Computer software

Validation of computerized systems (CSV) according to GxP Guidelines has been a basic requirement in the life science industry for many years now. However, as the complexity of the IT landscape and the degree of automation has increased, the effort required to keep compliance has risen as well. Of cour...

Genixian App is a CRM, especially build for Pharmaceuticals to empower its Sales Fields Force. 

PvEdge 360* End-To-End safety database provides comprehensive analyses of adverse events arising from the use of pharmaceutical products (Drug, Medical Device or Therapy, Vaccine). It is an advanced Pharmacovigilance solution that helps combat the complexity of the safety data and comprehensively cater...

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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. 

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 ...

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...

eCTD Publishing and  life cycle management :
KnowledgeNET, Publishing solution which create, compile, manage & publish your IND, NDA, ANDA, DMF, ASMF and CEP submissions effortlessly,

KnowledgeNET is fully compliant with ectd module 1 specifications EU, US...

QEdge is an enterprise-wide Risk based, Quality management Software to ensure product Quality and regulatory compliance, and Audit Readiness.

·QEdge eQMS has configured 60 + Process

Data Integrity Part 11 (21 CFR Part 11, Annex 11) compliant Risk ...

Process-XE is one of the smartest AI infused, cloud enabled manufacturing process automation platform empowering you to be in total control of your manufacturing process, data and be assured of global manufacturing compliance standards and compliance. Consumer grade UI has successfully enabled adoption acr...

Lab Iconics ADBS is automated backup scheduling software which helps in managing the data backups and archives, in incremental, differential and full backup with encryption and log.  

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 ...

The major problem faced by pharmaceutical companies and labs in column usage is maintaining the continuous updates on cumulative injections and duplicate mapping of the same column for different products at the same time. AmpleLogic HPLC Column Management offers users to create an inventory of their HPLC c...

Stability Schedule Calendar helps to keep track of different schedules of the testing with reminders and escalations.Details like Stability Protocol reference number, Stability Protocol Version etc. can be maintained.Separate flow for each Stability Protocol, Stability Initiation Protocol and Incubatio...

Soterius offers its in-house tool, UNITYdx, which automates the sending and tracking of SUSAR notifications to the Principal Investigators (PI) during a clinical trial. System integration and standardization allow UNITYdx platform to work with any of the database systems. Continuous tracking provides audit...

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...

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...

Our in-house cost-effective Digital solutions keep you connected at every stage, no matter where in the world your studies run.

Our Digital Solutions are integrated solutions, Regulatory compliant, and it can handle all type of clinical trials.

Our Digital Solution portfolio consist o...