Implementation of Electronic Records and Electronic Signatures(ERES)

Companies whose manufactured products and processes, such those in life sciences (medical devices, pharmaceutical, biotechnology, biopharmaceutical) food and beverage and some chemical companies, are increasingly regulated by government agencies.  These manufacturing companies must keep detailed records of their design, inventory and product manufacturing processes. Current practice in these many of these regulated industries is to maintain paper records of all information pertaining to the manufacture of their products.

More companies want to maintain and store these records in electronic format to reduce this paperwork burden. This is of particular importance for regulated industries in light of the Food and Drug Administration’s (FDA) regulation on electronic records and signatures called 21 CFR Part 11.

Oracle Electronic Records and Signatures is a configurable framework for securely capturing, storing, retrieving and printing electronic records and signatures. Critical supply chain management business events are now enabled in the areas of inventory, manufacturing, quality and shipping.

Inline processing is supported when a signature needs to be captured immediately, so you do not delay further processing. If multiple signatures are required, the screen captures the first signature, then a notification is sent to subsequent approvers to capture the remaining signatures. If the signers are not available immediately, the Back button is available to return to the transaction in progress. The new or updated transaction data is not committed to the database and is held in a pending status until all approvals are complete.

The e-signatures and e-records approval processes can be of the following types:

Inline approval process: In this process, approvals must be obtained before a transaction is saved. You can’t save a transaction if the record is rejected.

Deferred approval process: In this process, transactions are saved in Pending Approval status before initiating the e-signature process. The transaction is updated to Approved status after the approvals are obtained