02_Equipment at 009_VALIDATION ONLINE DOCUMENTATION SHOP

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Equipment.

Validation Master Plan (Issue 7)
$115.00
10000001

This document follows our proven practice of supplying a interactive generic document with an automatic method of populating it. Once populated, all you need to do is follow the prompts in the attached SOP. They will take you through the completion process section, by section. At the end of this process your generic document has progressed into a detailed, referenced, bespoke company document. The document follows our three level URS system that ensures functionality traceability from the URS to the various testing protocols. A great document to author and use. This document interfaces with our Validation Risk Assessment assessment (VRA), Validation Project Plan (VP), User Requirements Specification (URS), giving a seamless flow from your VMP through the VP - IQ - OQ - PQ, while integrating flawlessly with the URS - DQ - VRA.

Document Statistics

Protocols = 1

Pages = 47

Paragraphs = 945

Lines = 1801

Words = 9922

Characters = 66311

Graphics = 15

Size = 789 KB

Quantity

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 Equipment. (Issue-5)
$159.00
10000005

This three part document arrives with you fully detailed with all test scripts, rationales and test methods all laid out in accordance with regulatory expectations. As can be deduced from the document statistics figures below there are abundant tables to simplify presentation and enhance the protocol execution phase. The document was specifically designed to be compliant with the all of the FDA, EC and WHO legislation and guidance documentation and over 1700 have been used in submissions to regulatory authorities. This combined IQ/OQ/PQ protocol along with the appropriate interrelated plans and assessment documents will not only validate the item under qualification but it will also produce the thorough audit trail needed to meet all internal or external regulatory reviews and or inspections.

Document Statistics

Protocols = 3

Pages = 64

Paragraphs = 1.09k

Lines = 3.03k

Words = 6.88k

Characters = 43.26k

Graphics = 36

Size = 625KB

Quantity

Vendor Audit Document (Issue 4)
$89.00
10000007

This document should be customised using the find and replace word feature. The document can then be re-focussed to reflect your project priorities. The fifteen chapters all contain 10 questions, the total scored is then weighted to reflect your priorities. By assessing the importance of each of the chapter subjects in your project, the weighting is altered taking points from one and adding to others. For example in a recent audit, after weighting, order of priorities became; delivery number one, validation number two, and price trailing at number nine. The document has been used to audit major and minor manufacturing and support companies. It is a very searching audit tool, and completely removes the possibility of suggestions that personal biases and opinions influenced the final audit decision. When you audit with this document; they know they have been audited.

Validation Plan (Issue 8)
$89.00
10000008

This document follows our well developed 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 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

Quantity

User Requirements Specification (Issue 7.)
$115.00
10000010

The document that sets the standard, and specifies your 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 URS, URS 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.

Document Statistics

Protocols = 1

Pages = 27

Paragraphs = 481

Lines = 1374

Words = 2563

Characters = 18021

Graphics = 14

Size = 302 KB

Quantity

Design Qualification (Issue 4.)
$115.00
10000012

The Standard Operating Procedure attached to this generic design qualification protocol, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the 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 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

Quantity

Validation Risk Assessment (Issue11.)
$125.00
10000014

The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation 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 validation activities.
This VRA now includes the assessment table for categorising 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).

Document Statistics

Protocols = 1

Pages = 18

Paragraphs = 344

Lines = 810

Words = 341

Characters = 20084

Graphics = 10

Size = 179 KB

Quantity

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

The SOP used to generate this 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 Protocol. 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. There is now no reason for not being able to produce 4 to 8, IQ protocols per 8 hour day.

Document Statistics

Protocols = 1

Pages = 51

Paragraphs = 1030

Lines = 3240

Words = 6006

Characters = 38541

Graphics = 39

Size = 581KB

Quantity

Combined_IQ-OQ_Issue-2
$125.00
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.

Quantity

Operational Qualification, SOP & Protocol (Issue 10.)
$115.00
10000025

You will find the step by step attached SOP 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 Operational Qualification Protocol. 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.

Document Statistics

Protocols = 1

Pages = 40

Paragraphs = 664

Lines = 2291

Words = 4571

Characters = 28586

Graphics = 23

Size = 397 KB

Quantity

Performance Qualification (P1Q) (Issue 5.)
$89.00
10000027

The Performance Qualification is the last of the qualifying tests that equipment and processes are subjected to, prior to the actual first product run. It maybe that there are some steps in the process that can only be verified by actually running them (quick freezing and sublimation, to mention only two) or it somtimes is the fact that the product is a very expensive product, and can not be wasted. So no one wants to run the process with product, until they are completely certain there will be minimal waste.

Document Statistics

Protocols = 1

Pages = 21

Paragraphs = 219

Lines = 982

Words = 2532

Characters = 13840

Graphics = 8

Size = 204KB

Quantity

Process Qualification (P2Q) (Issue 3.)
$85.00
10000028

The Process Qualification is the culmination of the validation process. The protocol is used in conjunction with the SOP for the process, to run three batches through the process being qualified and verify that the process consistently produces product to within the process specified tolerances. The results of the process 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 produce being produced.

Document Statistics

Protocols = 1

Pages = 21

Paragraphs = 321

Lines = 984

Words = 2597

Characters = 13978

Graphics = 9

Size = 204KB

Quantity

Package Equipment Validation Level-1. (Issue 3)
$360.00
10000101
Level One.
You want to validate a relatively minor, new or replacement piece of equipment that is going to be used within a facility that is fully validated and subject to change control.
In this case you require the following validation protocols;
DQ, IQ, OQ, PQ.
Level 1 Package consists of one of each of these documents.

Document Statistics

Protocols = 4

Pages = 141

Paragraphs = 2649

Lines = 8476

Words = 18316

Characters = 100580

Graphics = 135

Size = 2867KB

Quantity

Package Equipment Validation Level-2. (Issue 3)
$585.00
10000102
Level Two.
You want to validate a process line or new process equipment or equipment that has been subjected to major modification.
In this case you require the following validation protocols :-
VP, URS, VRA, DQ, IQ, OQ, PQ.
Level 2 Package consists of one of each of these.

Document Statistics

Protocols = 7

Pages = 215

Paragraphs = 4060

Lines = 12000

Words = 24726

Characters = 184757

Graphics = 125

Size = 2755KB

Quantity

Package Equipment Validation Level-3. (Issue 4)
$695.00
10000103
Level Three.
You have a new installation or refurbished installation or piece of equipment and you want to establish the correct validation documentation.
In this case you require the following validation protocols:-
VMP, VP, URS, VRA, DQ, IQ, OQ, PQ.
Level 3 Package consists of one of each of these documents.)

Document Statistics

Protocols = 8

Pages = 262

Paragraphs = 5005

Lines = 13794

Words = 34658

Characters = 241068

Graphics = 140

Size = 3096KB

Quantity

10000149_PQ_Steam (Issue 2.)
$115.00
10000149

Steam Quality Validation. This a high quality protocol listing all component parts that required for setting up and executing of the three main steam quality tests. All the operator has to do is use the auto fill function to personalize the PQ, then follow through the detailed test methods recording the results as they go.
A continuous supply of saturated steam is required for steam sterilization. Too high a level of non condensable gases will prevent the attainment of sterilization; too little moisture carried in suspension may allow the steam to become superheated during expansion into the chamber, while excess moisture may cause damp loads. Where steam systems are either routinely or irregularly shut down, large quantities of air will be present in the distribution system on restarting. It is recommended that in such circumstances a comprehensive and validated venting procedure should be applied, and testing of steam quality is mandatory.

Quantity