For quite some time, most organizations were required to track regulatory compliance through spreadsheets and external databases, but as enterprise resource planning (ERP) systems have evolved, regulatory compliance tracking capabilities have improved. Now, with real time access to information and automation, it’s easier than it has ever been for an organization to ensure that regulatory compliance challenges are being not only met, but exceeded.
This doesn’t mean spreadsheets and paper-based tracking aren’t effective-those processes and procedures have done the job for some time. However, it takes time to manually track all of the data necessary to ensure compliance and manually tracked data is error prone as numbers get transposed or missed entirely. The repetitive nature of manual data entry can lead to simple mistakes that lead to loss of brand value or, worse yet, can put an organization out of business.
Visibility and Controls
A major element of regulatory compliance in all controlled industries is the visibility and transparency of business processes. From acquiring the materials or products for production through final delivery to the customer, organizations must be able to track material flow to meet compliance guidelines. ERP enables this visibility and transparency through functionality such as lot/serial traceability from design through manufacture, electronic signatures for audit traceability and storage and transfer movements.
Data Security and Access Controls
Whether securing the property rights of the products produced or tracking data that is collected, one increasing concern is controlling breach of data security. ERP systems should provide a complete set of security features including access controls, data encryption, and server based processing.
- Tailored Security Measures – Configure the system security to be as finely tuned as your operating environment requires
- Controlled Access – Standard security features include password control at the role, group or operator maintenance facilities. Administrators can also control access down to certain business processes, companies, modules, menus, and program functions and activities
- Segregation of Duties – Transactions (financial and data) should be authorized by at least one individual not directly connected with the transaction
- Data Encryption – ERP Security features give you visibility to transactional data
- Audit Trails – Master data amendment journals and transactional audit trails provide records of data changes and the users responsible. The job logging facility provides an audit trail of user access and processing activity
- Electronic Signatures -Secure transactions by authenticating the operator who is performing the transaction. This can be configured to create a summary and detailed log of all transactions
Traceability and Quality Control
Traceabililty goes hand in hand with visibility and transparency. The need for product traceability is critical in a compliance-regulated environment, lot traceability is a supply chain issue, not just a manufacturing issue. Most ERP systems pro¬vide a comprehensive framework for managing product innovation with solid product data management, quality process controls and cradle-to-grave product traceability. ERP systems also streamline the process of tracking such issues as nonconforming products or customer complaints in an efficient manner. The result is better-quality products because quality issues are caught and addressed more quickly.
- Trace a product’s life cycle-from design through manufacture to post-sale
- Record Retention – Must be maintained for qualified processes, equipment and personnel
- Inspection Controls – Store and track evidence of tests performed to ensure materials meet quality standards operator maintenance facilities. Administrators can also control access down to certain business processes, companies, modules, menus, and program functions and activities
- Segregation of Duties – Transactions (financial and data) should be authorized by at least one individual not directly connected with the transaction
- Data Encryption – ERP Security features give you visibility to transactional data
- Trails – Master data amendment journals and transactional audit trails provide records of data changes and the users responsible. The job logging facility provides an audit trail of user access and processing activity
- Electronic Signatures -Secure transactions by authenticating the operator who is performing the transaction. This can be configured to create a summary and detailed log of all transactions
Traceability and Quality Control
Traceability goes hand in hand with visibility and transparency. The need for product traceability is critical in a compliance-regulated environment, lot traceability is a supply chain issue, not just a manufacturing issue. Most ERP systems provide a comprehensive framework for managing product innovation with solid product data management, quality process controls and cradle-to-grave product traceability. ERP systems also streamline the process of tracking such issues as nonconforming products or customer complaints in an efficient manner. The result is better-quality products because quality issues are caught and addressed more quickly.
- Trace a product’s life cycle-from design through manufacture to post-sale
- Record Retention – Must be maintained for qualified processes, equipment and personnel
- Inspection Controls – Store and track evidence of tests performed to ensure materials meet quality standards
- Control Numbers – Assign a unique identification number to raw material receipts and production batches
- Equipment Controls – Documented proof of calibration and testing equipment used in the production process that can affect the products quality
- Document Controls – Manage and track documents such as engineering specifications, material specifications and operating procedures.
Regulatory compliance is a growing concern for any regulated industry and as the number of regulations and standards increase, you need an ERP system that can address this ever evolving environment. SYSPRO’s software solution is designed to help organizations address and manage compliance guidelines to streamline the processes and make it easier and less time consuming than using a manual labor intensive system.
