Companies spend a significant amount of time doing compliance reporting. Oftentimes, errors are made during the filing process due to the complexity of the process and lack of visibility into data. The burdens of compliance reporting have many organizations seeking alternative ways to streamline their processes and mitigate risks. More importantly, the cost of non-compliance is 2.71x more than the cost of compliance itself – increasing the financial implications for a less than perfect filing process.
For many, the answer is in integrating Manufacturing Intelligence solutions to reduce compliance filing errors and provide greater visibility across the organization. Through automated data collection and validation, these platforms ensure consistency for regulatory requirements and improve accuracy by centralizing data and providing end-to-end tracking capabilities.
Identifying Errors in the Compliance Reporting Process
Although manual compliance reporting is time-consuming and error-prone, it isn’t the only offender when it comes to compliance mistakes. There are additional factors, both internal and external, that contribute to added costs and increased complexity.
Errors in compliance filing are also caused by the following factors:
Paper Batch Records
As a compliance requirement, pharmaceutical batches must be tracked and documented per the Code of Federal Regulations Title 21 part 188. It is crucial for every detail from materials used to production times to be documented accurately.
For this process, its common to use paper batch records, however with this there is increased probability of human errors, including production miscalculations, write-overs, and missing data
Being able to gain access to this data quickly minimizes the risk of errors. With Manufacturing Intelligence solutions in place, organizations can reduce compliance filing errors and redundancy, streamline data and reduce overall costs. By using cloud-based technology, data can be collected, stored, and analyzed in real-time – allowing companies to spend more time getting their products to market.
Just as an organization is responsible for reporting its regulatory compliance, so are the third-party vendors that provide them with products or services. This is an example of an external factor that increases the risk for non-compliance. This factor is especially critical for multinational companies that work with varying vendors located across multiple countries with different regulations.
Ensuring that third-party vendors are adhering to the same regulatory standards as the organization they are working with is critical to minimizing risk. A comprehensive appraisal of business partners, vendors, and service providers is the first step when it comes to the compliance filing process. At this stage, most organizations fails to assess and criticially examine their vendors’ and partners’ ability to deliver relevant documentation needed for compliance reporting. This is a massive liability with a wide range of repercussions both financially and operationally for the organization.
Removing these external factors isn’t an option, but leveraging technology to help with the execution of due diligence is. With regulatory agencies becoming increasingly more strict, organizations can no longer proceed “business as usual” without the proper systems in place.
The third example of contributing factors for compliance filing errors is siloed data. Data trapped in siloes inhibits collaboration between departments and creates barriers to information sharing. Not only is this a roadblock to company-wide efficiencies, but it is also a cause of increased errors and oversight in the compliance filing process. Without a single pane-of-view of data, there is no single source of truth — making it difficult to make informed decisions when it comes to regulatory compliance.
Unlocking siloed data is essential for organizations looking to eliminate compliance filing errors. Beyond just compliance purposes, having access to data across departments allows deeper insight into the performance of the entire organization.
Achieving Regulatory Compliance With Mareana Manufacturing Intelligence
As companies grow, so does the risk of compliance filing errors. The need for centralized data governance is critical for minimizing regulatory compliance mistakes.
Mareana Manufacturing Intelligence incorporates various operational data sources for process analytics, FDA reporting, in-process control charts, and real-time verification. Organizations gain deeper insights needed to make smarter decisions and drive better outcomes.
With Mareana Manufacturing Intelligence, companies looking to mitigate errors in compliance filing are able to:
- Digitize Paper Batch Records: Manufacturing Intelligence allows for the digitization of all paper records from internal and external sources – extracting data into usable formats.
- Unlock Siloed Data: With a single-pane view, companies achieve better collaboration between departments and streamlines data for regulatory compliance processes.
- Ensure Complete Reporting: Missing data or information often leads to filing challenges. With Manufacturing Intelligence, organizations can ensure all filings are complete for reporting requirements.
- Leverage All Data Source: Manufacturing Intelligence helps ensure all data sources are leveraged for total accuracy, regardless of internal or external sources.
Organizations can leverage Mareana Manufacturing Intelligence to bring together their compliance efforts into one unified strategy that all relevant team members can access. The benefits will impact everyone from frontline employees to chief compliance officers.
Simplify, automate, and reduce workloads across entire companies with Mareana Manufacturing Intelligence.