Demonstrate Regulatory Compliance
through Validated Manufacturing Operations

Regardless of your industry, every manufacturer has its own set of corporate, customer, industry or government regulations which must be adhered to. Complicating matters further, these regulations seem to grow in complexity, resource need and reporting requirements. While each mandate may be unique, several common denominators tend to be globally relevant for manufacturers: 

• Consistent execution of processes to ensure consistent operations, both within a particular location and across the enterprise
• Enhanced audit mechanisms to demonstrate processes have been consistently followed, as well as audit trails to show when changes are made and who authorized the change; this requirement also includes the need for full traceability, should the need arise for a recall
• Greater operational visibility and control, across all areas of manufacturing operations execution

Consistent Execution of Processes

Establishing a process is easy; having it repeated thousands of times a day across multiple locations by multi-cultural employees speaking in different languages is tough. Yet, this type of consistency is a cornerstone to achieving regulatory compliance. Obviously, these tasks can’t be relegated to manual processes – every step must be automated whenever possible, reducing the possibility for human error. Processes must then be improved upon, driving out inconsistencies, waste or unnecessary time and resources.

By supporting multi-location manufacturing operations, Apriso has no problem in ensuring processes are maintained across your entire enterprise, not just at one particular location. As an example, when it comes to achieving regulatory compliance for FDA related regulations, this can be an enormous time and resource-saving feature, one that could be leveraged to provide a much higher level of adaptability, should your market conditions or industry requirements change suddenly.

Achieving regulatory compliance need not be a mindless exercise to address regulations and file reports. Instead, they should be viewed as an opportunity to streamline operations, increase production performance and leverage as a sustainable competitive advantage. With a unified data infrastructure based on a business process architecture, Apriso makes it easy to establish repeatable processes, test their effectiveness, and then deploy them widespread throughout your organization. And, as regulations are changed, updated or replaced, Apriso makes it easy to perform updates to your processes, ensuring you remain in compliance without the burden of deploying expensive IT resources to re-build your manufacturing operations execution systems.

Greater Operational Visibility and Control

Government, corporate and industry regulations all seek specific actions to be followed, processes to be established and a means of demonstrating compliant behavior. Without complete visibility to operations – across your enterprise – it is unlikely you can achieve complete compliance. And, when regulations pertain to manufacturing operations, that visibility must extend throughout your supply chain.

With the global expansion of supply chains, manufacturers face increased complexity in managing their operations. For example, in Life Sciences manufacturers face additional challenges with the growing list of government mandated regulations pertaining to suppliers. To remain competitive, companies need visibility and control over theirs and others plant operations to ensure that processes meet compliance.

Apriso provides visibility into each of the operations systems surrounding production, maintenance, inventory and supply chain monitoring, as well as overall quality control processes.

Enhanced Audit Mechanisms

As the final step in the closed loop process to achieving regulatory compliance, all applicable processes must now be documented to prove they have been adhered to, and any changes must be logged for future retrieval should the need arise from an audit. Here is where the benefits of an automated system built with a business process architecture can pay off. Without manual intervention, it is possible to provide the necessary proof, demonstrating 100% achievement of necessary compliant actions. With included security and profile capabilities, Apriso tracks each time a process change was authorized, ensuring a complete process log to perform an audit or process diagnostic review.

And, as those in the Automotive and other industries can testify, demonstrating complete traceability and visibility across your supply chain can make a routine product component recall cost thousands of dollars, instead of millions.

Apriso Enables Cost Effective Compliance

Whether you are regulated by FDA 21 CFR Part 11, Sarbanes-Oxley, Tread Act, European Food Safety Authority Initiative, FDA’s PAT Initiative or the Bioterrorism Act, the time and resources you must allocate to address compliance initiatives is staggering. Deploying and maintaining unique solutions for each new mandate can consume extensive resources including systems, training, and personnel. And, with new and revised mandates appearing at a rapid rate, controlling the escalating cost of compliance is a challenge at best.

The cost of non-compliance carries severe penalties – including plant shut downs, fines and even criminal prosecution. Apriso’s adaptive operations execution platform enables you to cost effectively react to this changing regulatory environment, by providing a system for greater visibility and control, a consistent execution of processes coupled with enhanced audit mechanisms and traceability capabilities. The platform’s flexible technology lets you easily integrate compliance policies and practices into your operations processes and policies. By providing visibility and agile business process authoring capabilities, Apriso provides a flexible foundation for support of your compliance and corporate governance initiatives.

Find Out How Apriso Helps Address Regulatory Compliance in Manufacturing:


Achieving Compliance and Manufacturing Excellence in the Life Sciences

Aberdeen Report: British American Tobacco Leverages Apriso for a Proactive Lead on Compliance and Traceability