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Regulatory Compliance & Quality Assurance
We offer comprehensive solutions for creating and sustaining a transparent, fully auditable quality system that are equipped with timesaving and risk-reducing features, offer seamless integration with your other business systems, and provide best-in-class search capabilities.
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Major and minor versioning, excellent authoring and review engines, electronic and digital signing capabilities, change request handling and full ‘GxP’ compliance. |
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LMS (Learning Management System) with train-by-trainer activities, self-learning and employee qualifications |
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Issue, non-conformance and CAPA ensuring issues are no longer lost in emails, spreadsheets or random forms in a siloed system. |
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Audit management for internal and external audits and inspections. Validation Management for any computer system, asset or facility. |
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Supplier Assessment including recurring re-assessment and auditing. |
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Validation & Testing (IQ, OQ, PQ)
Maximize product reliability and compliance with our targeted validation and testing services. Here’s how we can assist you:
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We ensure that equipment, systems, and processes not only meet regulatory standards but also achieve operational excellence. Our tailored approach aims to enhance efficiency, minimize compliance risks, and accelerate time to market. |
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Our approach encompasses a variety of automated testing methods, designed to rigorously assess every facet of product performance and reliability. We prioritize sustainable compliance through continuous monitoring, offering real-time feedback to lower the risk of compliance issues and maintain the highest quality standards in your products. |
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We offer modular validation tool kits and empower your teams with the knowledge and support needed to effectively operate it and validate systems and assets. |
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Research, Development & Clinical Trials
Optimize your research, development, and clinical trial processes with our specialized support in these critical areas:
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Streamline your product development lifecycle and full Engineering Change Request (ECR) support, ensuring that your innovations meet both market demands and regulatory requirements efficiently. |
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We provide comprehensive risk management solutions that help organize risk and hazard management. Our services support the identification and documentation of analysis results, test results, and mitigation actions. Effective visualization is also key to understanding complex relationships between hazards, sequences of events, and harms. |
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Supply Chain Management & Serialization
We streamline your operations and increase the efficiency of your supply chain with focused solutions in these key areas:
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We implement lot tracking using serial numbers or batches as a best practice to optimize inventory management. We also help manage expiration dates or shelf lives to ensure that materials are used effectively, minimizing waste and reducing costs. |
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We help you to automate distribution planning in a systematic way to ensure the efficient delivery of goods. This encompasses the process of efficient delivery across various locations, optimizing quantities and timings to meet your needs. |
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Manufacturing
We offer comprehensive support to enhance your production processes in the following key areas:
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We can seamlessly integrate planned maintenance with production planning and execution activities. This ensures that equipment and plant maintenance occur at the right time, maintaining an optimum level of production efficiency. |
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We help you enable an easy quality inspection of work, with basic laboratory and Inspection Control using specifications for testing. |
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We provide support for revision handling, history if replacing an item, and configuration of structures for changeable features. |
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Data management & Analytics
We empower your organization to get the full potential of your data through strategic management and analytics. Here’s how we can help:
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Your business users can make effective data-driven decisions by visualizing data and using intuitive self-service dashboards to extract actionable insights. |
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Seamlessly connect with other systems like MES, LIMS, etc., to set up and manage document subscriptions within the ERP system. This facilitates the exchange of electronic documents in various formats, such as XML and flat files, and allows you to build and implement logic effectively. |
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Utilize advanced AI & ML for predictive analysis, such as forecasting and identifying trends, to anticipate future needs and drive strategic decision-making. |
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Sales & Customer Journey
We help create and deliver personalized experiences that consistently engage and delight your customers and partners in the following areas:
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Creating a unified commerce strategy that centralizes and unifies your customer and product data on a single platform. |
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Enabling orchestration across your digital supply chain by leveraging digital technologies, product information, and assets to optimize overall performance and quickly respond to changing conditions. |
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Gaining customer insights to achieve a deeper understanding of your customers, from knowing what they're looking for and the right time to reach out, to their previous interactions. |
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Providing consistent, connected, omnichannel support and service that earns and keeps your customers and partners for life. |
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IT & Security
We can help build or expand your security strategy and landscape by combining identity security with leading cybersecurity and business disciplines, crucial for protecting sensitive life sciences data.
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Directly prevent phishing attacks by giving personnel access only to what they need, when they need it. Regular reviews and the removal of unnecessary access further secure sensitive information. |
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Ensure NIS2 compliance to safeguard your infrastructure against cyber threats and breaches. Adhering to these standards is vital for protecting patient data, ensuring the integrity of clinical research, and maintaining public trust in healthcare products and services. |
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Sustainability
With sustainability becoming increasingly important in the life sciences industry, we can assist your organization in enhancing your sustainability initiatives.
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Optimize your ESG reporting strategy. We can help you assess and enhance your ESG data management, ensuring high-quality insights. |
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We help you get ready for the DPP requirements and align your strategy to it. Together we evaluate available technologies and define concrete steps towards the implementation. |
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Integrate operations to better assess usage patterns, enabling precise purchasing plans and reducing waste from expired or unused products. |
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Gain comprehensive insights into your raw materials to pinpoint and address inefficiencies in resource management and use. |
Our Customers
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Elevating your success in complex environments of product development & compliance
In addition to delivering a robust platform, we extend our expertise through targeted solutions like QMS, PLM and CAPA tools. Approaching all projects with a holistic mindset and focus on your challenges we go beyond regular IT implementations. Our focus on efficient searching, enhanced audit and compliance processes, SOP management, and improved categorizing/indexing of documents help companies achieve operational excellence.
Crafting a more sustainable future, together
For businesses aiming for a more sustainable path, getting the right insights is key. But it's not just about having those insights; it's also about knowing how to use and understand them in your industry.
Our Partners
