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COMPUTER SECTION

All purchased documents are delivered automatically by electronic download. You will receive a download URL which is a continuous string of around 130 characters. It is extremely important that the string is not broken. Please check the string to ensure that your internet browser has not inserted a space, where it folds the link onto a new line. The links are limited in duration and number of operations.Delivery of your documents is guaranteed.  No matter what problems arise with Browser's, PC's or Network settings, we give all our customers an absolute cast iron guarantee that we will always find a way to ensure you receive; the documents you have purchased. .....If you find a fault on our site or any text that offends, please click on this green print and report it to us. We will take immediate action to remedy the problem and enter you into our free document draw.
Validation Documentation Matrix (Issue 4.)
$26.00 £15.60
10000002
This Matrix must sit along side your VMP or PVP and together with these documents give a very concise overall picture of your validation program. This four part matrix allows you to list all the equipment and systems that must be qualified. Each entry is allocated a row in the matrix. The row consists of eleven headings, these may be edited as required (but come with all the standard documentation titles inserted). In this matrix there is room to enter the document number, prefixed by, A to D. The document number gives you the instant cross reference to the current document, the A to D prefix shows the progress stage.
Please remember that this document is an Excel document, so when your download link arrives you must use Excel to open it


Quantity   
Combined_IQ-OQ_Issue-1
$125.00 £75.00
10000021

This Combined IQ – OQ protocol is a really easy and attractive document to use.  It is prefaced by a 10 page SOP, which enables you to follow the SOP instruction and progressively (page by page) convert this fully detailed template into a superb IQ/OQ protocol.

 

This protocol is targeted at equipment and is suitable for all equipment from the laboratory to the process line.  All standard verifications are already included in the protocol format with many more testscripts that can be edited in or out to tailor your IQ/OQ protocol exactly to your regulatory requirements.

Validation Online’s format of fully referenced, highly detailed interactive regulatory compliant documents has been extensively used by our customers in meeting their regulatory compliance needs throughout the world for ten years now.  Now this new combined IQ – OQ protocol brings a refreshingly simple and attractive approach for the industry professional to raise professional quality validation protocols in a most cost effective way.

  Now you too can raise a competent IQ / OQ combined protocol in matter of hours.


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Computer Validation Package 2. (Issue 3.)
$580.00 £348.00
10000590
The complete chain of regulatory required documentation for the validation of a computer system. This Validation Package contains one of each of these documents:
VP, URS, DQ, VRA, IQ, OQ, PQ.
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Computer Validation Master Plan (Issue 5.)
$89.00 £53.40
10000600
The Computer Validation Master Plan, is the starting point for validation, and hence the most important validation document. It improves validation efficiency greatly by forcing all concerned to document, review, and discuss, the proposed methods and allotted responsibilities. It is an expected document with the FDA, and a mandated document with the EU.
While in the past computer validation was more focused on functions of single user computer systems, recently the focus has progressed into network infrastructure, networked systems and on security, authenticity and integrity of data acquired and evaluated by computer systems.
However never forget that a piece of equipment is purchased and used, for a purpose, and that purpose is set out in the purchaser’s User Requirements Specification (URS). Therefore the first and foremost requirement for any piece of equipment, is the verification that it satisfies the requirements specified in this URS.

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CSV Validation Plan (Issue 3.)
$89.00 £53.40
10000605
This document follows Validation Online's standard method of using a generic document and allowing the customer to apply an attached detailed SOP to it, turning the generic document quickly into a first class company bespoke document. This CSV VP details and integrates all validation activities and procedures required for a small to medium sized project, involving production/facility/utility equipment using electronic controls or monitoring.
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Computer User Requirements Specification (Issue 5.)
$89.00 £53.40
10000620
The document that sets the standard, and specifies your computer requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of CURS, CURS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems that are the subject of predicate rules. It can be used on mechanical, electrical and software controlled, monitored or driven systems.

