How do regulations impact your product requirements? How do you ensure that you identify all the needed requirements changes to meet these regulations? Ideally, your regulations should live alongside your product requirements, so you can trace among each related item. Getting to that point can be quite an undertaking, however. Ultimately you want a process that: -Saves money -Ensures quality -Avoids fines If you want help achieving these goals, this webinar is for you. Watch Tom Totenberg, Senior Solutions Engineer for Helix ALM, show you: -How to import a regulation document into Helix ALM. -How to link to requirements. -How to automate impact analysis from regulatory updates.

1. Regulation Traceability
TOM TOTENBERG | SR. SOLUTIONS ENGINEER
Regulatory
Traceability
How to Maintain Compliance,
Quality, and Cost Efficiency
Tom Totenberg | Sr. Solutions Engineer

2. perforce.com
Agenda
1
2
3
What is Regulation Traceability?
Why should you care?
How to upload a regulatory document.
4 How to link regulations to requirements.
5 How to perform automatic impact analysis.

3. perforce.com
What is
regulation
traceability?

4. Regulations Requirements Tasks Tests

5. Why should
you care?
• Do you already have a system in place to
manage regulatory documents?
• How much time does it take to manage
those documents?
• How much time does it take to trace the
impact of regulation changes to your
product requirements?
• How much have you been fined for
regulatory noncompliance?
Would you like to be
automatically notified of which
requirements are likely impacted
by a change to a regulation?

6. Examples of
Regulations
by Industry
• FDA Regulated
• IEC 62304
• ISO 14971
• Automotive
• ISO 26262
• Aerospace
• DO-178C
• Financial
• Tax Codes
• All
• International country-specific regulations
(Labeling, hazardous materials, languages, etc.)

7. Demonstration
time!
Demonstration Time!

8. Questions?
Comments?
Hopes?
Dreams?