Monitoring of Standards, Regulations, and Guidelines
Easy Setup to Start Monitoring
1
Define your standards, regulations, and guidelines to monitor. PREXEVUS offers different ways of uploading and defining the standards.
2
Organize the standards, regulations and guidelines per product, portfolio, site or for the entire company.
3
Define the alerting intervall for daily, weekly, monthly or quaterly, and you are all done.
Choose from the simple configuration possibilities
CSV - Upload
Simply drag and drop your list of standards, regulations, and guidelines as a CSV into PREXEVUS. Done!
Expert Questionnaire
Answer a few questions and magically, all relevant standards, regulations, and guidelines are filled in.
Manually
Define all standards, regulations and guidelines manually by activating each individually.
We currently monitor the following
Standards
Up and running are:
- ISO
- IEC
- ASTM
- EN
- U.S. FDA consensus standards
- MDR / IVDR harmonized standards
Regulations
Up and running are:
- U.S. FDA 21 CFR
- Eur-Lex
Guidelines
Up and running are:
- U.S. FDA Guidelines
- European Commission Guidelines
- MEDDEV Guidelines
See what we are working on
Drafting
Implementing
- DIN Standards
- IEEE Standards
- VDI Standards
- ANSI Standards
- Swiss Regulations
- Canadian Regulations
- Australian Regulations
- Ph, Eur.
- USP
- efpia Guidelines
- EMA Guidelines
- IMDRF Guidelines
The Modules explained
Monitoring- Modules
Daily Monitoring
PREXEVUS’ data miners run every day to bring you the latest and most up-to-date intelligence.
Monitoring updates
Our fair service policy includes any addition of a regulation, standard or guideline for free.
Product assignments
PREXEVUS let’s you assign the standards, regulations and guidelines to products, to portfolios, to sites or the entire company for a structured approach to the monitoring.
License Management
Each standard can be bought individually and there is no need to buy packages or collections. Never buy a standard twice because a team member doesn’t know about it.
Alerting
Alerting can be specified for each user and for it’s preferences, e.g. whether the user wants to get alerted daily, weekly, monthly, or quarterly.
Fulltext search
PREXEVUS let’s search any document in full text. With this, you don’t need to care which standard is applicable, you simply search for a term specific to your product.
Monitoring threats
Monitoring is structured in threats. Each monitored document, whether a standard, regulation or guideline, is defined as monitoring threat.