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 TEMPLATE. 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 online documentation sales.

Available - COMBINED IQ/OQ/PQ:     Available - LIMS Protocols and Packages:;     Available - DENTAL VALIDATION DOCUMENTATION:     Available - AUTOCLAVE VALIDATION:     Want our - MONTHLY NEWSLETTER:     Free - VALIDATION DOCUMENTS:



Validation Packages.

Package Spreadsheet Validation. (Issue 1)
$525.00
10000026
Spreadsheet problems are by far the most common problems encountered during regulatory inspections of analytical laboratories and pharmaceutical facilities. The QC laboratories often failed to follow current good manufacturing practice (cGMP) and good laboratory practice (GLP) regulations. Also, basic principles of multi-user spreadsheet design, validation and documentation are not always used. This renders the spreadsheets un-validatable and leaves the company and the individual technicians extremely vulnerable. This document package has been carefully designed and developed to ensure that the spreadsheets you develop; using it, will be validatable.

Spreadsheet Package contains.
URS, VP, DQ, VRA and Combined IQ/OQ/PQ.

Document Statistics

 Protocols = 5

Pages = 185 

Paragraphs = 3544      

Lines = 7631 

Words =  6006 

 Characters = 28045

 Graphics = 87

 Size = 2155KB


Quantity   
Package for Equipment Validation Level-1. (Issue 3)
$465.00
10000101
Level One.
You want to execute the minimum paperwork to qualify an item. Start with a VP because it is mandatory. Raise a URS because it also is mandatory. Raise a VRA because it is mandatory in risk based validation. Execute all tests and inspections using a combination IQ-OQ-PQ. This is a balance approach and covers the mandated regulatory requirements. To be used within a facility that is fully validated and subject to change control.
Just to recap in this case you require the following validation protocols;
VP, URS, VRA, 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 for Equipment Validation Level-2. (Issue 3)
$585.00
10000102
Level Two.
You want to validate a process line or new process equipment or individual process assembly stage equipment or just similar equipment that has 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 for 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   
Package Clean Room Validation. (Issue 4)
$265.00
10000153
The important selection of validation document for validation of Clean Rooms or Zones. This Validation Package contains one of each of these documents:
IQ, OQ & PQ.
Quantity   
10000301_Stability_Cabinet_ValidationPackage_Issue-3
$585.00
10000301
This document follows our own standard practice of using a fully detailed generic document with an interactive SOP integral to it. Executing the SOP evolves the generic document quickly into a first class company cGMP compliant bespoke document. This VP must document all methodologies, boundaries and responsibilities, along with defining validation limitation and scopes. It is a master reference for all validation variables and queries.

This package contains:- VP, URS, VRA, DQ, IQ, OQ and PQ.
Quantity   
Cold Chain Validation Package level-1
$587.00
10000396

The contents of this package is the six documents that make up the advertised document package.
THERE ARE NO DATA LOGGERS IN THIS PURCHASE.
The Validation Plan (VP) must detail what you are going to do, who is going to do it, when, how and where they are going to do it. The User Requirements Specification (URS) must document exactly what the end user wants this equipment to do. The Design Qualification (DQ) will verify the design. Validation Risk Assessment (VRA) will define the depth of validation required and document the justification; a requirement mandated in CFR's. After this, the standard flow of documents is required - Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). This is now the simplest, most expedient and most cost effective method of validating the climatic condition within any mobile container or vehicle body. Each of these documents is mandated by cGMP's. There are no compliant short cuts.
VP, URS, DQ, VRA, IQ, OQ, PQ. - - This package consists of one of each of these documents, but no data loggers.


Quantity   
Cold Chain Validation Package Level-2
$1,699.00
10000397

This package is suitable for rooms or cabinets up to 10 cubic meters and arrives complete with all the validation documentation you require to validate the temperature condition within a warehouse a room or a large cabinet. Documentation includes our interactive and detailed Validation Plan (VP), The equally well detailed User Requirement Specification (URS), the Validation Risk Assessment (VRA). The Design Qualification (DQ) along with the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are ten, temperature easy to use data loggers ready to monitor and record close to 17K (each channel) parameters over what ever time base you select. This is now the simplest most expedient and most cost effective method of validating the climatic condition within any climatically controlled zone.

