Mistakes are inevitable. That’s not an excuse; it’s a fact of doing business. Unfortunately, in the life sciences and general manufacturing industries, mistakes can result in more than disgruntled customers and a barrage of complaints; they can result in serious safety issues, even death. With stakes this high, many regulated companies are automating their paper-based customer complaint management systems with electronic customer complaints management software to manage their complaint resolution process and maintain FDA and ISO compliance.
Customer Complaint Management Software and Its Role in Regulatory Compliance
Having an effective customer complaints management system in place is a matter of good business practice for any company. Quick and efficient complaint handling can reduce shipments of nonconforming products, lower labor costs, and reduce plant downtime. However, in FDA and ISO environments, where quality is foremost, complaint handling has deeper implications. Customer complaints alert the FDA and other global regulatory agencies to potentially life threatening product nonconformances. These nonconformances can be better managed by implementing an automated customer complaint management software solution.
Regulated industries, including medical device and drugs and biologics, are required to report any complaints that come through their customer complaint management system concerning death, serious injury, or adverse reaction. Some FDA regulations, such as 21 CFR Part 820.198 and 21 CFR Part 606.170, even require a formal complaint-handling process. Customer complaints management software can facilitate this process.
Complaints are also critical to ISO-certified companies. Although ISO compliance is largely voluntary, several standards have been adopted by some countries as part of their regulatory framework or have become a market requirement. The ISO 9000 series of quality management standards is a good example of an ISO standard that has become a customer or market requirement. Having an effective customer complaints management system in place, one that includes a robust customer complaint management software solution, can help regulated manufacturers maintain ISO compliance.
How Customer Complaints Management Software Meets the Challenges of Complaint Resolution
While the importance of a well designed customer complaint management system in attaining regulatory compliance is irrefutable, implementing one isn’t easy. When you consider the challenges associated with complaint handling, it’s hard to imagine how a company could hope to resolve complaints quickly and efficiently without a customer complaint management software solution. Some of the challenges include:
Disparate Complaint Gathering: Customer complaints come from a wide variety of sources: phone, email, sales reps, internal employees, and social media. If your customer complaint management system is paper-based and lacks a standard procedure for capturing or processing complaints, it’s highly likely that complaints will fall through the cracks, essentially not making it from someone’s email or voicemail into the resolution process. In today’s social media age, allowing customer complaints to languish on Twitter or Facebook in front of millions of consumers can cause serious, perhaps even irreversible, reputation and brand damage. Automating your homegrown or manual customer complaints management system with an electronic customer complaints management software system can not only better protect your customers, but also protect your company’s reputation and bottom line.
Detached Processes: Customer complaint management is a complex process, requiring an enterprise-wide commitment and a unified approach. Unfortunately, many regulated companies, particularly those that rely on a paper-based system rather than an electronic customer complaint management software system, utilize a variety of tools to track and follow up on quality events and complaints. Because of the many sources that feed into the customer complaint management system, this disparate approach compromises collaboration, which can lead to increased error or worse, lost complaints. Automating your complaint management and resolution procedures with an integrated customer complaint management software tool such as MasterControl Customer Complaints™ can help you standardize these processes and correct problems expeditiously.
Lack of Efficiency: Both of the above mentioned challenges lead to what is perhaps the biggest challenge to any customer complaints management system: inefficiency. Multiple gathering sources coupled with disconnected processes make it almost impossible for any regulated organization to resolve complaints sufficiently using a paper-based or partially electronic complaint-handling system. Manual systems are plagued by bottlenecks: lost or overlooked complaints, incomplete information, inadequate response time or no response at all. MasterControl’s customer complaints management software can help your organization achieve efficiency through automation.
Features and Benefits of MasterControl’s Customer Complaint Management Software
MasterControl Customer Complaints™, an integrated part of the MasterControl quality management suite, allows you to create a unified, closed-loop customer complaint management system for tracking complaints across processes, departments, and geographical locations. By automating all complaint-related tasks, such as data collection, notification, follow-up, and escalation, MasterControl’s customer complaint management software makes it easier to comply with rigorous regulations from the FDA, EMA, and other regulatory agencies, as well as stringent ISO standards. Here are just a few of the many advantages gained by implementing MasterControl Customer Complaints:
Improved Documentation: Using a pre-configured, multi-page electronic form that ensures accurate complaint data capture, the solution streamlines the documentation portion of your customer complaints management system into a simple three-step process: complaint processing, complaint investigation, and finally, complaint resolution. Every step of the process is automated and documented.
Advanced Reporting Capabilities: MasterControl’s customer complaints management software solution offers advanced analytics and reporting tools to allow for increased management oversight; this increased transparency improves decision making throughout the customer complaint management system. MasterControl Customer Complaints includes the following customizable reports: complaint summary; complaints categorized by type, product, and department; in-process complaints; and trending categorized by complaint type, product, and department. The solution also includes the FDA’s MedWatch 3500A form for mandatory reporting of adverse events.
Corrective Action and Preventive Action (CAPA) Integration: The overall effort to investigate and streamline quality events is the foundation of any customer complaints management system. MasterControl CAPA™ is an easy-to-use software solution designed to automate and effectively manage all activities associated with the CAPA process, such as triggering events, performing root cause analysis, and assigning the necessary follow up action—all while integrating CAPA with other quality processes, such as change control and audit. Seamless integration is what sets MasterControl’s customer complaint management software apart from other solutions.
Continuous Compliance: Continuous compliance is, or should be, the quality goal of all regulated manufacturers regardless of industry. To achieve this, every complaint that comes through the customer complaint management system must be properly evaluated, thoroughly investigated, and sufficiently corrected. MasterControl will not only help you attain compliance with the FDA, ISO, and other regulatory agencies, but also help you sustain that level of compliance over the long haul.
Industry Customization: MasterControl offers a customer complaints management software solution customized for the medical device industry, MasterControl Customer Complaints MD™, as well as a solution designed for the pharmaceutical industry, MasterControl Customer Complaints Pharma™.
For More Information on Customer Complaint Management Software Systems
MasterControl Inc., a global provider of quality management software solutions and services, today announced that the company and its partner, i4DM, will continue their roles as the quality management system providers for the U.S. FDA's Office of Regulatory Affairs (ORA).
Software Magazine ranks MasterControl 369 on its 2014 Software 500 list, a listing of the world's largest software and services providers. Now in its 32nd year, the Software 500 is a revenue-based ranking of vendor viability. Learn More