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.

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

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Size = 303 KB

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

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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).
Quantity   

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

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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 has three sections. This protocol enables you to verify that your developed spreadsheet application is GxP 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

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Size = 625KB

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 or apparent. 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.

Document Statistics

Protocols = 5

Pages = 185

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Words =  6006

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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 and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.

After numerous request for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.