Contains:- VP, URS, DQ, VRA, IQ, OQ & PQ.
10 off Temperature Data Loggers (Capacity 18k parameters). This is sufficient coverage to qualify a small vehicle with a temperature controlled volume of 1 to 2 cubic meters. Compatible with a 10 foot Reefer or container

.
Quantity   
Cold Chain Validation Package Level-3
$2,654.00
10000398

This package is suitable for rooms or cabinets up to 50 cubic meters and arrives complete with all the validation documentation you require to validate the climatic condition within a warehouse, room or a cabinet. Documentation includes our interactive and detailed Validation Plan (VP), the equally well detailed User Requirements Specification (URS), the Validation Risk Assessment (VRA) and the Design Qualification (DQ) along with the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are twenty temperature data loggers ready to monitor and record close to 17K (each channel) parameters over what ever time base you select.
Contains:- VP, URS, DQ, VRA, IQ, OQ & PQ.
20 off Temperature Data Loggers (Capacity 17k parameters). This is sufficient coverage to qualify a small vehicle with a temperature controlled volume of 5 to 25 cubic meters. Compatible with a 20 foot Reefer or container


.
Quantity   
Cold Chain Validation Package Level-4
$4,064.00
10000399

The contents of this package includes quantity 30 off, single channel data loggers. Simple and robust to use; their use renders the whole validation task - much simpler. There needs to be a User Requirements Specification (URS) that will document exactly what the end user wants. The Design Qualification DQ will verify that the design is compliant with URS. This needs a Validation Risk Assessment (VRA) to define the depth of validation required and to document this decision; as is mandated in CFR's. After this, the standard flow of documents is required - Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). All these documents are fully detailed and are designed to be simple and expedient for the end-user to follow.
This is now the simplest, most expedient and most cost effective method of validating the climatic condition within any mobile container or vehicle body. VP, URS, DQ, VRA, IQ, OQ, PQ. - This package consists of one of each of these documents. Plus 30 off single channel temperature data loggers. This is sufficient coverage to qualify a small vehicle with a temperature controlled volume of 20 to 60 cubic meters. Compatible with a 40 foot Reefer or container

.
Quantity   
Package Climatic Zone Validation. Level-4 (Issue 3)
$475.00
10000424
If your requirement is to validate a cold / hot climate controlled cabinet or room that is used within a facility that is fully validated and subject to change control and you do not need to purchase temperature and humidity recorders, then this package comes without hardware.
In this case you only require the following validation protocols;
VP, VRA, IQ, OQ, PQ.
This package consists of one of each of these documents.

Quantity   
LIMS Validation Package. (Issue-2)
$585.00
10000510
A much used sequence of interrelated, cross referenced and sequential FDA mandated documents. The ideal package for the busy laboratory technician to follow. Simplicity personified; a Validation Plan (VP) to set out scopes, responsibilities, time lines and methodologies, in a clear simple way that will not only please your regulators but will ensure compliance. A well designed User Requirements Specification (URS) to detail the functionality of the equipment under qualification and to maintain the traceability of all verifications. A Design Qualification (DQ) that will ensure that your individual laboratory equipment’s design is adequate to execute their allotted tasks. A Validation Risk Assessment (VRA) to ensure your validation scope is set in line with the regulatory requirements for this class of equipment. Finally the redoubtable fully detailed and interactive Installation (IQ), Operational (OQ) and Performance Qualification (PQ) Protocols.
Package includes:- VP, URS, DQ, VRA, IQ, OQ, PQ.
Quantity   
Enterprise Resource Planning (ERP) Validation Package.
$675.00
10000550
An ERP system that is not validated will not pass a regulatory inspection. The Sunshine Act requires manufacturers of pharmaceutical drugs and devices, as well as group purchasing organizations, to report payments or transfers of value (such as meals, honoraria, or travel reimbursements) made to U.S. physicians and teaching hospitals. The law also requires manufacturers and GPOs to report physicians who have an ownership interest in the company. Reports are made to the Centers for Medicare and Medicaid Services (CMS), a government agency. This ERP validation package contains the complete range of validation documents to ensure seamless continuity to your validation task. It contains one of each of the following documents.
VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.