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CSV Design Qualification (Issue 3.)
$89.00 £53.40
10000622
The Standard Operating Procedure attached to this generic computer design qualification protocol, will chapter by chapter take you through the task of raising a fully detailed protocol. The main body is split into fourteen tables, each one probing the computer design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these computer design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that you’re DQ’s are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.


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CSV Installation Qualification (Issue 6.)
$89.00 £53.40
10000640
Installation Qualification (IQ) is an important step in the overall validation and qualification process for software and computer systems. Our protocol leads you through the detailed requirements. GAMP 4, is used as a general guide, however there are some areas where it is better to stick with the FDA interpretations. Validation Online has extensive validation experience, where we know that there is a regulatory sensitive area we make absolutely certain that our documentation is clear, concise and supplies the information the regulators are anticipating. These protocols have evolved over 15 years use in the pharmaceutical and allied industries.


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CSV Operational Qualification (Issue 6.)
$89.00 £53.40
10000680
Operational Qualification (OQ) is an important step in the overall validation and qualification process for software and computer systems. Our protocol leads you through the detailed requirements, progressively and simply. GAMP 4, is used as a general guide, however there are some areas where we find it preferable to stick with the FDA interpretations. Validation Online has extensive validation experience, where we have found over the years, on the regulatory debriefs, that there are certain presentations that they prefer, we have always been quick to comply. Just as with the IQ, this OQ has evolved over 15 years and countless regulatory reviews.


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Computer Performance Qualification (Issue 7.)
$87.00 £52.20
10000720
The Computer performance Qualification is the culmination of the validation process. The protocol is used in conjunction with the system operating SOP, to verify that the system process is consistent and correct. The results of the testing must be recorder and reviewed with a view to ensuring that the deviancies (within permitted tolerances) that exist are random and not a trend that will lead to out of specification operation during production use.

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DCS Installation Qualification (Issue 6.)
$85.00 £51.00
10000750
Installation Qualification of the DCS will confirm that; The title and version of the software is documented. The software has been loaded correctly. Specific site hardware items have been installed correctly. Power supplies, earth connections, and field connections are correct and enable the system to power up. Control and monitoring instrumentation are installed and have been calibrated. System functions operate on power up, and any built in diagnostics are satisfactory. Product contact material is acceptable. Drawing, documents, specification are all in place. 4.4 Electrical Conformance Verification (Minor). System Future Maintenance. Change & Consumable Parts.


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DCS Operational Qualification (Issue 5.)
$85.00 £51.00
10000760
DCS Operation Qualification.
Execution of the DCS Operational Qualification (OQ) will verify that; Radio Frequency Interference. Application Software Identification. 21 CFR Part 11 Conformance Verification. Equipment Function Test. Safety / Health / Environmental Assessments. Security of Back-up Software. Power failure Test. System Documentation (SOP Verification). Operating System Software. Test Equipment Calibration. 21 CFR Part 11 Eligibility Verification.


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21 CFR Part 11 Eligibility Verification (Issue 3.)
$16.00 £9.60
11000163
Test sheet used in the operational qualification protocol to document and record whether the equipment produces data that necessitates compliance with 21 CFR Part 11. This document is included in the standard OQ, but available separately here.

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21 CFR Part 11, Verification (Issue 3.)
$26.00 £15.60
11000164
This test script has been designed to verify whether a system or a specific piece of equipment conforms with the requirements detailed in Part11. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.

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Analog Address Verification (Issue 3.)
$16.00 £9.60
11000165
Analog Loop address verification. This confirms and documents that that the computer input specified in the system specification of the loop is correct. A mandatory part of system validation. This document is included in the standard IQ, but available separately here.


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Analog Loop Tests (Issue 3.)
$16.00 £9.60
11000166
Analog Loop testing. This confirms and documents the integrity of the entire loop, and is a mandatory part of validation of system. Only available here as a paste in addendum to the Installation Qualification.


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Application Software Identification Verification (Issue 2.)
$16.00 £9.60
11000167
Test sheet used in the operational qualification protocol to document and record the issue level, date of issue and title of the application software that the equipment under qualification has installed during execution of this operational qualification. This document is included in the standard OQ, but available separately here.


