Computer software

We specialize in IA and non-AI Computer System Validation, equipment validation, utilities qualification, and IT/OT infrastructure qualification. Our services comply with the regulatory standards of the EMA, FDA, WHO, and other key Life Science authorities across Europe and the Americas. With a proven trac...

The OC 11 Platform is not just another software; it's the next generation of Global GxP and Data Integrity solutions. It's designed to revolutionize how GxP records are generated and to ensure users comply with global GxP and Data Integrity regulatory requirements..

Convert any Word form i...

MasterControl Inc. is the most trusted provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is to help our customers bring life-changing products to more people sooner. MasterControl Quality Excellence is our flagship quality management syste...

Studio enables you to design labels in 3D to perfectly fit structural packaging designs. Its patented print modeling technology uses the actual production assets, so your 3D models and images are in sync with the printed packaging, creating a digital twin. Using Studio to design packaging artwork increases...

YAVEON ProBatch is a cloud-based ERP solution built on Microsoft Business Central, offering specialized features for pharmaceutical companies, such as batch management (including traceability), quality control, recipe management and more. With YAVEON's validation consulting, experts are at your side to val...

SoftGroup® SaTT Site Controller is a centralized serialization software system for the management of the serialization and aggregation processes. The Site management software by SoftGroup provides a complete solution for managing the whole production of the factory and preparing serialization and aggregati...

Global Verification & Validation is a SaaS solution for Life Science companies that complies with EMA/FDA. FIVE Validation developed a SaaS platform that allows validation studies to proceed 6x faster than a manual (electronic or paper-based) process.

Global Verification & Validation is a SaaS solution for Life Science companies that complies with EMA/FDA. FIVE Validation developed a SaaS platform that allows AI and traditional validation studies to proceed 6x faster than a manual (electronic or paper-based) process.

MasterControl Inc. provides cloud-based software to empower manufacturers in life sciences and other regulated industries to digitize and streamline their processes to reduce errors on the shop floor. Our mission is to help our customers bring life-changing products to more people sooner. Manufacturing Exc...

WebCenter, is a comprehensive packaging and artwork management solution. It allows organizations to control the quality and accuracy of packaging and label assets from a single source throughout the entire lifecycle - from briefing to print-ready file. The platform efficiently guides teams through the proc...

Cape Pack enables you to optimize your primary product size for shipping, create new case sizes, build efficient pallet patterns, analyze compression strength of cases and pallets, and improve material and cube utilization.

ArtiosCAD is a structural design software that helps packaging teams design virtual prototypes and handles manufacturing operations for POP displays. Creating 3D packaging designs and resizing them to fit a product helps designers check the physical limitations of their creations, reducing manual processes...

SoftGroup® SaTT Gateway is the most user-friendly and fully automated SaaS software for meeting compliance for traceability and serialization. It fully supports the EU FMD, Asl belgisi, and MDLP requirements as well as other implemented and emerging compliance regulations for each member of the supply chai...

SoftGroup® SaTT Line Controller is serialization software installed on a serialization machine, which controls the process of printing and verifying the process of the printed templates with and without serialization for each batch.

With SoftGroup® SaTT Communication Cloud you can securely communicate across your business network. With fully automated communication or with XML file exchange through the sFTP service, we can help you to enhance your supply chain visibility by keeping your costs to a minimum and reducing human errors.

Commercialization strategies evolve, supply chains expand and production rates accelerate. Things change. You adapt. But the only way to take control of your future is to double down on quality. It's the ultimate game changer. That's why you need MasterControl; the platform for quality.

MasterControl delivers the next level of manufacturing excellence by bridging the gap between performance and quality with digital production records that finally let you go 100% paperless.

Quality is the essential ingredient in any product. It can mean the difference between getting an innovation to market – or putting the whole project on hold. Quality is the key differentiator that builds trust with customers and keeps them coming back for more. But maintaining consistent quality throughou...

Sarjen Systems’ QEdge is an enterprise-wide Quality Management System (QMS) specifically designed for pharmaceutical manufacturing. This risk-based QMS offers a comprehensive suite of solutions, including:
• Process Control • Document Control & Issuance • Training Management System • Ve...

KnowledgeNET is a global dossier publishing & management software empowering pharma industries to achieve regulatory compliance efficiently.
• eCTD Publishing: DMF | ASMF | CEP | ANDA | IND | BLA | PADER | PSUR | 510(K) • CTD/ ACTD and Regional Submissions • Query and Life Cycle Management ...