Document Statistics

 Protocols = 8

Pages = 225 

Paragraphs = 41.96k    

Lines = 11.3k 

Words = 29.59k 

 Characters = 192.8k

 Graphics = 130

 Size = 2291KB


Quantity   
Package for Computer Validation Level-1. (Issue 1)
$675.00
10000580
This computer validation package contains the complete range of validation documents to ensure seamless continuity to your validation task. It contains one of each of the following documents. VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.

Document Statistics

 Protocols = 8

Pages = 225 

Paragraphs = 41.96k    

Lines = 11.3k 

Words = 29.59k 

 Characters = 192.8k

 Graphics = 130

 Size = 2291KB


Quantity   
Package Computer Validation Level-2. (Issue 3)
$610.00
10000590
In this chain of regulatory required validation documentation for the validation of a computer system, the VMP has been omitted. This package is targeted at any system that does not required a dedicated VMP to be raised. The Validation Package contains one of each of these documents:
VP, URS, DQ, VRA, IQ, OQ, PQ.
Quantity   
Package Software Validation. (Issue 1)
$699.00
10000770
This software validation package starts with an SOP detailing the validation task and also includes individual SOP's for the completion of most of the documents. Continuous information from URS to PQ. Documents included are: VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.
Quantity   
Package Laboratory Validation. (Issue 1)
$577.00
10000801
Here is the ideal package for the busy laboratory manager. A Validation Plan (VP) to set out scopes, responsibilities, time lines and methodologies, in a clear simple way that will not only please your regulators but will ensure compliance. A well designed User Requirements Specification (URS) to detail the functionality of the equipment under qualification and to maintain the traceability of all verifications. A Design Qualification (DQ) that will ensure that your individual laboratory equipment’s design is adequate to execute their allotted tasks. A Validation Risk Assessment (VRA) to ensure your validation scope is set at the appropriate level for the equipment being qualified and the redoubtable fully detailed and interactive Combined Installation, Operational and Performance Qualification Protocol (IQ/OQ/PQ); specifically developed by Validation Online for laboratory equipment with or without embedded software.
Package includes:- VP, URS, DQ, VRA, Combined IQ/OQ/PQ.
Quantity   
Package HVAC Validation Level-1. (Issue 5)
$499.00
10001040
You have a major component change or major modification to validate; This Validation Package contains one of each of these documents:
VP, URS, DQ IQ, OQ, PQ.
Quantity   
Package HVAC Validation Level-2, (Issue 3)
$675.00
10001050
This package is targeted at the new build where the original design concepts are translated into a URS. From which the full flow of qualification documentation can be generated, and correctly cross referenced. This Validation Package contains one of each of these documents:
VMP, VP, URS, VRA, DQ, IQ, OQ, PQ.
Quantity   
Package Utility Validation. (Issue 2)
$675.00
10001060
This utility validation package contains: VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.
Quantity   
Package Facility Validation. (Issue 2)
$675.00
10001070
This facility validation package contains: VMP, VP, URS, VRA, DQ, IQ, OQ and PQ. VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.

