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Regulatory-Changes

Regulatory Requirements Change Management

With constant regulatory changes globally, keeping track of these and staying on top is a real challenge. In addition to this the volume of data growing poses additional burden on Regulatory teams.

Regulation/Law Alerts

  • Vistaar’s subject experts review final guidance or regulations and alert you on changes that matter to you in the countries you prefer
  • Reduce noise by opting only for specific functional/business areas in certain countries based on your product life cycle or your business function
  • See exactly what’s new in the modified text with our change-tracking feature and quickly identify the requirements that apply in one clean, easy process

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Guidance Monitoring

  • Subscribe to global Guidance (both Draft and Final)
  • Share with anyone in the company. In addition, if you prefer add your comments or your content and disperse as a document.
  • Tag/Bookmark to ensure monthly guidance report generated for either Tracking or internal Compliance reasons

Regulatory Changes and Versions

  • Know exactly what changed in the regulation and view by concise text prepared by Vistaar Regulatory analysts
  • You’ll receive a brief 2 or 3 line summary of changes (via email or in system)  to decide on taking any subsequent actions or disregard them

Regulatory Impact Assessment

Upon receiving any new or change alerts, your initial consideration may be, “How does this affect my products, markets or work?”

  • Vistaar provides impact assessment module to guide through full life cycle process – from task assessment to country-specific user involvement, local assessments, impact outcomes and subsequent steps, all integrated into linked project/tasks.
  • If product information is available, product change impact assessments can also be conducted.

Your Benefits with Change Management

  • Cut down Noise of too many alerts
  • Know when important changes for you to act swiftly
  • Ensure product compliance by staying on top of changes proactively
  • Save Time from manual comparison when new guidance/regulation documents are released

For more information about Regulatory Change Management & Impact Assessment