Regulatory Expectations

Spreadsheet validation is an often neglected task and one that attracts the attention of all regulators, simply because they are pretty certain that they will find problems in the use, or design, or in the actual spreadsheet validation and or qualification.

The standard operating system used throughout industry for spreadsheet applications is Excel. Excel is a well used and known system with millions of programs in use word-wide. As such, it does not require to be validated. However applications that run on Excel do require to be validated. Just like any other software program the degree and scope of spreadsheet validation or qualification depends entirely on the risk or possibility that the application can affect product quality, efficacy or records.

Regulators expect you to be able to demonstrate that your spreadsheets are functioning correctly and consistently produce accurate data. If you cannot show with documented test evidence that this is the case, then your regulators or auditors can stop you using your spreadsheets or worse still stop your operations until the situation is resolved.

Validation Online offer a complete suite of spreadsheet validation documents, from the Validation Plan (VP) to the User Requirements Specification (URS) to the spreadsheet Validation Risk Assessment (VRA) and culminating in a combined Installation / Qualification / Performance Qualification (CSQ) protocol. These documents are newly and specifically designed not only to qualify your existing spreadsheets, but to ensure that all your future spreadsheet validation and qualification tasks are fully compliant.


Shocking News.

The importance and criticality of spreadsheets and spreadsheet validation, to the pharmaceutical industry was recently reported on. The report indicated that the results of a survey of twenty three professionals in this multi billion pound industry revealed some extraordinary and at times worrisome problems.
The interviewees said that spreadsheets were pervasive, and many were key and product critical. Further to this, there is almost no spreadsheet validation software quality assurance and people who create or modify spreadsheets are almost entirely self-taught. Two; each disclosed a recent instance where material spreadsheet error had led to adverse effects involving many tens of millions of pounds.

This spreadsheet validation or qualification images shows spreadsheet formats.

The Trials & Tribulations of Spreadsheet Validation.

In twenty years working within the regulatory compliance side of the drug and device industries, if I was asked to single out the single most abused process in use throughout these industries, I would have to nominate the design and use of spreadsheets. 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 stored 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 hard-copy, and Part 11 does not apply.

Having taken Part 11 out of the great debate; what remains. The same debaters might suggest that Excel will round up calculations, and has limitations as to its mathematical abilities. This also could be true. However it is very much up to the spreadsheet designer (and reviewer) to ensure that if number rounding is allowed; it does not meaningfully affect the accuracy of the spreadsheet calculations. Similarly the same persons must validate that the formula calculation is within the capabilities of the Excel software design.

SOP for Spreadsheet Creation. -- $125.00


Spreadsheet Validation Package. (Issue-1) -- $525.00


Out of Control Spreadsheets.

Spreadsheets and spreadsheet validation, are a potential source for the classical disaster. Companies run out of funding. Erroneous quality and efficacy statistics are produced and sometimes even stock levels are totally incorrect. On one audit, where the client stated they had four critical spreadsheets to be validated, their network was searched and 212 spreadsheets were found. One spreadsheet had 62 versions, all of which were active.

You must be ready for, and expect your regulator or auditor to review the quality, structure, scope, and spreadsheet validationEvaluate or qualification of your spreadsheets and review the following procedures and records.

  1. Create a spreadsheet inventory.
  2. Identify critical spreadsheets for review.
  3. Rank each spreadsheet's risk level.
  4. Develop a baseline for each spreadsheet
  5. Evaluate policies and procedures for spreadsheet use.
  6. Evaluate controls that protect spreadsheet integrity.
  7. Evaluate spreadsheet validation practices and procedures.

FDA Spreadsheet Comments.

  • Nearly all of the spreadsheets in the laboratory showed rounding-off errors and none used the Excel rounding function, when needed to avoid rounding-off discrepancies between the original and check calculations by the second analyst.
  • Formulas in the analytical procedures did not follow the Excel equations.
  • Conversion factors were not expressed in the analytical procedures.
  • The formulas used by the check analyst for manual calculations were not the same as those used in the Excel spreadsheet validation.
  • The pre-determined specifications or limits were not shown in the spreadsheets.
  • Spreadsheets were not clearly documented. For example, the product declaration was not indicated, replaced by only a number in a cell.
  • Units were expressed as numbers without descriptive labels such as mg/mL or mg/g.
  • Sample weights were described as sample volume and areas as ratios.
  • Spreadsheets did not contain provisions for security and integrity of data.
  • Spreadsheet applications were not protected from changes, meaning analysts could freely change labels and formulas.
  • Regression analysis was calculated with the y and x axis inverted in the Excel formula, which generated erroneous slope and intercept results.

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Equipment combined IQ/OQ/PQ Protocol.   $159.00

This combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedures. The associated Validation Master Plan is interactive, easy to use and suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that all validation Online executables are catered for and that key aspects of the equipment adhere to approved design intentions and the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating  consistently and exactly as specified in the URS.


Process Qualification (P2Q) (Issue 3.) -- $85.00

The Process Validation or Qualification is the culmination of the validation process. The protocol is used in conjunction with the SOP for the process, to run three batches through the process being qualified and verify that the process consistently produces product to within the process specified tolerances. The results of the process must be recorded and reviewed with a view to ensuring that the deviances (within permitted tolerances) that exist are random and not a trend that could lead to out of specification produce being produced.

12000002 VrrP Equipment $298.00

This Validation 4U, Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format.  This new format will make a significant difference to the man hours required to produce and execute these standard operating practice process validation master plan executables. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks.  This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document. 
This is an essential step forward for companies seeking to reduce validation 4U costs whilst remaining compliant with their Corporate Validation Manual.

12000006_4Q_Equip_iss-4. -- $298.00

4Q Equipment Validation 4U Protocol (4Q-Equip) has been designed specifically to replace four standard protocols.   By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining process validation  Online executables documentation and associated standard operating procedures, by reducing protocol numbers by close to 75%.  The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now compliments our equally new VrrP Protocol.  By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in the authoring, reviewing, updating and approving tasks.
For everyone's convenience, the Corporate Validation 4U Manual template is written in written in word.