In Validaide, it is possible to create digital SOPs (Standard Operating Procedures) which helps you to further digitize your documents and manage them more effectively. In many cases, SOPs for pharmaceutical logistics require alignment and approval between multiple parties, such as a shipper and forwarder, or forwarder and carrier. With Validaide, we enable digital collaboration, with joint editing and online approval of SOPs between multiple parties.
SOPs can be edited according to your needs, based on a default template for the process steps to provide you with an initial setup. But this can be edited in a flexible way, steps can be deleted, modified or added. You can link Lanes to your SOPs and the contact details of the involved parties can be taken from Validaide automatically, saving you a significant amount of time as you do not have to fill them in manually.
The Lane SOPs can be shared with external parties such as a Customer or Carrier on Validaide. An approval workflow can be set, enabling joint editing and online approval with digital signatures.
Note: When submitting, approving, removing, and restarting the workflow of the SOP, your email and password must be entered to approve with a digital signature.
Below see an example of a part of the SOP Overview
Create a new SOP
To create a new SOP, go to the SOPs menu and click on the dark blue "Create SOP" button.
This will create the following form to enter the basic information about the new SOP:
Transport SOP – the most common SOP used in Validaide to capture the Standard Operating Procedures between forwarders and manufacturers regarding transportation logistics.
Warehouse SOP – the Standard Operating Procedures set up between a manufacturer and a freight forwarder or warehouse management, the company that is running a warehouse for you.
Route Evaluation – this is not an SOP but uses the same module. The Route Evaluation is used to compare lanes or describe the lanes and lane assessments in more detail.
The same lane can be attached to several different SOPs. Lanes can be categorized into – “Unassigned, Primary, Back-up, Pre-carriage, and On-carriage”. Lanes can be attached and categorized by Manufacturers and Forwarders.
Notes:
- Additional information such as Internal Reference, Description, and Incoterms can be added later in the SOP Configuration
- You can assign the various Parties involved in the SOP, such as the Forwarder, Customer, Primary Carrier, 4PL, Importer of Record and Exporter of Record.
- You can choose if you wish to use our default template for the Process Steps which can be edited in a flexible way. The default Process Steps include Booking, Origin Process, Customs Clearance Export, Destination Process, Temperature Monitoring, Invoicing and some others.
- You can directly start the approval workflow for the SOP, or do this at a later stage. If you start the workflow you set a review period, and Responsible user and internal Approver(s). External Approvers can be added after you start to share the SOP.
Watch the video about creating SOPs:
Assigning additional users to sign that they have Read and Understood the content of the SOPs
Pharmaceutical companies operating under GxP often need additional stakeholders, beyond the formal approval workflow, to confirm that they have read and understood an SOP.
Validaide enables all relevant stakeholders, also those outside the approval workflow, to efficiently acknowledge SOP awareness directly within the platform, eliminating the need for duplicative export-and-upload steps.
A new optional drop-down field is displayed under the User Roles card for assigning Read & Understand users. These are active Validaide users who are not part of the original workflow, but can still be assigned to a specific SOP to confirm awareness. These additional users can hold any user role (e.g. Tenant Administrators, Editors and Viewers). It is possible to assign up to 6 internal and 6 external stakeholders to sign off on an SOP. External stakeholders may be from multiple companies and each company can have up to 6 assignees. Users, that are not part of the workflow, and are only assigned to sign off on the SOP cannot modify the SOP content. Their only task is to provide their signatures on the SOP and acknowledge that they understand the associated process.
The assigned users are visible not only on the User Roles card but also in the Version Control tab.
Users can be assigned to an SOP in these statuses:
- In progress
- In internal review
- In internal QA review
- In external review
- In external QA review
- Approved
- About to expire
However, users cannot be assigned to an SOP in the following statuses:
- No workflow
- Expired
Notification for the users:
The users assigned to Read and Understand the SOP will receive both an email and in-app notifications in Validaide prompting them to sign the SOP.
Note: Only SOPs with Approved or About to Expire statuses can be signed. These users should acknowledge only the final, approved process of the SOP. Therefore, they do not receive a notification when assigned to an SOP in any other status. They are notified only when:
- the SOP becomes Approved,
- they are assigned to an already Approved SOP,
- They are assigned to an SOP that is About to Expire.
If users are assigned in any other workflow status, they will receive a notification to sign only once the newest version reaches Approved status.
If the workflow is restarted, these users will no longer be able to sign the SOP. They can sign again only after the SOP is approved again, and they will receive a new notification to sign the latest approved version of the SOP.
Users who have not yet signed the SOP will receive weekly reminder email, as part of the standard reminder process, as long as the SOP remains in Approved or in About to Expire status.
Electronic signature.
Users, assigned to an SOPs to confirm that they understand the content must provide an electronic signature in Validaide.
User suspension.
If a user assigned to an SOP is suspended, their tasks must be reassigned to another active user in Validaide. Task and roles can be reassigned only to users with Administrator and Edit rights.
The signing action is recorded in the SOP Audit Trail, the Tenant Administrator Audit Trail and the Version Control tab.
Edit Processes for an SOP
In the Processes tab you can edit the process groups and process steps.
If you have selected to use Validaide's default template, it is already filled in with the process groups, which can be easily customized.
You have the following options to edit Process Groups and Processes:
-
Renaming: the groups can be renamed by clicking on the corresponding pencil icon,
-
Removing: the processes can be moved by clicking on the trash can icon
-
Image Upload: you can add images and files to the process with the upload icon:
-
Change the order: you can move a Process up or down in the list with arrow icons:
More process groups can be added with the "Add Process Group" button
at the bottom of the page.
Within the process groups new process steps can be added if you click on the Add Process button . Similarly to the process groups, the steps can also be modified or removed.
Edit Contacts for an SOP
In the Contacts tab you can edit
the contact details of different contact groups.
By default, you have the contact groups for your company and for your customer already added.
In case you have added Lanes to the SOP, the contacts of the GHAs, air carriers and road transporters are automatically added to the contact details in the Contact tab.
Please note that if you later remove a lane, the contacts for it are not removed automatically.
These Groups can all be edited and removed in a flexible way, according to your needs with the corresponding pencil and trash can icons on the right.
New Groups can be added easily with the Add Contacts Group at the bottom of the page
Note: Users can download an SOP as a PDF file.
Comments
0 comments
Please sign in to leave a comment.