Atachi Software Systems: Deploying Accelerated MES Systems Ensuring Data Integrity
Pharmaceutical manufacturers are constantly competing with each other, not to be just on the top but are pressurized to adhere to stringent regulatory manufacturing requirements. Catering to domestic and several international markets, the pricing is highly competitive for domestic markets while the international markets demand strict compliance. MES is the vital system for accomplishing the compliance faster and easier. Software developers make strenuous efforts to quickly deploy the solutions for the industry, simultaneously perplexed manufacturers are figuring out which MES system fits into their ecosystem. Ultimately, whichever MES system has been invested in, there is a lengthy road map of evaluation & selection, implementation, validation, maintenance, hardware and software life-cycle management and integration of these systems and building the dashboards and dataware houses which may lead to a 10 year roadmap for these MES systems. Addressing these challenges head on, Atachi Software Systems, established in 2007, built NGIMES a cloud-based MES that is fast to deploy. NGIMES cuts down the TCO, validation times & efforts and simply lets the pharmaceutical companies focus on the innovation and deliver faster quality drugs to the market. Thus by far, allowing manufacturers to reap the benefits of the MES system.
Atachi eBMR captures and displays instantaneously all the batch information that is needed for compliance measures
Securely Accessing Data
NGIMES doesn’t need any IT infrastructure as the NGIMES is completely provided as SAAS. NGIMES is highly secure as it runs on the SAP data centers and has thoroughly in-grained security built into the application. NGIMES is highly configurable that means saving lot of deployment time. By having the SAAS model, customers do not have to invest their money and time in IQ and OQ of the systems. NGIMES is a true performance accelerator with reduction in investment, validation time and allocation of human resources. With NGIMES, data is created, modified and viewed only through NGIMES and there is no direct database access for any users. The Database administration is fully automated and completely performed by SAP Data centers as a service. For any administrative tasks performed by Atachi, the company maintains the complete documentation and will provide it for any auditing purposes. This leaves the customers with complete data integrity assured.
Meeting the Compliance Guidelines
Another dent to the adoption of MES systems, the FDA adding more clarity for their guidelines and enforcing the manufacturers to ensure that cGMP and 21 CFR Part11 regulations are clearly understood and adopted. Atachi thoroughly understands this and have integrated the FDA guidelines into the NGIMES so that perfect alignment of business objectives and compliance guidelines goes together without too much time and investment. Atachi NGIMES brings the eBMR that is highly configurable for all the pharma manufacturers. Atachi eBMR captures and displays instantaneously all the batch information that is needed for compliance measures.
So in essence, Atachi Systems provides discrete manufacturing companies with a seamless, cloud-based Manufacturing Execution System that reduces dependencies on infrastructure, lowers maintenance costs, and improves access to real-time visibility of shop-floor operations for engineers and managers at all levels and aims to continue working on providing the complete end-to-end shop floor solutions for the pharmaceutical industry.
NGIMES doesn’t need any IT infrastructure as the NGIMES is completely provided as SAAS. NGIMES is highly secure as it runs on the SAP data centers and has thoroughly in-grained security built into the application. NGIMES is highly configurable that means saving lot of deployment time. By having the SAAS model, customers do not have to invest their money and time in IQ and OQ of the systems. NGIMES is a true performance accelerator with reduction in investment, validation time and allocation of human resources. With NGIMES, data is created, modified and viewed only through NGIMES and there is no direct database access for any users. The Database administration is fully automated and completely performed by SAP Data centers as a service. For any administrative tasks performed by Atachi, the company maintains the complete documentation and will provide it for any auditing purposes. This leaves the customers with complete data integrity assured.
Meeting the Compliance Guidelines
Another dent to the adoption of MES systems, the FDA adding more clarity for their guidelines and enforcing the manufacturers to ensure that cGMP and 21 CFR Part11 regulations are clearly understood and adopted. Atachi thoroughly understands this and have integrated the FDA guidelines into the NGIMES so that perfect alignment of business objectives and compliance guidelines goes together without too much time and investment. Atachi NGIMES brings the eBMR that is highly configurable for all the pharma manufacturers. Atachi eBMR captures and displays instantaneously all the batch information that is needed for compliance measures.
So in essence, Atachi Systems provides discrete manufacturing companies with a seamless, cloud-based Manufacturing Execution System that reduces dependencies on infrastructure, lowers maintenance costs, and improves access to real-time visibility of shop-floor operations for engineers and managers at all levels and aims to continue working on providing the complete end-to-end shop floor solutions for the pharmaceutical industry.
