Global safety database software

Software used in pharmacovigilance clinskill academy. Database management software for online database creation. Safety monitoring, expedited reporting, pharmacovigilance. Gensuite was founded on collaborating with ehs leaders to create practical solutions to address everyday business safety, environmental and sustainability challenges. Wolf, senior director of global clinical safety and. Argus and empirica software have been synonymous with drug safety database and pharmacovigilance software for the past 10 years. Who collects data and information both from national competent institutions and from faowho scientific committees. Offering safety data sheet solutions for organizations of every size, across all industries, we are widely recognized as an industryleading sds company for ensuring safety. Accessing safetydrugs database via saas avoids your company to invest. Our newly designed and rebuilt msdsonline sds chemical management platform combines more than 20 years of software innovation and industry best practices, making it easier than ever before to track, manage and report on hazardous chemicals and provide righttoknow access to safety data. Which are the most commonly used softwares in pharmacovigilance.

Ghsauth by markov computer systems is an easy to use software tool for authoring global harmonized standard ghs compliant safety data sheet sds documents and safety labels. Browz has provided contractor prequalification and contractor management solutions for the worlds leading organizations since 2001. It consists of reports of adverse reactions to medicines and vaccines received from member countries since 1968. Browz contractor management services, prequalification. Safety data management and global safety database oracle argus. With more than 1800 customers in 70 countries, our company is leading in the development of software for the creation and management of safety data.

Chemical safety software was tasked with implementing a rapid and costeffective solution to address this the needs of this organization, chemical safety matched the existing chemical inventories to its vast database of safety data sheets sds and its most uptodate ghs chemical reference database. In the pv world, this is the icsr database and the software that is used to. The pharmacovigilance database has been designed around the ich e2b. Argus safetys advanced database helps ensure global regulatory compliance, enables sound safety decisions and. The leader in safety management software industrysafe. Safety data sheets free sds database chemical safety. Pharmacovigilance pv softwaredrug safety databases an. According to a recent resolution of the world health assembly, who is facilitating the data access to experts and food safety professionals. Donesafe makes it fast and easy to access, enter and report ehs data in real time. When your team is in the field, they can access a full database of material safety data.

If you would like to have control over your safety data but do not want the cost and delay of setting up a compliant safety processing system, quanticate has an alternative. More than just a safety database software vendor, ab cube has been for 8 years an important partner in our regulatory compliance. Pvworks human pharmacovigilance software ennov software. Global safety management gsm ensures that your material safety data sheets now sdss are readily available, uptodate and easily accessible on computers, tablets, and mobile devices. Pvedge drug safety database for end to end pharmacovigilance. Global sds authoring center hosts educational webinars and provides training covering all aspects of safety data sheet sdsmsds preparation, update and management.

Amid the periodic evolutions and amendments in safety monitoring regulations, maintaining the safety data of medicinal productsdevices is the ultimate responsibility of marketing. Under new requirements for safety data sheets, now more than ever companies must provide access to accurate, uptodate environmental, health, and safety documents and labels, demonstrate ghs and ehs compliance with global. Global safety network is your source for complete employment screening and safety compliance services. Global safety database means the database containing adverse events, serious adverse events, serious adverse drug reactions and pregnancy reports for the combined therapy, and shall. Sdspro is a leading provider of sds and chemical management services and software that vastly simplifies the nuances of the osha haz com 2012 mandate. Company owned data include those captured in a clinical safety database or the. Vigibase is a whos global individual case safety report icsr database that contains icsrs submitted by the participating member states enrolled under. Vigibase is a whos global individual case safety report icsr database that. The quickest, most reliable and safest chemical safety management system. Sds library is an online library of safety data sheets.

Industrysafe safety management software helps organizations effectively manage their ehs program to improve workplace safety, osha compliance, and performance. We invite you to add your sds or msds sheets for free or to search our library as often as you wish. In order to create safety data sheets sdss for your products, you need to comply with regulations such as ghs which is the globally harmonized system of classification, labelling and packaging of substances and mixtures. Pharmacovigilance software e2b r3 drug safety database medical.

