MES solution, which is also called as EBMR (Electronic Batch Manufacturing Record), where all the manufacturing processes are digitized end-to- end. It will eliminate human errors, and once again, the data integrity issues are resolved.

c. At every stage of the processes, we capture the electronic signatures of the associates and generate the real time alerts via SMS and email for any process deviations and ensure that the only qualified batches are shipped out to the customers.

Q: What is so unique about Atachi systems and why do you think, Atachi is a perfect fit for Indian pharma companies?

A: We are bringing 14 years of global pharma manufacturing digitization expertise to Indian pharma companies. It distinguishes us from the local MES solutions providers. Atachi has worked with several top global pharma manufacturing companies who have used the other MES platforms and struggled to get the value out of these MES platforms; hence we call them legacy platforms. Atachi NGIMES platform has eliminated all the pain points that companies are struggling with legacy platforms. Our platform is the only MES solution entirely built on SAP HANA platform that leverages Big Data analytics and AI, which need tomorrow’s business. Because of these reasons, Atachi systems has been listed as TOP Global MES platforms by several research firms in the last few years, repeatedly.

Q: What are Atachi solutions offerings for Pharma 4.0?

A. We are the End-To-End Manufacturing Digitization Platform company helping the pharma manufacturers to get them on to the Pharma 4.0 journey and realize complete business agility (quickly and cost-effectively) for their customers with real-time insights. As part of our platform, we offer EBMR, eLogBooks, DMS, CAPA, IIOT, TMS, Supplier quality management, Real-time analytics, Mobility, big data, and AI at a single license cost. Users don’t need to pay separately for each functionality; everything comes as a single package in a USE-AS-NEEDED approach.

Q: Given that you are offering so many modules, are you charging the customer for all these modules?

A.  No, Absolutely not! We are very inexpensive;

On average, we charge 1/4th of top global MES platforms.

b. Let me give an example, one of our customers was using a legacy MES platform and paid a few hundred thousand dollars to customize and integrate their MES platform with their ERP systems. When we implemented our solution, that is natively built in SAP HANA platform, our total MES solution costed the customer 1/6th of their (prior MES -ERP) integration cost, not the licensing cost or implementation cost. We deployed the entire solution 1/6th of what they paid just for (MES-ERP) integration. Our complete solution is much cheaper because we built everything on modern technology, and you need any additional hardware/server or middleware. So, our TCO is much lower than anyone else.

Q: What are the other unique features that will make you standout or go-to-the-solution-provider?

A.  We are proud to say that our solution is highly scalable and seamlessly integrates with on-premises, cloud, and hybrid third party applications. Our implementation timelines are typically down to 50% – 65% less than the legacy MES platforms’ deployment times. Atachi NGIMES platform saves a significant amount of time and effort for validations of MES applications for pharma manufactures.

Q: I heard from Indian pharma community, when they are committed to deploy MES systems, they do not get much ROI? Is it true?

A. This statement is true to some extent. Actually,

we have a lot of legacy systems in foreign markets. These legacy systems take lot of time, effort, and money to deploy because these legacy MES systems need tedious installations, validations, and expensive post go-live support. When we talk about Indian pharma, a lot of the MES solutions are point solutions, which means they provide piece by piece functionality or partial functionalities. These solutions provide quick relief, and many times seemed to be cheaper, but customers end up with a lot of integration and quick upgrade costs. Also, these solutions do not give customers a holistic view of manufacturing. The end result is still data integrity and compliance problems unresolved, even after 2 to 3 years of journey. Hence a lot of Indian pharma manufacturers are frustrated with these legacy systems and point solutions. Atachi systems solution is different; Our MES is built on modern technology and provides a holistic view of the manufacturing. We also work with the customers, hand-in-hand and provide data analytics on where they are losing quality, availability, and throughput, etc. For example, we worked with one of the top pharma company in the US; They implemented our Atachi NGIMES -IIOT solution and uncovered the 10% of hidden factory by closely working with us. What is the benefit? They are able to save 200 to 300 Million dollars, bottom line by improving the availability, quality, and throughput.

Q: What are the typical steps for a pharma company to implement your MES solution?

A. We will start with an initial meeting with customer, followed by factory visit and then we do a POC for one production line. We do it completely free; they do not need to pay any implementation or product cost. They can experience the product and if they are satisfied, we can go ahead and do the complete implementation for the factory, based on what the customer needs EBMR, IIOT, DMS, QMS etc. There are no hidden costs for all these products. The entire platform is available for customer.

Q: How about eLogBooks for Pharma manufacturers?
Do you provide that along with other solutions? We do not charge the customers for the eLogBooks. If some Pharma companies need eLogBooks, then they can reach out to Atachi systems! It is completely free. The only thing you need to pay a one-time cost for customization and implementation.