logo-shop-red-border-1.jpg

ALL DOCUMENTS ARE WRITTEN USING MS WORD OR EXCEL. THEY CARRY NO ADVERTS AND ARE 100% EDITABLE. TO SEARCH AND FIND A DOCUMENT TEMPLATE - FIRST SELECT THE APPROPRIATE SECTION FROM THE LIST BELOW - ONCE IN THAT SECTION - CLICK "Control f". THIS WILL OPEN A TEXT BOX AT THE BOTTOM LEFT OF THIS SCREEN. TYPE INTO THIS BOX - DOCUMENT TITLE OR PART OF IT, AND CLICK ON "Next" THIS WILL FIND TITLE AND STEP YOU THROUGH SIMILAR TITLES. WHEN YOU PURCHASE A DOCUMENT FROM THIS SITE YOU WILL AUTOMATICALLY BE SENT A URL LINK TO DOWNLOAD YOUR DOCUMENT. THESE URL LINKS ARE AROUND 130 CHARACTERS LONG AND IT IS ESSENTIAL THEY ARE NOT BROKEN.
Validation Online; is part of the AKC group which has over fifty years experience of QA & QC Implementation tasks and ten years of direct internet documentation sales.

Available - COMBINED IQ/OQ/PQ:     Available - LIMS Protocols and Packages:     Available - DENTAL VALIDATION DOCUMENTATION:     Available - AUTOCLAVE VALIDATION:     Get our - MONTHLY NEWSLETTER:     Free - Validation Documents:



Machinery Validation.

Machinery Validation DQ (Issue-2)
$115.00
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 IQ (Issue-2)
$115.00
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)
$115.00
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 PQ (Issue-2)
$98.00
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).
$695.00
10000788
Level Three.
You have a new installation or substantial refurbished of an 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   
Machinery Validation URS (Issue2)
$115.00
10000773
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   
Machinery Validation VP (Issue-2)
$98.00
10000771
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   
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   
Click here to view
CUSTOMER APPRAISALS.