*Spreadsheet + Critical Data = Mandatory Validation*
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.
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.
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
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:
Validation Risk Assessment template (Issue 11) $125.00 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 risk assessment 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).
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 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
This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the User requirements specification template through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems and compliance with Current Good Manufacturing Practice legislation. It can be used on mechanical, electrical and software controlled, monitored or driven systems and of course medical device validatioN Template along with the Software Qualification template.
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.
You will find the 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.