Journal of Validation TechnologyCharlie Neal, Jr.
sample was not initially collected. Cooperation isessential and critical. Therefore, each member mustbe focused on the overall tasks, and willing to coop-erate 100%.
In reality, it does not matter how much knowl-edge, experience, and understanding a firm has, if they don’t allocate the proper resources for conduct-ing effective validations. What do we mean by re-sources? By resources, we of course mean personnelwho will plan and execute, equipment on which val-idations will be performed on, materials, with whichto conduct validations, laboratories that will performnecessary analyses, funding to payfor the validations, and TIME inwhich to perform validations. Val-idations can often begin, but cannotbe completed if any one of these re-sources are missing.As an example, consider an auto-clave on which a new load configu-ration requires validation. Awindow
has been created by the equipmentowner (time, equipment), the owner’sdepartment has provided all the human resourcesrequired (personnel), and the lab is ready for samples(laboratories). However, the validation team hasbeen advised that the laboratory does not have the re-quiredspore strips (materials) in inventory. Can val-
idation be completed? No, since spore strips arerequired in order to assess the efficacy of the cycle.The same holds true for any resource required forvalidation.
It is important to understand that a successful val-idation must be done to completion. Typically, it
should not be limited by a budget assembled by per-sonnel who have no appreciation for what is requiredto successfully complete validation. Further, it is im-portant to understand that validations cost money. Arule of thumb has been that equipment qualifications,which are integral parts of validations, are typically10-20% of the cost of the capital equipment. Where
do these charges come from? Typically, these charges
are related to the time to execute the following costinitiatives:
• Investigate/acquire information• Conduct meetings• Plan• Put the plan into words (protocol)• Execute the plan•Troubleshoot and/or resolve problems• Summarize the effortConsider how projects are funded within corpo-rations. Each department has to prepare an annualbudget for anticipated expenses. It is very importantthat the anticipated costs are shared with upper man-agement to assure that ample support-or funding-exists. Now consider validation and the bulletedactivities listed above. From a corporate standpoint,each one of these elements require time, and there-fore have an associated cost.Thus, it is essential that they are reflected in thevalidation budget.
Aprofessional sports team cannot be expected towin the championship without a plan. Most of theseteams refer to their plans as plays. Without plays, agood offensive football team cannot hope for suc-cess against another good team’s defense. For exam-ple, if the quarterback does not know where hisreceivers will be, how often would he be able tocomplete a pass? If a running back did not know histeam’s blocking strategy, how many yards would heaverage per play? Per game? Per year?Bear in mind, that conducting validations withinmost companies will involve a number of depart-ments and disciplines. These disciplines need a planin order to get good team synergy. Further, this planmust be communicated in order to be accepted andsuccessful.
So often,the wait for the receiptof analytical results causes theentire validation project to cometo a halt.Why? Becausevalidations are based uponthe results obtained.