The Importance of an Integrated QMS Within Regulatory Industries

The life sciences market is constantly evolving, and automated quality and compliance solutions must follow suit. The ability to interact, collaborate, and coordinate across the board is key to uncovering gaps in processes and creates visibility between operational areas. Adopting a harmonized process with an automated Quality Management System (QMS) will enable users to assess risks and standardize processes while keeping up with regulations.

Regulatory agencies require companies to validate any software used in design, manufacture, packaging, labeling, storage, installation, and servicing of finished devices. Meeting such requirements is not always enforceable, but if companies choose to wait, regulatory agencies may issue a final guidance prompting companies to identify high risk or new items that must be reviewed externally. (This can result in fines or recalls.)

The QMS validation and change control helps create and report on a complete company overview by making sense of data before penalization occurs. Most life sciences organizations have an immense amount of data to manage—without means to easily access and interpret this data, it becomes difficult to spot trends across the organization. Further, industry focus on data analytics is a growing concept for many industries and expected to expand by roughly 25 percent annually through 2020. However, more than half of companies have reported they operate in a state of quality management disconnect.¹

Life sciences companies should break down silos by integrating QMS data with applications and systems that help build a competitive edge by improving safety, products, and processes. Manual systems do not offer the functionality necessary to effectively manage daily processes. Automated software allows users to manage and track data without wasting time and missing due dates.

Keeping Necessary Parties Involved
QMS integration allows companies to report on trends and real time updates. This involves all users and reduces time spent finding, filtering, and improving processes. Enabling transparency and breaking down silos of communication keeps all departments relevant and clued in on all procedures. Exceptions are identified and high-risk issues are seamlessly escalated, utilizing business process rules created from process experts’ knowledge.

Employees and suppliers must communicate to evolve. Integration within the QMS allows easier risk factor identification and fosters greater collaboration and visibility to increase end-to-end traceability.

In the era of big data, it is easier to see there is more information out there than ever before. It’s also easy to notice the necessity for process and product improvement—especially in the life sciences industry. Life sciences companies are often involved in creating groundbreaking technology like medical devices and pharmaceuticals, where safety is of the utmost importance.

As the market skyrockets, companies must become more sophisticated with big data to maintain quality and safety. In doing so, it is important to understand how integrating the QMS with intelligence tools will assist companies.

In pharmaceutical and medical device companies, quality and safety are equally important. A major way companies begin to make the quality-safety connection is quality systems integration and a centralized focus on health, safety, environment, and quality. Tracking processes that impact these factors is the most effective way to notice change, nonconformances, and service potential adverse events.

Investing in technology helps streamline the process. It’s about connecting suppliers, employees, and consumers to our systems and building a way to create a secure, two-way collaboration to empower data. Gaining visibility and control over processes with a seamless link from event detection to event correction across the supply chain allows a company to build a quality network.

Benefits of Integrating QMS
Integrating the QMS with other business tools allows users to take in and understand volumes of data to advance changes. Modeling, forecasting, and data visualization are key in creating a safe and controlled product.

By integrating tools such as risk management, corrective action, and audit management, companies are able to bring products to market more quickly with reduced risks. Optimizing supply chain management is also helpful to manage a complex landscape of suppliers or contract manufacturers, as it allows companies to stay ahead by ensuring the market is getting what it wants. This is facilitated when suppliers leverage and share an OEM’s quality processes.

Research has shown the QMS dramatically transforms operations and results in best practices. However, it begins with the selection of a solution that is right for achieving company goals.

In the life sciences industry, generating actionable insights is a commonly shared goal. With constant data influx, companies must understand how to break down silos and tell important information apart from the rest.

By bringing together information from disparate sources, data is considered more compound. One of the downfalls of bringing a product to market faster often is the level of disconnect between post-market feedback and product design.

1. Document Control
Auditors expect to see documented information that demonstrates validation. Document control spans several phases and creates records/reports that provide transparency. The steps involved are planning, specification, test planning, testing, and review.

