Hi Roberto,

In addition to the points some people mentioned above, I believe there are some additional benefits to keeping meeting minutes:

1. They offer legal protection.
2. They provide structure.
3. They drive action.
4. They act as a measuring stick.
5. They state ownership.

Source: http://www.allbusiness.com

In my R and D work experience, I worked a lot with new product development and just as our senior design projects, customer needs/design requirements and test plans are huge deliverables. Once the customer told us their needs (in my case a perfusionist), we were able to write the design requirements for a particular heart lung machine. We then had…[Read more]

I believe it is important to directly quote the FDA about design inputs (ISO 13485:2003)

Inputs relating to product requirements shall be determined and records maintained. These inputs shall include:
a) functional, performance, and safety requirements, according to the intended use,
b) applicable statutory and regulatory requirements,
c) where…[Read more]

I think the following is a great way to think of verification vs validation:

Validation: Are we building the right system?
Verification: Are we building the system right?

In other words, validation is concerned with checking that the system will meet the customer’s actual needs, while verification is concerned with whether the system is w…[Read more]

I think the following is a great way to think verification vs validation:

Validation: Are we building the right system?
Verification: Are we building the system right?

In other words, validation is concerned with checking that the system will meet the customer’s actual needs, while verification is concerned with whether the system is w…[Read more]

Design controls is a broad term that describes several procedures and processes used throughout the design and manufacture of a product, the basic focus of which are to ensure the most effective product design and that what is produced consistently reflects that design and the product’s intended use. Design inputs, outputs, review, change…[Read more]