Risk Management with TFS 2015

Is it possible to implement a fully functional risk management system in TFS 2015? Yes it certainly is and in the following post I will show you how. Continue reading

Neil Moffatt

Passionate about everything ALM and agile process/tools adoption into regulated organizations (FDA). Specializing in medical device companies.

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Requirements Traceability with TFS 2013

One of the key reasons to adopt an ALM solution such as TFS 2013 is to be able to standardize business processes and maintain project data in a single repository to facilitate information sharing. Continue reading

Neil Moffatt

Passionate about everything ALM and agile process/tools adoption into regulated organizations (FDA). Specializing in medical device companies.

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Design Control Process (21 CFR Part 820) in TFS 2013

Implementing a design control process is a very resource intensive project. In addition to defining the process add into the mix adopting new technology to support the process. Now the project may seem to be overwhelming but it does not have to be! Continue reading

Neil Moffatt

Passionate about everything ALM and agile process/tools adoption into regulated organizations (FDA). Specializing in medical device companies.

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Validation Strategy – Introducing TFS 2013 into FDA environments

We are asked the question all the time about how to execute the validation process to allow for the use of TFS into the production environment. When working with the regulatory departments of our clients we find that the effort involved for the validation project is too high. Continue reading

Neil Moffatt

Passionate about everything ALM and agile process/tools adoption into regulated organizations (FDA). Specializing in medical device companies.

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Electronic Signature Compliance (21 CFR Part 11) with TFS 2013

Microsoft Team Foundation Server (TFS) 2013 is rapidly growing as a leader in the Application Lifecycle Management (ALM) domain. More and more we are finding that regulated organizations are inquiring on how to adopt TFS as an enterprise ALM solution. In the following post I will explore the topic of how TFS implements electronic signature functionality and satisfies Title 21 of the Code of Federal Regulations Part 11 (21 CFR Part 11 or 21CFR11) requirements.  Continue reading

Neil Moffatt

Passionate about everything ALM and agile process/tools adoption into regulated organizations (FDA). Specializing in medical device companies.

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Follow Me:
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