KEEP FOCUSED
Make Certain You Receive Our Free Monthly Newsletter.
By Entering Your E-mail Address In This Box.


Enter Your First Name or Your Preferred Title.
In This Box.

Then

Don't worry -- your e-mail address is totally secure.
I promise to use it only to send you FDA COMPLIANT.

Home
21 CFR Part 11
Calibration
cGMP's
GMP / FDA / 483 /
Computer Validation
CSV ANNEX 11
Computer Vendor Audit
Conditions of Use
Contact Us Directly.
Contracted Validate
Calculators For All
Corporate Gifts
Data Loggers
Design Qualification
Document Shop
Facility Qualification
Fridge Guard
Gap Analysis Tool
Wealth Maker
Your Free Glossary
HACCP
HVAC Qualification
Installation Qualify
Operation Qualify
Part 11 Update
Customer List
Performance Qualify
Glossary
Predicate Rules
Process Qualification
Retro-Validation
Product for License
GAMP 4 / 5
SOP for SOP
SOP for cGMP Rev
Steam Quality
Product for License
Temp. Mapping
User Requirements
Introduction.
Validation Matrix
Validation Enquiry
Val. Master Plans
Validation Blog
Free Newsletter
Video News
Validation Packages
Validation Plans.
Protocol Standards
Risk Assessment
Free Vendor Audit
Vender Audit.
Warning Letters

GAMP 4 SOFTWARE CATEGORIES.

INTRODUCING THE - GAMP 4 - ....................OR CLICK HERE FOR OUR MESSAGE BOARD....................OR CLICK HERE FOR OUR JOB CENTRE....................OR CLICK HERE FOR THE LATEST ON TEMPERATURE MAPPING & LOGGING...................OR CLICK HERE TO GO STRAIGHT TO OUR DOCUMENT STORE.

GAMP 4 SCOPE

GAMP 4, Introduction. Due to the great variety of medical devices, processes, and manufacturing facilities, it is not possible to state in one document all of the specific validation elements that are applicable. However, a general application of several broad concepts can be used successfully as guidance for validation. These broad concepts provide an acceptable framework for building a comprehensive approach to software validation.


GAMP Class
Category

Validation Action

1

Operating systems

Record Version

2
Instruments and controllers

Record configeration and calibration

3
Configerable packages

Audit supplier validate any bespoke code. Apply full life-cycle requirements.



4
Systems that the code or part of the code are configurable.
Audit supplier and code, validate any bespoke configurations apply full life cycle requirements.

5
Systems utilizing custom or bespoke code which develope predicate rules information.


Audit supplier, validate all code, apply full life-cycle requirements.

The Guide for Validation of Automated Systems, has been released in December 2001 in Amsterdam. The guide aims to assist companies in the healthcare industries to achieve validated and compliant automated systems.

It provides guidance to the suppliers of those automated systems on their development and maintenance by following good practice, and assists the suppliers in producing the necessary documentation required to support validation.

The guide is a significant advance on previous versions of this widely accepted guidance on validation of automated systems. The complete document has been revisited and refined to reflect current regulatory expectations and good practice. It has been considerably enhanced and restructured, following principles and recommendations defined by the Industry Board>
To order please visit:

GAMP 4


footer for GAMP 4 page