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Machinery Validation.

Machinery Validation IQ (Issue-2)
$69.00
10000780

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

Machinery Validation OQ (Issue-2)
$69.00
10000785

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

Machinery Validation VP (Issue-2)
$98.00
10000771

This Machinery validation plan follows our well established 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

Machinery Validation VRA (Issue-2)
$125.00
10000774

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

Machinery Validation DQ (Issue-2)
$69.00
10000775

The prefaced SOP takes you through the task of raising a fully detailed and FDA compliant document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. This interactive document will lead you through all these design aspects. It is an easy document to use and will ensure that the bespoke DQ you produce will be adequately scoped, fully detailed, up to date and unambiguous to execute. Practically all the requirements are in presented in editable tables. You just edit these tables to produce your quality DQ document.

Document Statistics

Protocols = 1

Pages = 29

Paragraphs = 634

Lines = 1961

Words = 3142

Characters = 19475

Graphics = 19

Size = 316 KB

Quantity

Machinery Validation URS (Issue2)
$69.00
10000773

This is 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 must but is not limited to, mandating requirements for maintenance procedures, establishing calibration records, documenting all operational tasks, security of all records and enabling 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.

Quantity

Machinery Validation PQ (Issue-2)
$69.00
10000786

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

Machinery Validation Pack Level 3 (Issue-2).
$199.00
10000788
Level Three.

One of our Validation Packages. Procurement of a new machine center or a substantial refurbished of an existing installation or just a an existing system that you want to establish the correct validation documentation stream for.
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