More and more, companies are under pressure to maintain their competitiveness while complying with an increasing array of regulatory requirements. And more than any other sector, manufacturers bear the highest share of the cost. How companies manage their response to these mounting regulations can have a significant impact on the bottom line. And having a process in place that is capable of collecting the information needed – while being easily tailored to specific company requirements – is paramount to the success of the business.
An ERP solution, which include integrated functionality to promote compliance, plays a central role in regulatory compliance. Because it maintains one common database, the ERP system can help minimize reporting costs by providing a convenient and efficient way to gather and monitor relevant information and eliminating manual procedures throughout the manufacturing process.
An advanced ERP solution will enable manufacturers to capture information electronically, helping them to achieve better compliance and to save the huge costs of managing paper-based systems. It can also increase the speed of product release, identify supplier issues and gain agility by being able to obtain the needed information quickly. These important features help ERP systems meet regulatory compliance standards :
- Lot Traceability. ERP solutions utilize traceability as a competitive advantage by automating and giving visibility to continuous improvement initiatives. When lot traceability and automated batch processing information is easily accessible to those who need it, root cause analysis and real-time CAPA (corrective and preventive actions) become attainable best practices.ERP systems manage complete forward and backward traceability for each ingredient and finished product, as well as include user-defined technical sheets and operational detail instructions, along with lot and sub-lot control.
- Audit Trail. Audit trails are essential to address compliance requirements for how data is obtained, used, managed and secured. The ERP system authenticates user names, dates, times, previous data, new data and the reason for the change. Additionally, it maintains an archive of historical transactions for multi-year periods.
- Digital Electronic Signatures. With digital electronic signatures, companies can improve security and control over their internal automated workflow, which are required for passing corporate governance audits in addition to complying with various industry regulations. The ERP system provides an electronic signature framework which includes tables, programs, actions and objects to store, configure and collect unique e-signatures that are permanently linked to the object and can not be modified or copied.
- Quality Control. A fully integrated quality control process helps companies automate and streamline their paper processes for increased efficiency and regulatory compliance. Through a rules-based orientation, the ERP system enforces inspections at key event points to assure item conformance to any required product characteristics, operational tolerances or expected results. The system automatically quarantines items that fail any inspection rules, as well as suspicious items, and designates them for disposal or further inspection.
- Document Signatures. For documents requiring handwritten signatures – such as Certificates of Analysis or Technical Sheets – scanned, digital or flattened digital signatures are appropriate. The ERP system generates documents with an image linked to the specific document and controls the image plate while linking it to the user profile.
- Security Features. It’s important to have security standards in place to safeguard against unauthorized use of the system and protect against both outsider crime, like industrial espionage, and insider crime, like embezzlement. The ERP system includes features for automatic log-off after a period of inactivity, automatic log-out after too many failed log-on attempts and logging of all user activity.