Tools for Maintaining an Audit-Ready State to Ensure Compliance

In the last three years, the U.S. Food and Drug Administration (FDA) issued more than 30 warning letters and 483 form inspectional observations related to electronic records. It appears the medtech industry is not sure how to comply with FDA inspection requirements. So how can the industry gain insight on this subject?

A regulated organization can benefit from automated compliance management solutions. These solutions include many different modules that work together or can stand alone. Users are able to leverage technology to keep processes and production in line, using automated tools such as document control, risk management, corrective action, etc. 

Many life sciences companies aim to reach and maintain compliance with regulations set forth by agencies such as the FDA. Automated solutions can help firms achieve these goals, tracking and tracing compliance from beginning to end, while enabling systematic and objective decisions to be made. 

Some of these automated compliance management solutions include:

Document Control
Data is constant. It’s always flowing, and without a method for putting everything in its respective home, organization is near impossible. Document control helps create document records, assign users keywords to records so they are easier to locate, and enables users to attach files and documents of any size or type to be routed through document review and approval phases.

This ensures that changes to documents follow change procedures and processes. Document control solutions offer traceability into processes and total control over compliance. One of the many obligations of life sciences companies is conforming to regulations like ISO 13485 and the FDA’s cGMP (current good manufacturing practice) requirements.

Employee Training
Information or standards that are changed within a document control system can be automatically routed through an employee training system. When updated, a record is sent through the employee training database for updating and re-training, thereby helping workers remain knowledgeable on all processes and responsibilities. Employee training offers automated tests to verify that training requirements are completed with a pass or fail grade. This helps not only to track the current status, but enables administrators to oversee what documents and elements may need more or future training to prevent potential adverse events.

Audit Management
Audit management is one of the most powerful automated solution modules. It enhances the user’s ability to see what is going on behind the scenes of processes. Manual audits can take months to complete but automated audit management software, checklists, and questionnaires can reduce this time span to mere minutes. A comprehensive audit report can be built for all audit types within a system. This means that profiles for each audit can be set up so the auditor would only have to change and update questions instead of manually searching for various types of information.

Multiple audits can be set up periodically throughout the year with the audit management system.

Risk Management
Risk management software tools allow users to handle adverse events systematically. The best way to take care of non-routine events is to identify trends in risk and take the initiative to mitigate the risk of a specific event and its recurrence. Risk management should be incorporated within all processes to ensure a high level of compliance. Risk templates allow employees to build a history of events and generate reports by various risks from all areas of business. This helps create a macro-level view of risk across all processes and enables decision-makers to take action to potentially prevent the risk before it’s too late. The ability to initiate improvement lies in risk management’s partner—corrective action.

Corrective Action
Corrective actions stem from the inherence of risk information and are automatically linked to the original assessment for clarification. This means that once an adverse event is detected through risk management, the software finds out all necessary information to put a stop to it. Once completed, corrective action software conducts investigations to find the root cause of an adverse event. The root cause allows the correction process to be truly remedial to the process. Corrective action solutions provide the ability to inherit data from an adverse event such as a complaint, audit, nonconformity, or any other type of event and escalate the process for each corrective action using an intuitive, rules-based workflow.

Complaint Handling
Complaint handling software manages the complete investigation and resolution of consumer complaints or events. It helps ensure compliance with FDA guidelines. Complaint handling software records all complaints from customers and ensures that companies issue a timely response. It also keeps a record of consumer and product data for future reference.

An important part of compliance stems from how a company handles complaints. Part of ensuring compliance is making sure that all complaints are recorded, reviewed, measured, and action is taken in a timely manner. Automation through complaint software ensures this is the standard and allows information to be transferred from one tool to the next. For example, complaint handling software allows users to launch corrective actions (if necessary) to determine risk levels and build a transparent view of post-market activities.

Reporting Tools
Reporting tools help create and maintain visibility into quality and compliance management. Fostering change within systems often stems from eliminating the guesswork. This can be accomplished through reporting.

Reporting templates show scheduled or ad-hoc reports with drill-down capabilities. This allows users to see the exact information they are seeking in real live graphs. This builds business intelligence and leaves nothing to chance. How a company is doing in its internal reporting may reflect on its performance overall.

Closing Thoughts
Generally speaking, fostering a state of audit-readiness can seem hectic but with integrated quality and compliance solutions, the process becomes standard. Driving regulatory compliance is critical to businesses. The FDA has placed significant oversight on the life science industry, so compliance is crucial to success. This oversight is leading companies to strive for transparency in compliance processes to increase functionality. Managing an audit-ready state will ensure the best possible outcome every time.

Compliance management software enables organizations to automate and simplify the compliance process. Automated software is built with traceability in mind so there is visibility into every step, and control toward ensuring the best possible outcome.  

Automated audit management software allows companies to perform better audits, faster. Arguably, audits are one of the most important parts of a quality manager’s job and also the most time consuming. Setting a system in place to do the dirty work like the creation of checklists for planning, scheduling, and performing simplifies the process. Using modern technology and shaping it to achieve specific goals will give life sciences companies the tools they need to achieve not just compliance but operational excellence.