Competence Area

Product Safety

Incorrect use and inadequate monitoring of many medical products and chemical substances can cause adverse effects. For this reason, greater focus and emphasis on the safe use of such products and ingredients is critical. Product Safety is a major question to be addressed during the full R&D and production cycle. This field integrates closely with all other regulatory practice groups.

lexoro can automate time consuming safety tasks and studies and integrate data from multiple sources into pre-defined workflows, documents and reports. A.I. tools further enrich this process in offering intelligent monitoring, classification and alert services to all product safety guidelines and standard procedures.

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Benefits of Intelligent Automation in Product Safety

We offer end-to-end support in the area of clinical trials and related studies. We free you from routine work and give you tools to monitor and manage the full product-life-cycle.

  • Automate all documents related to product-safety that are needed within the different regulatory-settings
  • Automate all information needed in the preparation of PSURs
  • Automatde risk analysis of manufacturing facilities
  • Automated auditing of product safety practices
  • Generate high-risk product safety investigations to help determine root causes
  • Create and submit relevant PSUR documents
  • Generating safety reports (IEC 60601)
  • Generating periodic safety update reports (PSUR)
  • Generate reports of Field Safety Corrective Actions (FSCA)
  • Generate reports of Serious Adverse Events (SAE)

Cost reduction

Quality increase

Relief for employees

Experts focused on their activities

Standardization of processes

Increase productivity

Get rid of routine work?

Lets talk about it. Our Solution Experts can give you further insight into Intelligent Automation options along the entire Compliance-Chain.

Let BOTs and A.I. help you in time consuming tasks and refocus your time on real quality work.

Tell us about your wildest automation wishes – and we turn them into reality!

Your contact person

Michael Fischbäck

Business Development Consultant

Sign up today for your initial Brainstorming.

Intelligent Automation along the entire Compliance-Chain

We enable all critical areas of the value chain with automated solutions. All regulatory workflows, tasks, documents and forms can be integrated into a highly automated suite. Check out your specific area of interest and get inspired by concrete use-cases we delivered to our clients in the MedTech, Pharmaceutical and Chemical industries.