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Track and Manage your Regulatory Activities | ViSU

Still depending on Excels sheets, registration trackers, ERP software to manage your global regulatory Health authority or notified body compliance activities. As a result, many teams end up using such software (or Excels) to manage their regulatory activities and thereby putting companies, products and ultimately patients at risk. Choose DDi’s Regulatory Information Management tool - ViSU to eliminate the compliance risks.

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Track and Manage your Regulatory Activities | ViSU

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  1. WWW.DDISMART.COM TRACK AND MANAGE YOUR REGULATORY ACTIVITIES REGULATORY INFORMATION MANAGEMENT | VISU

  2. RIM Tool byVISU HOW ARE YOU MANAGING YOUR MEDICAL DEVICES REGULATORY INFORMATION / REGISTRATIONS / COMMITMENTS & COMPLIANCE? WWW.DDISMART.COM

  3. 1. INACCURATE REGULATORYINFORMATION: 4 RISKS IN RELYING ON THESE TOOLS/SOFTWARE TO TRACK & MANAGE YOUR REGULATORYACTIVITIES As these are all general-purpose tools, itisvery hard to gather all regulatory informationina structured manner within a stipulatedtime.This often leads to incomplete information which leads to either overlook by teams or extra efforts to gather information from differentsources. W W W . D D I S M A R T . C O M

  4. 4 RISKS IN RELYING ON THESE TOOLS/SOFTWARE TO TRACK & MANAGE YOUR REGULATORYACTIVITIES 2. IMPROPER REQUIREMENTS & EXTERNALTEAMS ACCESS: Trackers created using Excel usually arestoredon the author’s computer and are notaccessibleby other teams (locally& globally)inreal-time. This makes it harder to share, validate,andtrack changes – frequently leading to incorrect requirements which may cause delays in regulatory submissions or answering notified bodyfindings. W W W . D D I S M A R T . C O M

  5. 3. COMPLIANCERISKS: 4 RISKS IN RELYING ON THESE TOOLS/SOFTWARE TO TRACK & MANAGE YOUR REGULATORYACTIVITIES Most importantly – it is very easyforregulatory information to fall through the crackswhenusing Excel/PLM/ERP to manage them.Evencritical information can be lost when the resourcewhois handling these sheets forget to update, or getsreassignedtootherprojects,orleavesanorganization. W W W . D D I S M A R T . C O M

  6. 4. TECHNOLOGYBURDEN: 4 RISKS IN RELYING ON THESE TOOLS/SOFTWARE TO TRACK & MANAGE YOUR REGULATORYACTIVITIES If companies create their ownin-house systems for this,the tightly coupledintegrationsand the complexity that comes with itmakesthe upgrades very challenging when the business requirements change. With cloudbased3rd party tools, this risk is greatlymitigated. W W W . D D I S M A R T . C O M

  7. THANKYOU Read fullArticle Visitus Subscribe ourBLOG W W W . D D I S M A R T . C O M

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