Iatkos validating package contents
HVAC New System Qualification Package This package is targeted at the new build where the original design concepts are translated into a URS.From which the full flow of qualification documentation can be generated, and correctly cross referenced. You have a new facility and you want to validate it. Why does something as simple as a spreadsheet figure in so many regulatory citations?Inspectors expect to see a complete suite of validation documents in place for each validation task.The use and scope of the individual documents has been documented, discussed and explained in detail.This post will describe how to enable a right-click option on any content in the Monitoring tab of the admin console.You can download the file and follow the directions in the included ‘info.txt’ file for a fast deployment to your admin console. First you must create the proper r-click context menu.Config Mgr 2012 has a feature that allows you to validate content of a distribution point on a schedule, which works great for normal business.However, if you encounter an issue on a package and need to validate content immediately for each DP, it does require a bit of effort, as you have to go to the object in question, view the properties, then on the Content Locations tab, select a DP and click “Validate” – rinse and repeat–you must do this for each DP to validate content, as described in the documentation.
We use the Get-WMIobject (gwmi) cmdlet for the SMS_Distribution Point class, filtered to only receive DPs for the desired Package ID.
After numerous requests 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.
Next, copy the Power Shell code below, and save it to C:\Power Shell\CM12RClick Tools\Validate Package.ps1 (although it’s named Validate Package, it does work for all content–Application, OS Image, Package, etc).
[code language=”powershell”] #capturing arguments: $Site Server = $args $Site Namespace = $args $Site Code = ($args).
After due diligence is used to review the current Good Manufacturing Practice (c GMP) legislation (21 CFR Part 11/210/211/820) along with the FDA guidance documents (not mandatory but probably advisable) it becomes rather obvious why there is cascade of documentation and why each document in this cascade is obligatory.