In 2011 this blog was listed as one of the top 10 blog in pharma technical information it is popular amongst the pharmacists and pharma industry professionals. We have published very important and very useful information for pharma industry professionals.

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

No comments:


What is 21 CFR Part 11, US FDA guidelines requirements of FDA compliance and CFR 21 Part 11.

What is a Site Master file of a pharmaceutical company

What is Generic Drug

What is Reference Listed Drug  ? ( RLD )

What is Pharmaceutical Equivalents

What is Pharmaceutical Alternatives

What is Therapeutic Equivalents

What are Post Market studies

Why a drug is bound to protein, What is protein binding?  What is drug absorption , distribution ?

Do Physical properties contribute to drug activity.

What is drug receptor , How a drug resistance occurs

Mechanism of drug resistance

What is drug interaction

Drug interaction, and its examples

What is first pass metabolism of a drug

What is What is 510(k) Clearances ?

What is 510(k) Clearances,

Premarket Notification for medical devices - PMN or 510(k)

What is a drug interaction

Examples of drug interactions


Antibiotic Definition and classification


Antibiotic Resistance and Antibiotic resistance mechanism

Antioxidants food supplements

Vitamin D Details on FDA cautions on accurate dosage of Vitamin D


What is an antibody? what is monoclonal and polyclonal antibodies?

Terminologies In vaccine Production

Multi stage testing of Virus vaccine production

Testing of vaccines at different stages of production

TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION

Enzyme linked immunosorbent assay ELISA

Raido Immuno assay

http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.

http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in

pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing


Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coefficient of a disinfectant

Sterility testing

Clean Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Requirements of US FDA Inspections of Clinical Investigators of Clinical Trials

PROCEDURE OF AN INSPECTIONS OF CLINICAL TRIAL INVESTIGATOR BY US FDA HOW ARE CLINICAL INVESTIGATOR INSPECTIONS CONDUCTED?

US FDA INSPECTION OF CLINICAL INVESTIGATORS OUT OF UNITED STATES OF AMERICA

REPORTS AFTER AN INSPECTION OF A INVESTIGAOTR OF CLINICAL TRIALS

Controlling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detailed information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs

BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Electronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates