Mekala.S.Rao founded Atachi Systems in 2007 to deliver robust digitization solutions for Lifesciences, manufacturing industries. Mekala’s unique expertise lies in bringing agility, significantly reducing time-to-value to manufacturers by offering them end-to-end customized applications with 2x faster deployments ensuring rapid ROI. In this Interview Mekala.S.Rao narrates his journey in digitizing the pharmaceutical manufacturing.
Can you give us a brief history about your company?
Mekala.S.Rao: Atachi Systems provides Pharma, Medical Device and other manufacturing companies with seamless cloud-based next-generation integrated MES – NGIMES. NGIMES brings the complete portfolio of products to digitize the manufacturing operations. Atachi was founded in 2007 in San Jose, California and for far more than a decade Atachi helped several Fortune 500 companies to digitize their manufacturing processes with state-of-art Digital Transformation solutions.
How is your company helping the pharmaceutical industry in digitalization?
Mekala.S.Rao: Pharmaceutical manufacturers are under continuous pressure to remain competitive while meeting the stringent regulatory manufacturing requirements. These manufacturing requirements range from simple electronic record keeping to complex data assuring consistently the reliability of the manufacturing processes, equipment and people’s training, raw material quality, sampling plans, root-cause-analysis, product’s deviations, etc. 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 an 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 the “premiere” MES for pharmaceutical manufacturing companies that uses SAP ERP. It helps comply with 21CFR Part 11 electronic signatures, FDA audits, validation and confirms to US FDA cGMP requirements. Furthermore, pharmaceutical companies can take advantage of the cloud based MES (NGIMES) to contain costs while delivering accelerated performance with its in-memory computing platform. Below image covers all the MES functionalities detailed in ISA-95 model that Atachi NGIMES brings.
We handle complete digitization of Pharma facilities, from small size players to large enterprises.
Our solutions diligently fit for CROs, CDMOs, R&D facilities in leveraging robust digital technologies for better outcomes and reducing R&D expenditures, being inline with compliance.
One of your primary product is eBMR, tell us more about it? Why should pharmaceutical companies go for eBMR instead of paper BMR?
Mekala.S.Rao: Today, lot of pharma manufacturers, especially Indian Pharma manufacturers capture lot of information in their BMR on paper. When they try to digitize this paper bmr into eBMR using the international eBMR platforms, this functionalities that they are capturing on paper is not available for one single cost or license. What does it mean? When you generate a BMR, the BMR template needs to be created at first and that needs to be reviewed and approved by QA department. This functionality is sold as a separate package by some MES vendors. As part of the preparation of the raw materials prior to production, warehouse performs weighing and dispensing. This functionality is offered as a standalone package by lot of MES vendors and small Indian software firms. When the pharma manufacturer starts deploying the functionality one by one, the integration of these functionalities becomes challenge. Some MES platforms have integration issues with the machinery on the production floors hence demanding the situation of retrofitting these machineries or upgrading the machineries with 3rd party OPC software or IIOT gateways. This is becoming a challenge for the Pharma manufacturers in digitizing their paper based BMR. This is the key differentiator with Atachi NGIMES platform, it is bundled with all the functionalities. We do not distinguish weighing and dispensing as a separate package, creating Master Batch Records or Recipe Management as a separate package. This is all included as part of the eBMR.
Our eBMR diligently handles the process flow right from raw material procurement till dispatch. Recipe information, Engineering Diagrams, SOPs, Yield Conciliations & Reconciliations, eSignatures, On-top analytics etc make our eBMR a true companion for every pharma manufacturer with a very cost-effective pricing model.
Pharma companies operate in one of most dynamic environments, ever-changing regulations and every manufacturer needs to be abreast of these happenings. A digital eBMR, enhances operational efficiency, minimises human errors, saves enormous work-man hours, enhances compliance and the bottom-line being manifolded Profitability.
Is your eBMR compliant with regulations of various global regulatory agencies ?
Mekala.S.Rao: Our eBMR is fully cGMP, FDA Part 11, MHRA & EMA compliant. It truly empowers every manufacturer out there to focus on their core business without worrying about compliance/export hassles.
What is the idea behind elogbook ?
Mekala.S.Rao: If you look at the Indian pharma industry, many pharma manufacturing companies still use paper-based logbooks and records. These companies face a lot of challenges and compliance issues in the paper-based logbooks. Even though they record all the details about equipment cleaning, calibration, maintenance schedules, packing, weighing, and dispensing in a paper-based logbook; It’s prone to compliance issues, human errors, misplacement, and loss of productivity. They also need to validate the logs manually according to SOP procedures and operational requirements. It is quite a challenging and daunting task. What is draining the value for Pharma manufacturing companies is not realizing the value associated with capturing the information and generating its insights. It means the industry has been developing the logbooks per SOP’s only for the sake of auditors and CGMP Practices; Even then, many Pharma manufacturing companies are getting FDA warning letters because of cleanliness, data integrity, calibration, and other issues.
Our eLogbooks, diligently handles all the parameters viz., QA/QC, Equipment wise, Area Cleaning logs and removes the burden of manual entry, storage and other unwanted hassles – equipping manufacturers with a holistic view of the process flow.
How do you see digitalization changing the pharmaceutical manufacturing activities?
Mekala.S.Rao: The pharma industry is under-going through a wave of digitalization to make true-sense of their operational assets, real-time manufacturing information and neverthless to ensure they’re inline with stringent compliance regulations. Digitalization drastically reduces product recalls, minimizes manual errors, aids the manufacturers with 360 view of shopfloor, brings ERP + Shopfloor on a same page and equips them with real-time data fostering strategic business decisions within no time. To sum up, they’d see real benefits of improvised operating efficiencies, compliance along with profitability.
Will your offering replace human effort or supplement human effort ?
Mekala.S.Rao: Atachi’s solutions always eliminates the human errors, reduces human efforts and increases productivity. Our solutions are designed keeping in view of every stakeholder in a facility, to deliver them state-of-art solutions to make their workflow more meaningful and burden free.