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



Spreadsheet Protocols.

Spreadsheet Matrix. (Issue-2)
$29.00
10000004
This matrix gives a clear and concise overview of all spreadsheets in company use. It indicates the current validation documentation status and the individual spreadsheet issue levels. This matrix is a regulatory required document.

Quantity   
Validation Plan for Spreadsheets. (Issue-1)
$89.00
10000009
A validation plan is a very important document that states what is to be done, the scope of approach, the schedule of validation activities, the tasks to be performed, and who is responsible for performing each activity.
The plan must be reviewed and approved by management and accepted as company policy that will be used in the development and execution of the spreadsheet validation task. It will define and allocate responsibilities for the; Purpose and scope of plan; background information; references; system overview and process description; vendor selection and management (when applicable) of development and implementation methodology.

Document Statistics

 Protocols = 1

Pages = 29 

Paragraphs = 688        

Lines = 1332 

Words =  5571 

 Characters = 36210

 Graphics = 12

 Size = 303 KB


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URS for Spreadsheets. (Issue-2).
$115.00
10000011
Currently, spreadsheets for analytical applications are widely used in the regulated industries; especially in microbiology laboratories and pharmaceutical production facilities. For these reasons it is highly desirable to standardize your spreadsheet design, on a design that is validatable. Our User Requirements Specification (URS) document is prefaced by an SOP; which will lead you through document completion. You will build a document that not delivers the testing traceability that the regulators expect from a URS, but is designed to be validated.

Document Statistics

 Protocols = 1

Pages = 27 

Paragraphs = 481         

Lines = 1374 

Words =  2563 

 Characters = 18021

 Graphics = 14

 Size = 302 KB


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VRA for Spreadsheets.
$125.00
10000015
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 = 3440       

Lines = 810 

Words =  3110 

 Characters = 20080

 Graphics = 10

 Size = 179KB


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DQ for Spreadsheets. (Issue-1)
$89.00
10000017
Design Qualification (DQ) protocol for a spreadsheet is one of the most important protocols in the validation chain of documents. A properly constructed DQ protocol will detail an organized approach for evaluating the design. It is a systematic way to verify that the user requirements as detailed in the URS will be met in full by the proposed design specification. It is essential that this verification is carried out using a company approved protocol. No commitment to proceed to purchase or develop the spreadsheet should be taken until the DQ has been executed. This DQ is an fully detailed and referenced interactive generic template which you will find simple and swift to edit into your own company specific Design Qualification.

Document Statistics

 Protocols = 1

Pages = 29 

Paragraphs = 634        

Lines = 1961 

Words =  3142 

 Characters = 19475

 Graphics = 19

 Size = 316 KB


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Combined IQ/OQ/PQ for Spreadsheets. (issue-2)
$159.00
10000022
This combination protocol has been specifically designed to verify that all aspects of your spreadsheet conform to best practice and that the spreadsheet layout ensures consistent and accurate use and results. The tests and inspections normally authored in separate protocols have been assembled in one protocol which is divided into three sections. This protocol enables you to verify that your developed spreadsheet application is GMP compliant, thus avoiding 483s and warning letters. You can now validate your application with minimal documentation.

Document Statistics

 Protocols = 3

Pages = 64 

Paragraphs = 1.09k   

Lines = 3.03k 

Words = 6.88k 

 Characters = 43.26k

 Graphics = 36

 Size = 625KB


Quantity   
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


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SOP for Spreadsheet Creation.
$125.00
10000125
Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11. If the spreadsheet is signed off by the user, their supervisor and QA, it becomes acceptable data stored in hard-copy, and Part 11 does not apply.

Quantity   
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