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Computer.

Validation Documentation Matrix (Issue 6.)
$29.00
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-PQ Computer (Issue-4)
$159.00
10000003

Average rating:

It has been carefully designed to make it the preferred choice in all branches of the industry for the qualification of computers used in embedded / management / Control / Supervisory / Recording roles. It is a very popular 64 page document that can be swiftly and simply edited down for smaller systems or scaled up for larger systems.
The IQ section establishes documented verification that key aspects of the computer adhere to approved design intentions and that the recommendations of the regulators have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the computer performance in its normal operating environment is consistently as specified in the URS. Equipment Validation Protocol, validation protocol template,

Document Statistics

Protocols = 3

Pages = 64

Paragraphs = 1.09k

Lines = 3.03k

Words = 6.88k

Characters = 43.26k

Graphics = 36

Size = 625KB

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Computer Validation Master Plan (Issue 5.)
$115.00
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.

Document Statistics

Protocols = 1

Pages = 47

Paragraphs = 945

Lines = 1801

Words = 9922

Characters = 66311

Graphics = 15

Size = 789 KB

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CSV Validation Plan (Issue 3.)
$89.00
10000605

This document follows Validation Online's standard method of using a fully detailed and interactive generic document and enabling to use the attached SOP to quickly convert this generic document 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.

Document Statistics

Protocols = 1

Pages = 29

Paragraphs = 688

Lines = 1332

Words = 5571

Characters = 36210

Graphics = 12

Size = 303 KB

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Computer User Requirements Specification (Issue 5.)
$115.00
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
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.

Document Statistics

Protocols = 1

Pages = 29

Paragraphs = 634

Lines = 1961

Words = 3142

Characters = 19475

Graphics = 19

Size = 316 KB

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CSV Installation Qualification (Issue 6.)
$115.00
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.

Document Statistics

Protocols = 1

Pages = 51

Paragraphs = 1030

Lines = 3240

Words = 6006

Characters = 38541

Graphics = 39

Size = 581KB

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CSV Operational Qualification (Issue 6.)
$115.00
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.

Document Statistics

Protocols = 1

Pages = 40

Paragraphs = 664

Lines = 2291

Words = 4571

Characters = 28586

Graphics = 23

Size = 397 KB

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Software Validation SOP (Issue-2)
$22.00
10000700

This Standard Operating Procedure (SOP) takes you through the validation process for software, from the very early first stages to the final closing stage. It will ensure that your validation is seamless, that the correct documents are raised, approved, executed, reviewed and accepted correctly. It shows how to use validation tools such as the very important matrix control document and equally important software risk assessments. There are ever-increasing demands on the Biotechnology and Pharmaceutical industries to meet increasing regulatory and legislative requirements, whilst improving the performance and efficiency of the business. This SOP shows the way to streamline your validation while still being fully compliant. Easing and smoothing the production and flow of protocols, so decreasing costs and delivering validation ahead of schedule. It is essential material for the new comer to validation and will direct you flawlessly through all validation tasks. For the company it is an essential SOP to add to the library. For your convenience it is written in word.

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DCS Installation Qualification (Issue 6.)
$115.00
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.

Document Statistics

Protocols = 1

Pages = 51

Paragraphs = 1030

Lines = 3240

Words = 6006

Characters = 38541

Graphics = 39

Size = 581KB

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DCS Operational Qualification (Issue 5.)
$115.00
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.

Document Statistics

Protocols = 1

Pages = 40

Paragraphs = 664

Lines = 2291

Words = 4571

Characters = 28586

Graphics = 23

Size = 397 KB

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VrrP Computer iss-4
$298.00
12000021

This Validation, Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format. Resulting in the document becoming notably easier to use and quicker to review and amend. This new format will make a very significant difference to the man hours required to produce and execute these documents. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks. This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document. This is an essential step forward for companies seeking to reduce validation costs without sacrificing regulatory compliance.

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4Q Computer iss-4
$298.00
12000022

4Q Equipment Validation Protocol (4Q-Equip) has been designed specifically to replace four standard protocols. By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining validation documentation by reducing protocol numbers by close to 75%. The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now compliments our equally new VrrP Protocol. By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in the authoring, reviewing, updating and approving tasks. For everyone's convenience, it is still written in word.

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VrrP+4Q Computer Package
$499.00
12000023

Unlike our normal validation packages this quite revolutionary two document package is all that is required to fully validate; to cGMP standards, equipment used in a regulated facility. A lot of effort has gone into ensuring that repetitive instructions and actions have been designed out and innovative and intuitive risk-based methodologies have been incorporated. Both documents are prefaced with a methods' Standard Operating Practice (SOP) document. These SOP’s lead you through the task of converting these highly detailed templates into your very own company bespoke protocols. The hyperlinks and cross-references within the package are; not only unique but also highly cost-effective and intuitive to use. Each document is preloaded with the test scripts (complete with acceptance criteria). All test and inspection scripts are written in MS word, to facilitate simple editing of text, layout, tables and schematics.

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