With increasing demands for effective collaboration, faster time to market and maximum security for systems and products, the stakes are higher than ever. In full compliance with business standards, government regulations and global regulatory requirements, Cegeka combines Microsoft Dynamics 365 solutions with industry-specific expertise, enabling you to overcome the challenges in the sector and become a truly connected company.
The challenges of compliance and validation in pharma and life sciences are becoming increasingly complex and demanding. Pharmaceutical manufacturers and distributors must achieve and maintain compliance with GxP regulations and guidelines from international agencies and organizations (EMA, FDA, WHO, ICH, etc.)..
Security risks are rising along with the complexity of processes and systems. Your ERP must support optimal security, full traceability and electronic signature capabilities in compliance with international standards (e.g. 21 CFR Part 11 from the US Food and Drug Administration).
The need for effective and efficient cooperation, communication and connection beyond company and country borders is increasing in pharma & life sciences. This requires flexible and easy-to-use collaboration tools to exchange information and data with third parties.
Combining scientific innovation with patient-centric business needs means that time to market – from front end to clinical trials – is often under pressure. There is an increasing demand to leverage agile methodologies and technologies to increase efficiency, accelerate outcomes and proactively respond to ever-changing market & competitor conditions.
21 CFR Part 11 compliant electronic signature, extended mobile device security, approval workflows for GxP critical processes, advanced shelf life date management, management of QP requirements for batch release and shipment approval, etc.
Lot and container/drum management, approved customer/vendor/manufacturer list, label printing and reprinting, forward & backward lot traceability, recall & complaint management, etc.
Weighing & dispensing management, real-time interface with weighing scales, reconciliation of production components, material consumption, tolerance management, rework & reprocess order management, shop floor mobile capabilities and integration with Microsoft Dynamics 365 Guide and HoloLens, etc.
Time/Temperature monitoring for controlled products, advanced picking & put-away strategies, RF scanning & barcoding capabilities for procurement, production, sales and internal logistics, etc.
Vendor & Manufacturer approval & qualification, advanced specification/test group management, statistical test criteria, periodic/skip/reduced testing, quality orders for purchase, production, transfer, sales & RMA’s, decimal precision for test results, peer review of test results, sampling management, etc.
Accounts payable, accounts receivable, general ledger, budget management, credit and collections, fixed asset management, cash & bank management, cost price management, electronic invoicing, financial reporting, etc.
Join experts from Microsoft, Cegeka, and Epista as they discuss how an ERP system can create even more business value and help Pharma & Life Sciences companies adapt to changing environments.
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