Strict adherence to the Food and Drug Administration’s (FDA) and Safe Quality Food Institute’s (SQF) regulatory requirements, as well as the ability to provide an audit trail reporting on them when necessary, is of great importance to many of our manufacturing customers. This is especially true for those who do business in industries regulated by these governing bodies.
As the provider of an ERP solution with one of the largest functional foundations, Deacom has built-in process controls and auditing capabilities for customers to meet these requirements.
Here’s how we do it.
Formulation
- Provision control
- Modification log
- Assign QC testing info
- Workflow w/e-signatures
DEACOM ERP software provides a complete audit trail of the formulation process, including revision control and change recording.
The modification log records all historical copies of revisions that show when a bill of materials (BOM) was changed, who made the change, and anything that may have been done to that BOM that would be required as part of an audit trail.
An additional process control step that may be implemented is when a formulation needs to be updated. In those cases, the entire R&D workflow will be reset and require completion before the new revision becomes active.
Production
- Batch ticket archiving
- Lot traceability
- Regulatory reporting
Batch tickets are what govern the entire production process. This is typically the binding document that the FDA requires during an audit and is one of the reasons why it is archived in the system.
Lot traceability in DEACOM ERP software provides the ability to see every lot that went into a particular job as well as details for reports. This includes full contact information for customers who received those lots – information that is required by the FDA to increase the speed of recall management.
Lot tracking reports provide full traceability including a list of raw materials used in the production of a finished good or the finished goods produced from a single raw material. Reports also provide details on who made the transaction and when.
Regulatory reporting capabilities include the ability to print SARA 312 reports and TTB reports.
Quality Control
- QC testing and recording
- QC hold/release
- eSignature requirements
One of the benefits of having Quality Control functionality built into Deacom’s ERP system is that QC holds can be enforced on all products. This requires that all tests are passed and their results recorded in DEACOM before a product is shipped or used elsewhere down the line. As a mandatory step, this auditable process control can be built directly into standard operating procedures.
DEACOM ERP software encrypts QC results in the database using the AES-256 encryption method. This meets the additional security requirements set forth by the FDA’s 21 CFR Part 11 regulations.
Electronic signature requirements also dictate that an operator must enter their username and password when finishing QC results or updating workflow steps. This verifies the identity of the user and provides process control for the audit trail.
Shipping
- Expiration date management
- FEFO lot selection
- QC hold prevents shipments
- Document groups (COA, BOL, Customer invoice, International documents)
FEFO inventory selection is built into DEACOM ERP software, so the system will always identify the first product that is going to expire and meets shelf life requirements of customers.
Tied back to Quality Control management, any lots that are in QC hold cannot be shipped.
When products are ready to be shipped, DEACOM provides the ability to print a Document Group – an automatically generated set of documents that meet the shipping requirements of specific customers. This will often include the bill of lading, the Certificate of Analysis, packing lists, and any documentation necessary for international customer shipments.
Unlike other systems, Certificates of Analysis in DEACOM are linked directly to the QC results, making the automated process of generating them much more efficient.
