Drug Safety Assurance

The pharmaceutical value chain is under constant pressure with increasing regulations mandated by various Governments/federations across the Globe. The age of ecosystem is witnessing the link between patient and pharmaceutical organisation blurring. Manufacturing individualised drugs on a smaller scale have unique challenges as the manufacturing organisation will have to secure a much bigger market with multiple avenues and distributed operations. It is critical for Life Sciences organisations to collect information from early stages of drug development to future treatment, benefits, potential side effects and in turn develop countermeasures to mitigate the side effects. And information collection continues long after the drug is made available in the market.
Plant Modernisation. Smart Manufacturing.
Life Sciences organisations are looking at innovative approaches to maximise the ROI while keeping costs at bay. Ability to scale-up processes to respond quickly to market demands and maintain sustainable competitive advantages are vital. Getting to this state of agility would require legacy systems to be updated and where required replacements to be made to ensure interoperability with other manufacturing assets in the enterprise. The need to drive down operational costs while maximising productivity, security is equally vital. The data that resides in siloed systems require need to be extracted to the additional integration layer so as to serve as a reusable template to help drive standardisation across.
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Intelligent Batch Analysis
As with any manufacturing plants, attaining repeatable quality across efficient batch executions is desirable in this industry. A rich analysis of batch and product execution to understand the golden Batch standard by knowing the energy, materials used. It is critical to understand the efficiency of batch execution at your fingertips.
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Dealing with Variations in Recipes
Increased activity in Pharmacogenomics to study an individual’s response to drug therapy leads to more variations in product recipes. This calls for a scalable and agile formula management to handle complex procedure modeling and execution ensuring simplified recipe deployment, optimisation, and execution leading to faster response times and reduced costs.
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Product Standardisation
Life Sciences organisations are steering towards MES systems to not only optimise manufacturing quality but to curb costs and expedite time-to-market. An integrated approach provides a Life Sciences organisation with many benefits ranging from a completely paperless process, single source of process data and allowing faster corrective actions should they occur. In a nutshell, Life Sciences organisation realises operational excellence, effective supply chain and sustainable competitive advantage.
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Asset Availability and Reliability
Drive Operational Excellence by improving the Asset reliability and availability to match the market demands. Asset reliability is one of the rising concern in the US and developing nations and enterprises are gearing towards Digitisation of various processes in the Life Science industry.  Solutions to not only predict the performance of assets, but conditional maintenance not only reduces the unscheduled downtime but improves the planned maintenance of these assets.
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Enforce Operational Procedures for Consistency and Accountability
From Drug discovery to drug development to distribution, automated workflows play a critical part in not only enforcing consistency of batch/process execution but to enforce procedures for accountability and benchmark operational processes as best practices. A system to unify processes integrates multiple disjointed systems while adhering to the compliance and regulatory mandates. Automated notifications in case of events/conditions, approval workflow to release a new product, specifications change request, documenting process order change etc.
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Track and Trace
Pharmaceutical manufacturers across the Globe are mandated to adopt Serialisation and soon all products of pharmaceutical re-packagers / distributors must be serialised according to the Drug Supply Chain Security Act (DSCSA) by FDA. North America and Europe come first due to various gaps in the existing solutions and lack of exhaustive reporting, analytics and tracking capabilities. This raises a unique opportunity to include serialisation capability to assign unique traceable numbers to individual items or units, as a separate line or as a part of existing packaging line.  Need to have a full feature rich solution in line with GS1 standards to cater the Serialisation mandates across the production site is the need of the hour.
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Data Integrity
Being a highly regulated industry, Life Sciences organisations are under constant scrutiny of the regulatory bodies about the data quality and data storage practices. Owing to the rise in violations and data issues in pharmaceutical manufacturing companies, regulators are focused on enforcing principles and practices keeping the interests of modern day patient in mind. Ability to access the collected, verified and validated data from multiple sources at any time helps Life Sciences organisations to not only respond to regulatory demands faster but also make use of the consolidated data to continually improve decisions.
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Regulatory compliance services
Compliance Services is a team of skilled and experienced people providing most pharmaceutical process automation life-cycle services. From the initial feasibility study, going through risk analysis and planning, the team works in partnership with Customers to reach their targets, minimising the time to market and increasing their confidence in a ‘right the first time’ implementation. The compliance/regulatory consulting services span through the entire plant lifecycle with a unique approach that results in faster validation.
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