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LAN Qualification.

LAN validation mainly consists of a process of establishing appropriately documented verifications and tests that provide a high level of assurance that a computer system will operate in accordance with predefined specifications. The specific approach to be used for each level of qualification should be outlined in the project validation plan and needs to focus on the critical parameters, data, and functionality of the computer system. While there are no absolute lines to be drawn between qualification testing of a computer system, it is recognized that the qualifications listed below provide the necessary control and continuity throughout the validation life cycle and must be approved for the system to be released for use in the GMP environment.

a)                         Design Qualification.

b)                         Installation Qualification.

c)                         Operational Qualification.

d)                         Performance Qualification.


Local Area Network.

A Local Area Network is required to operate a server centric environment where devices (PCs etc.) positioned throughout a site buildings can connect to servers that provide specific services (print services, file services etc.). To facilitate this environment they must include one or more Gigabit routing switches which are configured in a fault tolerant configuration, providing automatic routing switch fail-over (hot redundant standby through industry standard Virtual Router Redundancy Protocol or Standby Routing Protocol). The system implements “Hot-swappable” chassis modules, allowing I.T. personnel to swap any failed module without interruption to the network.

These Gigabit switches form the core network backbone.

The backbone in turn has departmental edge switches connected into the overall backbone and again a fault tolerant configuration is implemented on the majority of these systems to enable LAN Validation..

LAN Validation Key Objectives.

1)                  Ensure that I.T. operate as a valued strategic asset to the company.

2)                  Implementation of a quality and reliable LAN Backbone.

3)                  Maintain full compatibility with installed base of IEEE 802.3 E nodes.

4)                  Implementation of IEEE 802.3z (Gigabit Ethernet) for LAN Backbone.

5)                  Support and implementation of IEEE 802.1D Spanning Tree Protocol.

6)                  Implement monitoring tools to establish key quality LAN metrics.

7)                  High availability.

8)                  High level of security.

9)                  Scalability. Capability of aggregating future bandwidth growth.

10)               IP Traffic Prioritisation.

11)               Backbone routing.

12)               Fault-tolerant backbone.

13)               100 Mbps switched to the desktop.

14)               n) Standardization on one networking technology


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Validation Risk Assessment (Issue 11) $125.00

Risk Mitigation in Validation template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation online train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your Risk Mitigation in Validation template.

This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).

Combined IQ-OQ-PQ Computer (Issue-4) $159.00

This Pharmaceutical Validation combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedure TEMPLATE. The associated medical device validation  Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a Risk Mitigation in Validation risk Assessment template. As per 21 CFR Part 11.

The Installation Qualification Template or IQ section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; The User Requirements Specification template 

Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this installation Qualification template (IQ), takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification template. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for current Good Manufacturing Practice use medical device use or a simple installation qualification template. 

Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find this validation online intuitive Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation  Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol, along with the installation qualification template.