Inflectra | Fda

Posts Tagged 'Fda'

Configuring SpiraTeam for Testing in Validated Environments (Part 4)

At Inflectra we like to make the lives of customers easier and share knowledge. We have lots of customer in the life sciences industries using SpiraTeam to manage and test medical device systems and products. Since such products have to follow the FDA 21 CFR Part 11 requirements, we thought it would be useful to highlight some of the best practices we have for configuring SpiraTeam in such environments. This is the fourth article in the blog series, and covers the configuration of the release workflows.

(Read More)

validation healthcare medical devices cfr part 11 fda 21 CFR Part 11


Configuring SpiraTeam for Testing in Validated Environments (Part 3)

At Inflectra we like to make the lives of customers easier and share knowledge. We have lots of customer in the life sciences industries using SpiraTeam to manage and test medical device systems and products. Since such products have to follow the FDA 21 CFR Part 11 requirements, we thought it would be useful to highlight some of the best practices we have for configuring SpiraTeam in such environments. This is the third article in the blog series, and covers the configuration of the test case workflows.

(Read More)

validation healthcare medical devices cfr part 11 fda 21 CFR Part 11


Configuring SpiraTeam for Testing in Validated Environments (Part 2)

At Inflectra we like to make the lives of customers easier and share knowledge. We have lots of customers in the life sciences industries using SpiraTeam to manage and test medical device systems and products. Since such products have to follow the FDA 21 CFR Part 11 requirements, we thought it would be useful to highlight some of the best practices we have for configuring SpiraTeam in such environments. This is the second article in the blog series, and covers the configuration of the requirements workflows.

(Read More)

validation healthcare medical devices cfr part 11 fda 21 CFR Part 11


Configuring SpiraTeam for Testing in Validated Environments (Part 1)

At Inflectra we like to make the lives of customers easier and share knowledge. We have lots of customer in the life sciences industries using SpiraTeam to manage and test medical device systems and products. Since such products have to follow the FDA 21 CFR Part 11 requirements, we thought it would be useful to highlight some of the best practices we have for configuring SpiraTeam in such environments.

(Read More)

validation healthcare medical devices cfr part 11 fda 21 CFR Part 11


When the FDA Sheriff Comes to Town - You Need to be Ready!

In this morning's Washington Post, there was an article about 'The new sheriff in town' describing how the new biotechnology and drug screening startups in Silicon Valley are colliding with the conservative, formal testing philosophy of the United States Food & Drug Administration (FDA).

(Read More)

fda medical devices cfr part 11 hipaa


Spira 5.0 Preview - Digital Signatures

When developing software, systems and hardware for use in medical devices, healthcare IT systems or pharmaceutical processes, you need to follow a requirements and quality management process that complies with the FDA Title 21 CFR Part 11 set of Federal Regulations. Part 11 (as it's more commonly called) defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

(Read More)

digital signatures fda healthcare 21 CFR Part 11