Computer software

The serialisation solution must integrate production lines, partners, customers & suppliers - this means comprehensive integration, adaptation of processes and high security measures. Whether at the intersections between ERP software and production and packaging machines, to the systems of ex...

AI-enabled, cloud-ready,360 pharmacovigilance solution for safety database management. An end-to-end globally compliant safety software for Drugs, Devices, Vaccines and Combinational products from case intake to submissions and reporting. • Case Intake • Case Processing • Case Submission • Risk Manage...

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.

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...

AmpleLogic QMS Software automates quality processes like CAPA, Change Control, Deviation, OOS, OOT, Audit Management, Vendor Qualification in pharma and life-science manufacturing companies who do it manually. All the AmpleLogic modules are 21 CFR Part 11 and EU annexure 11 compliant. Automating QMS helps ...

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...

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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...

Lab Iconics ELN designed to manage the whole laboratory experiments, projects, forms and templates, and effectively manage the digital track of inventories. 

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 ...

Sarjen Systems' ProcessXE is a SMART manufacturing solution tailored for the pharmaceutical industry. This solution provides the following offerings
• Weighing & Dispensing Management • Electronic Batch Manufacturing Record​​ • Electronic Batch Packaging Record​ • Equipment Qualification...

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...

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...

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.

AmpleLogic GMP Learning Management software is built to manage pharma specific employee training and Training life cycle starting from Induction till employee’s total tenure in the organisation as per 21 CFR Part 11, EU ANNEX, GMP and other regulatory requirements. AmpleLogic Biochemical Learnin...

Challenges like lack of proper document escalation flow, improper document revision and getting document signatures made AmpleLogic to design and develop Electronic document management system. In Pharmaceutical companies each and every activity within a GMP regulated environment such as US FDA, MHRA ...

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...

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.

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.