Once these are completed, document control can combine all documents into one report for audit-readiness. A document control system ensures documents are kept up to date, controlled, and provide a comprehensive history of changes. It lets users effectively automate and route documents from review to approval, and through distribution.

Integrating document control with other processes, jobs, and specifications puts control in users’ hands. This is effective as any changes made will automatically be reflected in the office file to maintain consistency for all users in real-time.

Using a quality system to drive the document control process provides companies with a total solution for managing change from request to approval to publishing and training on all documents.

2. Risk Management
Increasing market shares in the life sciences industry requires the ability to bring products to market faster than competitors, while balancing risks to consumers. Ultimately, the best way to reduce risk is in the design phase. Many companies today will use QMS solutions integrated with risk management tools to help manage risk throughout research and development. Use risk as a metric to track and trend adverse event records, identify regulatory gaps and audit findings, and evaluate supplier risk.

Breaking down data silos is a key part of the continuous improvement process, not an event. It requires the right commitment and resources to improve performance through data integration. Risk management tools integrated with then QMS helps promote long-term value within a company by identifying and closing compliance gaps (regulatory, product quality, process, etc.). If a company can see where many problems stem from, they are able to be avoided once and for all.

3. Corrective Action
Corrective action offers the proper tools to break cycles of risk and introduce change. The rule of corrective actions is they should be a one-time deal.
Corrective action should mitigate risks and use closed-loop tools to filter and foster efficient resolution. They are most effective when systematic. If there is a plan set in motion, users can save time and resources by handling issues appropriately the first time around, so there is more time to focus on the rest of the organization.

Closed-loop corrective actions follow the following steps: investigation of root cause, creating and launching an action plan, resolving the issue, and verifying the effectiveness of the corrective action. Using this process within the QMS will eliminate repeat offenses of the same issue, which fosters overall improvement.

4. Supplier Management
Suppliers and contract manufacturers play an integral role in creating quality products. Therefore, it is important to recognize the value of integrating the QMS with supplier management.

Integration of the QMS and supplier management introduces visibility. It allows users to pinpoint the location and movement of products, track the source and cost of problems all while monitoring supplier corrective actions. This allows suppliers and contract manufacturers to understand and manage supply chain risk that could potentially lead to recall. Risk and supplier management is present from design to implementation to post market feedback. Supplier management tools provide the ability to:

• Use supplier ratings and scorecards to benchmark contract manufacturers, incorporating risk assessment to pinpoint the most likely source of future problems.
• Assign corrective actions to external parties, making it easier to track resolution of issues while placing the responsibility on suppliers to make improvements.
• Quickly trace the source of problems originating outside the company, linking them to other quality functions like customer complaints and nonconformities.

5. Audit Readiness
Regulated organizations that maintain a state of audit readiness are able to provide internal or external data to the auditor within a moment’s notice. Audit management built with traceability of events in mind allows users to demonstrate quality and compliance within any adverse event or audit and display a report of root cause and actions taken, along with the effectiveness of each approach and verification.

Audit readiness supplies users with automatic scheduling, convergence of quality and safety, mobility within audits, keyword based templates, integration with all other tools, and continuous improvement opportunities.

Automating the QMS with other tools is extremely beneficial, as data is critical to the life sciences industry. Along with fluent guidance, companies who adhere to regulatory agencies have effective document control, allowing users to remain aligned with company goals and better audit trails for test procedures, updated processes, and necessary equipment for maintenance records and risk controls. 

U.S. Food and Drug Administration enforcement of GMP regulations is a growing concept and results in hundreds of observations and warning letters received each year. Companies are experiencing expensive and time-consuming remedial action. The best method to avoid costly and timely remedies is to plan ahead and practice good record-keeping procedures throughout each year, which will enable a constant state of audit-readiness. 

Reference

1. bit.ly/odt051701

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Emily Ysaguirre is a writer for VERSE Solutions, a cloud-based compliance management software solution that helps automate the processes surrounding quality, compliance, and environmental health and safety. Learn more about VERSE by visiting www.versesolutions.com or blog.versesolutions.com.