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*Spreadsheet + Critical Data = Mandatory Validation*

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 this spreadsheet validation 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 validation 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 validation 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 or validation of your spreadsheets and review the following procedures and records for evidence of:

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

 Synopsis of Regulatory Displeasure.

  • Nearly all of the validation 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.
  • Spreadsheet validations 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 validation 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.

Validation Risk Assessment (Issue 11) $125.00

Risk Mitigation in Validation template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation online 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 Risk Mitigation in Validation template.

This VRA now includes the assessment table for categorizing 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).

Combined IQ-OQ-PQ Computer (Issue-4) $159.00

This Pharmaceutical Validation 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 procedure TEMPLATE. The associated medical device validation  Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a Risk Mitigation in Validation risk Assessment template. As per 21 CFR Part 11.

The Installation Qualification Template or IQ section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A 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 medical device validation template; The User Requirements Specification template 

Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this installation Qualification template (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 template. 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, whether for current Good Manufacturing Practice use medical device use or a simple installation qualification template. 

Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find this validation online intuitive Operational Qualification template (OQ) 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 21 CFR Part 11 compliant Installation  Qualification Template. 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, along with the installation qualification template.

User Requirements Specification Template

The User Requirements Specification template is the document that sets the standard, and specifies your requirements in a manner that ensures when a system or piece of equipment is selected for cGMP use that all essential support elements; i.e. maintenance, parts, operator & maintenance training, are planned and budgeted for.  It uses three levels of User Requirements Specification Template (URS), URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final OQ and PQ functionality testing. A requirement mandated by cGMP regulations. It can be used on mechanical, electrical and software controlled, monitored or driven systems. 

Corporate Validation Manual $1,160.00

This definitive 1000 + page (including all attachments) Corporate Validation Manual arrives with you in USB memory stick format, this enables you at any time to download protocol or test-scrips documents and quickly edit them into company bespoke documents. In fact there are over $3,500.00 worth of superb documents, that form attachments to the DVM manual, which can be instantly copied. Once copied, the unique document interactive editing, allows you to produce high quality bespoke company documents; Such as the Validation Plan Template or the equally ubiquitous User requirements Specification template Design Qualification (DQ); in a few hours. The cost of the Definitive Validation Manual, will be recouped in the first few weeks of use. It will then go on to show a massive return on your original investment.