The Document Section in SOLABS QM10 is designed to manage the life cycle of controlled documents, from authoring, review/approval, revisions and ultimately retirement. The related tools and processes in SOLABS QM10 support that goal - such as managing document permissions, creating Document Types, creating Document Workflow Templates, creating PDF Rendering Templates, linking documents to Training Activities, etc.
However, many clients have needs to simply use the Document Treeview to house documents that will be imported and stored but not managed within the system. These needs could be for such things as
- Scanned copies of records from outside partners such as contract manufacturers or laboratories
- Importing scanned copies of paper records as Certified Copies to alleviate the need for storage of the paper records.
- The ability to establish related metadata for records and easily search/trend the related information
When considering whether to use SOLABS QM10 to simply import and store documents, realize that it was designed to manage controlled document life cycles. Therefore, you will need an Approval Cycle with at least one assigned approver in order to import and store a document. If these documents need to be searchable, require frequent access and use, need to be linked to Training Activities or used as Related Documents in a Process (Change Control, Deviation, etc.) you can benefit from the capabilities of SOLABS QM10 through import with just the one approval. If they simply need to be archived, and rarely used, there may be solutions and services other than SOLABS QM10 that can meet that need more easily for you.
After deciding to use SOLABS QM10 for these document needs, consider the following possibilities in order get the most benefit from that decision. Then define your process in a local SOP.
- Create Document Treeview Folder locations specific to these documents and apply appropriate privileges to them.
- Create unique Document Types that will allow you to define Standard Attributes, set Default Locations and to create System Attribute fields for any metadata that would be helpful to search on.
- Is the document related to a certain product, submission, contract organization, etc.
- Would a field for page count verification be helpful if importing as a Certified Copy?
- Create a Document Workflow Template for Author (Originator) approval will facilitate approval by the person performing the import of the document.
- Name the Workflow Template accordingly - such as Legacy Document Import, Certified Copy, etc.
- Set default relationships between the Workflow Templates and the Document Types
- If you are planning to import the documents as PDF files, and want them to remain "as is", consider creating a PDF Rendering Template that does not include the SOLABS Cover Pages or any watermarks and headers.
- Create unique values for the Meaning of Signature for these documents - such as Certify True Copy, Document Import, etc.
- Approval Signature Meanings come from an editable Custom List (System_List_Sign-off_Meaning) with two defaults: Author (Originator) and Approver but can be modified to add other values.
After planning how you will best use SOLABS QM10 to meet your storage needs, and updating your local SOPs to describe the process you are ready to import your documents!
Use the established process for Creating and Approving Documents in SOLABS QM10.
- Click Create Document
- Import file
- Choose Document Type
- Enter document metadata
- If you created a Default Workflow Template for Author-Only approval, you can go right to the next step because it will apply automatically. If you need to have a different set of approvers for a particular document, you can choose the Set Workflow option to change to something other than the default.
- Click "Start Approval Cycle" from the right-hand menu and Submit/Confirm
- If you are the one approving, you can immediately choose "Approve/Reject" from the right-hand menu
- Open the document (required for approval) and verify you have imported the correct one
- Approve the document using any specific Meaning of Signature you may have created
You are all set!! If you have more of the same types of documents to import, you can also make use of the Auto-populate fields from option!