Too many sources to follow
Updates may appear across FDA and other selected regulators, standards bodies, accreditation organizations, notified authorities and market-surveillance sources.
RegWatch for Quality and Regulatory Affairs Leaders
Connect product regulatory change with the quality system.
Monitor selected product, manufacturing, testing, quality-system, certification, labeling, reporting, recall and market-access requirements. RegWatch helps quality and regulatory teams organize changes by product, facility, jurisdiction and process owner.
No credit card required for the free monitoring account.
Regulatory change command center
Quality SystemsManufacturingTestingCertificationLabelingAdverse ReportingRecallsMarket Access
Why RegWatch
Product requirements change across the full lifecycle.
Quality and regulatory affairs teams must translate new rules and guidance into design, manufacturing, testing, labeling, reporting and post-market processes.
Cross-functional impact
Changes can affect quality systems, design controls, manufacturing, testing, labeling, reporting, supplier controls and post-market action at the same time.
Policies and processes can drift
Teams need a repeatable way to connect selected requirements with quality-system, manufacturing, testing, labeling, complaint, reporting and recall procedures.
Alerts need context and ownership
Reviewers need the source, dates, affected topics, responsible owners and a documented next step.
Monitoring Coverage
Build a watchlist around quality & regulatory affairs responsibilities.
Select the sources, jurisdictions and topics that matter to your organization. Expand or refine coverage as responsibilities change.
Quality systems and manufacturing
FDA QMSR, selected CGMP requirements, quality standards and inspection expectations.
Design, testing and validation
Product development, verification, validation, laboratory and performance requirements.
Certification and market access
Registrations, submissions, certifications, approvals and jurisdiction-specific market requirements.
Labeling and product information
Label content, instructions, claims, warnings, unique identifiers and promotional requirements.
Reporting and post-market surveillance
Adverse event, vigilance, complaint, periodic reporting and field-action requirements.
Recalls and corrective action
Recall, correction, removal, CAPA, supplier quality and regulatory communication developments.
Monitor availability and applicability vary by source, jurisdiction and organization. Your team chooses the watchlist it wants RegWatch to follow.
How RegWatch Works
Move from “something changed” to a focused review process.
Select your monitors, receive organized change intelligence and optionally connect policies for assessment.
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1
Select your monitors
Choose the agencies, regulations, standards, guidance sources and jurisdictions relevant to your responsibilities.
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2
Review focused change summaries
See what changed, important dates, affected requirements, source links and suggested review areas.
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3
Connect policies when useful
Upload and assign quality-system, manufacturing, testing, labeling, complaint, reporting and recall procedures to the monitors they support.
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4
Assess gaps and document action
Review potential policy gaps, ownership, next steps, remediation activity and supporting evidence.
Illustrative workflow
New Update
A selected source changes. Your team sees the context.
1
Monitor
Selected source
Actively monitoring
RegWatch follows the rule, bulletin, manual, guidance or licensing source your team selects.
2
Detect
Change identified
Change Alert Detected
Quality & Regulatory Affairs Update
New
+
Requirement updated
Source captured and compared with the previous version.
The update is captured, summarized and organized so reviewers can focus on what changed.
3
Review
Context delivered
RegWatch Review
Ready for your team
Ready
SummaryWhat changed
Key datesWhen it matters
PoliciesWhat to review
Next stepsWho owns action
Assigned to quality & regulatory affairs and cross-functional reviewers
Your team receives a focused review package instead of another unstructured alert.
Built for Quality & Regulatory Affairs Teams
Monitoring organized by product, market and quality process.
Build watchlists around product families, facilities, intended markets, certifications and lifecycle processes.
Create your free monitoring accountQuality assurance leadershipRegulatory affairs teamsManufacturing qualityProduct compliance and safetySupplier quality managementPost-market surveillance and vigilance
What Your Team Gains
A more manageable way to stay aware, assess impact and document follow-through.
Current quality criteria
Identify selected changes that may affect procedures, specifications and quality records.
Focused market reviews
Connect regulatory developments with products, labels, submissions and certifications.
Coordinated quality ownership
Route changes to regulatory, quality, engineering, manufacturing and supplier teams.
Traceable implementation
Preserve assessments, change controls, approvals and supporting regulatory evidence.
Frequently Asked Questions
Quality & Regulatory Affairs monitoring, with source context and ownership.
Start with selected monitoring sources, then add policy assessment workflows when useful.
Talk to AllgressCan teams monitor requirements by product and market?
Yes. Watchlists can be organized around selected product families, manufacturing sites, quality processes, certifications and jurisdictions. Available coverage depends on the monitors and sources selected.
Can we use RegWatch without uploading policies?
Yes. Regulatory monitoring and change review can be used without policy uploads. Uploading and assigning policies is optional and enables policy assessment workflows.
Can we organize monitoring by jurisdiction, business unit or responsibility?
Yes. Teams can build watchlists around the jurisdictions, entities, locations, products, services and responsibilities that matter to the organization.
How does policy assessment work?
Teams may upload and assign quality-system, manufacturing, testing, labeling, complaint, reporting and recall procedures to selected monitors. When a source changes, RegWatch can identify areas that may require review, clarification or remediation.
Does RegWatch determine legal applicability or replace professional advice?
No. RegWatch provides regulatory intelligence and workflow support. Your organization remains responsible for selecting sources, determining applicability and obtaining legal or professional advice where needed.
Start with the sources that matter to you
Make quality & regulatory affairs regulatory monitoring easier to manage.
Create a free RegWatch account and begin building the watchlist your organization wants to follow.