Document Statistics

 Protocols = 8

Pages = 225 

Paragraphs = 41.96k    

Lines = 11.3k 

Words = 29.59k 

 Characters = 192.8k

 Graphics = 130

 Size = 2291KB


Quantity   
Package PLC Validation Iss-2
$610.00
10001080
The Validation Plan (VP) must detail what you are going to do, who is going to do it, when, how and where they are going to do it. The User Requirements Specification (URS) must document exactly what the end user wants this equipment to do. The Design Qualification (DQ) will verify the design. Validation Risk Assessment (VRA) will define the depth of validation required and document the justification; a requirement mandated in CFR's. After this, the standard flow of documents is required - Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). This is now the simplest, most expedient and most cost effective method of validating the climatic condition within any mobile container or vehicle body. Each of these documents is mandated by cGMP's. There are no compliant short cuts. VP, URS, DQ, VRA, IQ, OQ, PQ. - - This package consists of one of each of these documents.
Quantity   
Package Water System Validation. (Issue 1)
$675.00
10001090
It is required that all pharmaceutical pure water systems are subjected to sufficient tests and inspections to verify and document that the system is installed, operating, and performing as per the user requirements, prior to production handover. Validation documentation is made up of the following components:
This Validation Package contains: VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.
Quantity   
Package Distriburtion System Validation. (Issue 2)
$675.00
10001100
This Distrubution System Validaion (DCS) package contains: VMP, VP, URS, VRA, DQ, IQ, OQ and PA.
Quantity   
Package Network Validation. (Issue 6)
$680.00
10001115
The complete chain of regulatory required documentation for the validation of an IT Network system. This Validation Package does not contain the VMP as network qualification will usually be included in the the master VMP or a VMP dedicated to computer controlled equipment and or systems. This package contains one of each of these documents:
VP, URS, DQ, VRA, IQ, OQ, PQ.
Quantity   
Package Autoclave Validation. (Issue 2)
$675.00
10001115

This package of documents is ideal for those who are in the procurement stage for one or more new or refurbished autoclaves. Follow the Validation plan (VP) and use it to ensure all eventualities in the procurement process are identified and planned for. Ensure resources are allocated for all minor and major support tasks. Use the DQ to verify that this design of autoclave is capable of fulfilling all your functional, GMP and safety requirements. If all your autoclaves are the same then one VP, DQ and URS may be all that is required. Then it is quite simple to copy over individual IQ, OQ and PQ protocols from the document package; which on execution will verify that all the requirements as documented in the URS have been fully satisfied.

This autoclave validation package contains: VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.
Quantity   

Package Building Management System (BMS) Validation. (Issue 2)
$675.00
10001120
This Building Management System (BMS) package of templates simplifies your task of authoring all the required documents to qualify a BMS system. With these interactive fully detailed documents the hard work is practically all completed for you. The final product is a professional and comprehensive Building Management System (BMS) suite of documents, already for execution. This Building Management System validation package contains the full range of interactive validation documents and protocols:

VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.
Quantity   
10002025_Dental_Validation_Package
$695.00
10002025
Dental_Validation_Package (VRA).
The validation package takes the strain out of validation. Just follow the guiding SOP's; that are integral to each protocol, through to completion, then sign off the protocols and start the protocol execution stage. Using the package guarantees that you will not run into discrepancies late in your execution program (this is the cause of the majority of validation delays).
This package contains:-
VMP, VP, URS, VRA, DQ & IQ/OQ/PQ Protocol. As an introductory offer it also contains free of charge: SOP Equipment Validation, DMR, DHF & DHR Forms.
Quantity   
10003000_MD_Package_issue-3
$838.00
10003000
Medical Device_Validation_Package (VRA).
The validation package takes the strain out of validation. Just follow the guiding SOP's; that are integral to each protocol, through to completion, then sign off the protocols and start the protocol execution stage. Using the package guarantees that you will not run into discrepancies late in your execution program (this is the cause of the majority of validation delays).
This package contains:-
VMP, VP, URS, VRA, DQ, IQ, OQ, PQ, Matrix, DMR, DHF & DHR, Documents.
This is the most comprehensive validation package offered for sale anywhere.
Quantity   
Click here to view
CUSTOMER APPRAISALS.