How to prepare SRS and FS documents for a GxP critic processes

Hello,
We are a pharma company and we want to seperate SRS and FS documents whose processes are GxP critic or non-GxP.
Are there any standards to follow or samples? How should each document be prepared?
I would greatly appreciate any advice.
Thank you.
Altin

Hi Ali_Sampras ,
1. For a POC you might want to go for Evaluation [ option 0 ].
2. Execute ./vda-install ,reboot your server .
Once the server is up , execute ./vda-config and select option 0
You will have an evaluation setup up and running.
3.
-> You can use option 1/2 for a production setup ,high availability/fail over purpose i.e if you have 3 or more servers.
-> option 3 when you have license to use InnodB engine and have only one server.[here before executing ./vda-config you need to install/configure Innodb on the VDI host] .
-> option 0 when you have a single server and don't require fail over .
HTH ,
Udaya

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Hello,
Last, here is the script I used to reset permissions on the "My Documents" tree structure that admins did not have access to:
Example: Powershell script to parse a directory of User-owned "My Document" redirection folders and reset permissions.
#Script to Reset MyDocuments Folder permissions
$domainName = ([ADSI]'').name
Import-Module "PSCX" -ErrorAction Stop
Set-Privilege (new-object Pscx.Interop.TokenPrivilege "SeRestorePrivilege", $true) #Necessary to set Owner Permissions
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Set-Privilege (new-object Pscx.Interop.TokenPrivilege "SeTakeOwnershipPrivilege", $true) #Necessary to override FilePermissions & take Ownership
$Directorypath = "F:\Userpath" #locked user folders exist under here
$LockedDirs = Get-ChildItem $Directorypath -force #get all of the locked directories.
Foreach ($Locked in $LockedDirs) {
Write-Host "Resetting Permissions for "$Locked.Fullname
#######Take Ownership of the root directory
$blankdirAcl = New-Object System.Security.AccessControl.DirectorySecurity
$blankdirAcl.SetOwner([System.Security.Principal.NTAccount]'BUILTIN\Administrators')
$Locked.SetAccessControl($blankdirAcl)
###################### Setup & apply correct folder permissions to the root user folder
#Using recommendation from Ned Pyle's Ask Directory Services blog:
#Automatic creation of user folders for home, roaming profile and redirected folders.
$inherit = [system.security.accesscontrol.InheritanceFlags]"ContainerInherit, ObjectInherit"
$propagation = [system.security.accesscontrol.PropagationFlags]"None"
$fullrights = [System.Security.AccessControl.FileSystemRights]"FullControl"
$allowrights = [System.Security.AccessControl.AccessControlType]"Allow"
$DirACL = New-Object System.Security.AccessControl.DirectorySecurity
#Administrators: Full Control
$DirACL.AddAccessRule((new-object System.Security.AccessControl.FileSystemAccessRule("BUILTIN\Administrators",$fullrights, $inherit, $propagation, "Allow")))
#System: Full Control
$DirACL.AddAccessRule((new-object System.Security.AccessControl.FileSystemAccessRule("NT AUTHORITY\SYSTEM",$fullrights, $inherit, $propagation, "Allow")))
#Creator Owner: Full Control
$DirACL.AddAccessRule((new-object System.Security.AccessControl.FileSystemAccessRule("CREATOR OWNER",$fullrights, $inherit, $propagation, "Allow")))
#Useraccount: Full Control (ideally I would error check the existance of the user account in AD)
#$DirACL.AddAccessRule((new-object System.Security.AccessControl.FileSystemAccessRule("$domainName\$Locked.name",$fullrights, $inherit, $propagation, "Allow")))
$DirACL.AddAccessRule((new-object System.Security.AccessControl.FileSystemAccessRule("$domainName\$Locked",$fullrights, $inherit, $propagation, "Allow")))
#Remove Inheritance from the root user folder
$DirACL.SetAccessRuleProtection($True, $False) #SetAccessRuleProtection(block inheritance?, copy parent ACLs?)
#Set permissions on User Directory
Set-Acl -aclObject $DirACL -path $Locked.Fullname
Write-Host "commencer" -NoNewLine
##############Restore admin access & then restore file/folder inheritance on all subitems
#create a template ACL with inheritance re-enabled; this will be stamped on each subitem to re-establish the file structure with inherited ACLs only.
#$NewOwner = New-Object System.Security.Principal.NTAccount("$domainName","$Locked.name") #ideally I would error check this.
$NewOwner = New-Object System.Security.Principal.NTAccount("$domainName","$Locked") #ideally I would error check this.
$subFileACL = New-Object System.Security.AccessControl.FileSecurity
$subDirACL = New-Object System.Security.AccessControl.DirectorySecurity
$subFileACL.SetOwner($NewOwner)
$subDirACL.SetOwner($NewOwner)
######## Enable inheritance ($False) and not copy of parent ACLs ($False)
$subFileACL.SetAccessRuleProtection($False, $False) #SetAccessRuleProtection(block inheritance?, copy parent ACLs?)
$subDirACL.SetAccessRuleProtection($False, $False) #SetAccessRuleProtection(block inheritance?, copy parent ACLs?)
#####loop through subitems
$subdirs = Get-ChildItem -path $Locked.Fullname -force -recurse #force is necessary to get hidden files/folders
foreach ($subitem in $subdirs) {
#take ownership to insure ability to change permissions
#Then set desired ACL
if ($subitem.Attributes -match "Directory") {
# New, blank Directory ACL with only Owner set
$blankdirAcl = New-Object System.Security.AccessControl.DirectorySecurity
$blankdirAcl.SetOwner([System.Security.Principal.NTAccount]'BUILTIN\Administrators')
#Use SetAccessControl to reset Owner; Set-Acl will not work.
$subitem.SetAccessControl($blankdirAcl)
#At this point, Administrators have the ability to change the directory permissions
Set-Acl -aclObject $subDirACL -path $subitem.Fullname -ErrorAction Stop
} Else {
# New, blank File ACL with only Owner set
$blankfileAcl = New-Object System.Security.AccessControl.FileSecurity
$blankfileAcl.SetOwner([System.Security.Principal.NTAccount]'BUILTIN\Administrators')
#Use SetAccessControl to reset Owner; Set-Acl will not work.
$subitem.SetAccessControl($blankfileAcl)
#At this point, Administrators have the ability to change the file permissions
Set-Acl -aclObject $subFileACL -path $subitem.Fullname -ErrorAction Stop
Write-Host "." -NoNewline
Write-Host "fin."
Write-Host "Script Complete."
I hope you find this useful.
Thank you,
Tony
Final Thought: There are great non-PS tools like
Set-Acl and takeown which are external to PS & can also do the job wonderfully. It may be much simpler to call those tools than recreate the wheel in pure
code. Feel free to use whatever best suits your time, scope & cost.

How to prepare SRS and FS documents for a GxP critic processes

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