fMVP One is ready to be validated per 21 CFR Software Validation Guidelines. If you are interested in more details, please reach out to your Customer Success agent. If you do not know who this is please contact Technical Support via Live Chat for further assistance.

 More information on the specific tests can be found below: 

 

MVP One Standard Software Validation Controls:

1. System Access     
   1. The system shall only allow as many users to login as there are concurrent licenses for the system. The number of concurrent licenses in the system shall be found in the licenses module of the system. NON-QS REQUIREMENT.     
   2. The system shall restrict access to those with authorized access. [Required per 21 CFR 11.10 (d)]  
   3. The ability to Login to the system with a USER ID and PASSWORD created by an administrator in the Users Module of MVP One.  
   4. The system shall restrict access to the system based on the user’s assigned roles as set by an administrator in the Users Module of MVP One.
   5. The ability to Logout of the system and prevent data access once a user has logged out of the system.  
   6. All valid user Login/Logout attempts shall be logged by the system with USER ID, date/time and Operation attempted, and a report shall be able to be generated by authorized users of the system.  
   7. The system shall automatically de-authorize a USERID with 5 consecutive failed login attempts. [21 CFR Sec. 11.300 (c)]  
   8. Each USERID in the system must be unique. [21 CFR Sec. 11.300 (a)]  
   9. The ability by the logged in user of the system to change their password by entering the current password, and the new password twice.  
   10. Only administrator level users can reset a user’s password  
   11. Only administrator level users can unlock/lock a user account  
2. System Settings 
   1. The system settings are only accessible by users with authorized access. [21 CFR Sec. 11.10 (k)(1)]  
   2. All changes to settings will be logged with the USER ID of the user making the changes as well as the date/time and the old and new values for the setting being changed. [21 CFR Sec. 11.10 (k)(2)]  
3. User Management 
   1. The system shall allow users to be added to MVP One by administrators of the system. [21 CFR Sec. 11.10 (g)]  
   2. The system shall provide the ability for administrators to manage and maintain master setup of users, assign user roles, user settings, and password administration. [21 CFR Sec 11.10 (g)]
   3. The ability for administrators to define roles, which provide the rights allowed within the system, shall be allowed for each administrator. [21 CFR Sec 11.10 (g)]  
   4. The system shall allow administrators to create, edit, and delete roles. [21 CFR Sec 11.10 (g)] 
4. Work Orders 
   1. The system shall allow the creation, deletion, and editing of Work Orders by authorized users. [21 CFR Sec 11.10 (g)]  
   2. The system shall require a labor transaction to a work order before it can be changed to completed status within the system. [21 CFR Sec 11.10 (f)]  
   3. The system shall track inventory parts, tools, or repairable spares checked out to / returned from work orders.  
   4. Work order history shall be accessible from Equipment, Repairable Spare, or Location records where the work was performed, by authorized users.  
   5. The system shall require all Instructions and Instruction steps to be completed in order for a Work Order to be changed to completed status. [21 CFR Sec 11.10 (f)]  
   6. The system shall automatically generate the Work Order ID when a new work order is created. [21 CFR Sec 11.10 (f)]  
   7. The system shall track changes to work order status with the Work Order Status, USER ID, and date/time [21 CFR Sec 11.10 (e)]  
   8. The system shall log individual instructions with date/time and username when they are checked off as completed. [21 CFR Sec 11.10 (f)] [21 CFR Sec. 820.70 (g)(1)]  
   9. Labor transactions to Work Orders in the system shall contain the People ID of the employee who performed the work, the date the work was performed, and the Hours and/or OT Hours of the work performed. Additionally, the USER ID of the user who created the record and the date/time the record was created as well as the location of the entry (website, mobile, etc..) shall be recorded.  
   10. When a work order is closed the date/time and username of the user closing the work order shall be logged by the system.  
   11. If a work order is reopened after having been closed the date/time and username of the user reopening the work order shall be logged by the system and shall be accessible from the Comments tab of the record.  
   12. A closed work order shall be accessible as a PDF from the Work Order History.   
   13. A work order shall be accessible as a PDF from the Work Order’s entry in the system.  
   14. Generating a report for a Work Order will show the approval chain for the Work Request that generated the Work Order if applicable.  
5. Work Requests  
   1. Work requests shall be able to be created by users within the system who have proper privileges.  
   2. The system shall allow authorized users to convert Work Requests to Work Orders.  
   3. The system shall allow authorized users to reject, approve, or place Work Requests on hold. 
   4. The system shall log status changes to Work Requests with the Work Request Status, USER ID, and date/time of status change.  
   5. The system shall allow approval chains to be designated for work requests before conversion to a Work Order.  
6. Preventative Maintenance 
   1. New PM templates will only be able to be created by users who have been authorized to do so within the system. NON-QS REQUIREMENT.  
   2. PM templates shall require approval by an authorized user to be active within the system. The system shall maintain the username of the approver along with the approval date within the PM record.  
   3. The system shall allow the scheduling of PM tasks based on Meter Readings and/or on a calendar-based schedule.  
   4. Preventative Maintenance Work Orders that start within the next 7 days shall be generated by the system each night and logged in the generation log.  
   5. Preventative Maintenance Work Orders shall be able to be generated manually by users with proper privileges and shall be logged in the generation log.  
   6. PM templates will only be editable by users who have been authorized to do so within the system  
   7. Equipment Maintenance Records  
   8. Work Orders Assigned to Equipment shall be accessible from the Equipment Record  
   9. Work Orders in Work Order History shall be accessible from the Equipment Record