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System Drawing Verification (Issue 2.)
$16.00 £9.60
11000172
Test sheets used in Installation Qualification Protocol to verify that the engineering drawings are as required in 21 CFR. Comes with standard IQ, but available seperately here.


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Electrical Conformance Verification (minor) (Issue 3.)
$16.00 £9.60
11000173
Test sheets used in Installation Qualification Protocol to verify that the system electrical installation conforms to good industry standards. Comes with standard IQ, but available seperately here.


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Input Output Address Verification (Issue 3.)
$16.00 £9.60
11000176
Input output address verification is mandatory, and is executed to document and verify that the computer input output address configurations is in accordance with the drawing specifications. Only available here as a paste in addendum to the Installation Qualification.


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Power failure Test (Issue 3.)
$16.00 £9.60
11000180
Test sheet used in the operational qualification protocol to document and verify that when the equipment is subjected to an unintentional loss of electric supply it will fail and be reinstated in a manner save to the product and operating personnel. This document is included in the standard OQ, but available separately here.


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Operating System Software Verification (Issue 3.)
$16.00 £9.60
11000183
Test sheet used in operational qualification to document and record system operating software titles and issue level that were in used during OQ execution. Included in standard OQ, but available seperately here.
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Radio Frequency InterferenceVerification (Issue 5.)
$16.00 £9.60
11000185
Test sheet used in the operational qualification protocol to document and verify that when the operation of equipment will not be adversely affected by the use, near by, of radio emitting devices. This document is included in the standard OQ, but available separately here.


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Safety/Health/Environmental Assessments (Issue 2.)
$16.00 £9.60
11000187
There are several Health, Safety and Environmental assessments that must be carried before an item of equipment is put into service. This test script ensures that they are all in place and available for review. This document is not included in the standard operational qualification, but is a available here as a direct download.


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Security of Back-up Software (Issue 3.)
$16.00 £9.60
11000188
It is mandatory that where software has to be validated, there is a certified true copy, of that software stored in conditions laid down by cGMP's. This test script verifies that these conditions are being met. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.


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Sensor Calibration Verification (Issue 3.)
$16.00 £9.60
11000189
Test sheets used in Installation Qualification Protocol to verify that all system sensors requirements as detailed in 21 CFR, are complied with, comes with standard IQ, but available seperately here.


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Software Quality Verification (Issue 3.)
$16.00 £9.60
11000190
Test script used in operational qualification to document and record system operating software titles and issue level that were in used during OQ execution. Not Included in standard OQ, but available seperately here.


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System Component Verification (Issue 2.)
$16.00 £9.60
11000191
Test sheets used in Installation Qualification Protocol to verify that the system components are installed correctly and that the installation is documented as detailed in 21 CFR. Comes with standard IQ, but available seperately here.


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System Documentation (SOP) Verification (Issue 3.)
$16.00 £9.60
11000192
Test sheet used in operational qualification to verify that all the SOP requirements in CFR 21 for this type of equipment are in place and are approved company documents. Included in the standard OQ, but available separately here.


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System Documentation Verification (Issue 3.)
$16.00 £9.60
11000193
Test sheets used in Installation Qualification Protocol to verify that the equipment documentation is as required in 21 CFR. Comes with standard IQ, but available seperately here.


Quantity   
System Future Maintenance Verification (Issue 3.)
$16.00 £9.60
11000194
Test sheets used in Installation Qualification Protocol to verify that post qualifiction maintenance of system is adequate and complies with 21 CFR requirements. Comes with standard IQ, but available seperately here.


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Test Equipment Calibration Verification (Issue 6.)
$16.00 £9.60
11000195
Test sheet used in the operational qualification protocol to document and verify that all test equipment and sensors used in the execution of the operation qualification are calibrated, and have traceable calibration standards. This document is included in the standard OQ, but available separately here.


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Verification of Password Controlled Access (Issue 2.)
$16.00 £9.60
11000197
It is required to verify in this test script that access to the equipment is controlled by the use of passwords, and that the passwords are graded to allow access only for their authorized job functions. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.


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