Guide for Pharmaceutical Manufacturing Industry Research & Development Medical Pharmacy Students FDA updates Guidelines
Custom Search
Showing posts with label Pharma software validation. Show all posts
Showing posts with label Pharma software validation. Show all posts

Thursday, June 16, 2011

Pharma Software Development System Design

Pharma System Design and Software Development
The decision to implement system functionality using software is one that is typically made during system  design. Software requirements are typically derived from the overall system requirements and design for
those aspects in the system that are to be implemented using software. There are user needs and intended uses for a finished device, but users typically do not specify whether those requirements are to be met by hardware, software, or some combination of both. Therefore, software validation must be considered within the context of the overall design validation for the system.

A documented requirements specification represents the user's needs and intended uses from which the product is developed. A primary goal of software validation is to then demonstrate that all completed
software products comply with all documented Pharma software and system requirements. The correctness and completeness of both the system requirements and the software requirements should be addressed as part of the design validation process for the device. Software validation includes confirmation of conformance to all software specifications and confirmation that all software requirements are traceable to the system  specifications. Confirmation is an important part of the overall design validation to ensure that all aspects of the medical device conform to user needs and intended uses.
good manufacturing practices
Also see

Current good manufacturing guidelines

21 CFR Part 11 Requirements

Medical Device 510(k) Clearances

Software validation Regulatory Requirements

Benefits of software validation in medical devices and pharmaceuticals

Pharmaceutical Educational Website Autored by B V WAGHMARE

Pharmaceutical Educational Website Autored by B V WAGHMARE

Like This Website on Facebook and Stay Connected Share This Article with your Friends

Latest Pharma Update

USFDA approves first drug Inmazeb to treat Ebola Virus Infection

US FDA approved first drug to treat Ebola Virus Infection (zaire ebolavirus) . So far there was no drug treatment available for Ebola virus ...

You May Also Like

If you are looking for latest Pharmaceutical Manufacturing Guidelines of USFDA, UKMHRA, TGA WHO GMP then this website is one of most popular source.
Subscribe to this website by providing your email

Enter your email address get latest Pharma Guideline and technology update by email whenever this website is updated