Vigibase tm is the name of the who global database of individual case safety reports icsrs. During 20142019, the global pharmacovigilance software. See why caspio is trusted by over 12,000 companies worldwide. Arisglobal is leading the way with an innovative pharmacovigilance software. In fact, lost time from injuries and illnesses cost 4% of the global gdp. The international hazard communication standard hcs mandates that chemical manufacturers must communicate a chemicals hazard information to chemical handlers by providing a safety data sheet. Softwares like argus, arisglobal, and pvnet are used in pharmacovigilance. It is the largest and most comprehensive database in the world, and is developed and maintained by the umc on behalf who and its member states. Air liquide sante international has decided to use safetyeasy md too, since we have. Pharmacovigilance services and risk management quanticate. Applications international corporation aic is the global leader in enterprisewide safety management systems, compliance management software, hr. We can set up and host your pharmacovigilance safety database and provide you with access to your data. Manage material safety data sheets sds with msdsonline.

Pharmacovigilance safety database argus safety database. Donesafe is health, safety and environment software that connects your management system from workers in the field to the management team in the boardroom. Saas safety drugs can be rented in saas software as a service procedure, and installed directly on an owned server. The software enables a highly scalable endtoend safety process providing automated global case processing, periodic reporting, e2b intake and submission, comprehensive reporting, detailed analytics, and japanese safety operations from within a single system. Cosmetovigilance software ab cube our safety database. Pvworks human is a flexible software system designed to support pv business. A safety database software allows the pharmacovigilance department to monitor, assess, and report to the regulatory authorities.

Occupational health and safety software solutions for. Gsn provides comprehensive workforce risk mitigation and management solutions, drug and alcohol testing, and training solutions. Oracle argus provides deep and integrated safety functionality out of the box that scales to millions of cases and easily aligns with your safety and business processes. Track required, completed or missed employee safety training easily and effectively. The international hazard communication standard hcs mandates that chemical manufacturers must communicate a chemicals hazard information to chemical handlers by providing a safety data. Pharmacovigilance and drug safety software platform. Our ehs enterprise management software enables you to solve complicated business challenges through intuitive data tracking, real time kpi metrics, and automated reporting. With patient safety as the critical component in product. Both systems 21 cfr part 11 fully compliant safety solutions. Primevigilance is equipped with fully supported safety database solutions for a compliant and effective pharmacovigilance system. Our safety and pharmacovigilance teams support clinical trial and postmarketing safety surveillance across the globe. Global regulations are harmonizing towards ich and pvedge drug safety database is compliant with those ich e2b r3 and gdpr regulations. Our msds management software is accessible on smartphones, tablets, and computers. Global safety database legal definition of global safety.

A global pharmacovigilance safety database sits at the heart of the vigilance system for medicinal products and devices. Drug safety platform lifesphere safety enhances core drug safety database. A safety data sheet, or sds, is a standardized document that contains occupational safety and health data. The drug safety database allows the riskbenefit analysis of medicinal products taking into account new and emerging. Dynamic homepage helps to meet regulatory compliance and maintain. Safety data sheets software sds management software. Arisglobal lifesphere safety multivigilance and argus oracle health sciences safety. The preferred safety system of 9 global regulatory authorities, including the us fda. Global database which fulfills drug safety requirements of multiple regions, viz.

Oracle argus is a fully validated e2b r3 compliant safety database, which enables quality and efficiency in handling safety data. Pharmacovigilance software is having its salesforce moment. Global safety management gsm ensures that your safety data sheets sdss are readily available, uptodate and easily accessible on computers, tablets, and mobile devices. Global head, pharmacovigilance eu qppv healthcare global. Open access to the who global pharmacovigilance data base. Safety data sheets sds australia chemical compliance. Database fujitsu software symfoware symfoware server is fujitsu s relational database management system, providing large capacity, high performance and high stability for. Calculate your roi by using calculations and safety multipliers based on actual results, benchmark studies, and industry data. Gsn provides comprehensive workforce risk mitigation and management solutions. Both systems 21 cfr part 11 fully compliant safety solutions which are an essential part of good pharmacovigilance practice. It is perfectly suitable to save sensitive data within the safety. Safety training data updates automatically in real time. Global safety database means the database containing adverse events, serious adverse events, serious adverse drug reactions and pregnancy reports for the combined therapy, and shall be the authoritative data source for regulatory reporting and responding to regulatory queries with respect to the combined therapy clinical trial.