The US Government has increased rules and regulations for manufactured products and processes of various industries. It is mandatory for manufacturing companies to keep detailed records of their processes, inventories and designs. However, the trend for bookkeeping in these companies has been manual and traditional over the years.
The trend is changing now as more and more companies are willing to maintain and store their records in the electronic format. This shift has reduced paperwork and helped companies to achieve compliance with the US Food and Drug Administration’s (FDA) 21 CFR Part 11 regulations.
Now, Oracle for Electronic Signatures and Electronic Records provides a configurable framework for securely capturing, storing, retrieving and printing electronic records and signatures. The critical business events in Oracle Supply Chain Management have been enabled in the areas of product design, inventory, manufacturing, quality, purchasing and shipping.
- Manufacturing Standard Operation Management
- Work Order Material Transactions
- Work Order Operation Transactions, and
- Order less Transactions
Let’s understand how this helps a company from a manufacturing perspective and enable electronic signatures for the below:
A user can review electronic records that are generated automatically and capture electronic signatures inline for standard operations as well as for work execution transactions. And in addition to this, a user can also search and retrieve the related E-records through the electronic records work area.
Manufacturing Standard Operation:
The e-record which gets generated automatically for a standard operation contains the following information:
- Standard operation details
- Resource details
- Alternate resource details
Work Order Material Transactions:
The e-record which gets generated for a work order material issue or return transaction contains the following information:
- Work order details
- Operation details, and
- Material transaction details along with material lot and serial details
The process to generate an electronic record and capture electronic signatures is initiated only when an operation transaction is submitted using Quick Complete or Complete with Details actions in the review dispatch list page or manage supplier operations page.
Work Order Operation Transactions:
The e-record which gets generated for a work order operation transaction contains the following information:
- Work order details
- Operation details
- Inspection details
- Operation transaction details
- Product transaction details with product lot and serial details
- Backflush material details with a material lot and serial details
Also, it’s important to note if multiple transactions such as complete, scrap and reject are reported through a single user action, then a single electronic record is generated which contains transaction details reported.
Order less Transactions:
The e-record which gets generated for an orderless completion or return transaction contains the following information:
- Order less transaction details
- Inventory transaction details along with product lot and serial details, and
- Backflush material details along with material lot and serial details
Once a user enables E-signatures and E-records for standard operations management and work execution transactions, the inline E-signature capture process is initiated when the transaction is submitted for approval. E-records are generated and the electronic signatures are captured before the transaction is saved. Notifications are sent to the approvers, which can be accessed through the bell notifications in the Oracle cloud application or through email. The approvers can review the E- records before adding their E- signature. Approvers can add their comments, indicate their approval or rejection and sign the E-record by entering their password.
The approvers also have access to view the current status of the approval process through the approval history region in the inline signature capture page and in the notifications. The standard operation creation or update or work execution transaction is either saved or rolled back and is dependent upon the approval outcome.
A user can search and retrieve electronic records in an e-record work area using multiple search criteria such as the contents of the report title, the transaction type, organization, last signed date or status. It is to note that the e-records are stored in a secured document repository and cannot be modified or deleted. Though, Oracle E-signatures and E-Records stores both the approved and rejected records.