Serialization and traceability within the life sciences industry have been around since the early 2000s. However, in order to reduce complexities, counterfeiting, and theft, efforts are being made this year to focus on serialization, tracking, and tracing to meet regulatory mandates.

Manufacturers are now expected to serialize products from the top of the supply chain all the way to the bottom. Since regulatory compliance has always been a top priority in this industry, the change in focus will also provide industry professionals with an opportunity to visualize the process clearly, and with the correct approach.

Implementing serialization technologies with help from automated software is one way to ensure visibility and control within the supply chain.

An automated Quality Management System (QMS) ensures communication throughout the product lifecycle. Companies can then manage and track product data easily with in-depth traceability offerings from manufacturer to distributor.

Larger businesses require a variety of tactics to tackle supply chain risks head on. Some of those tactics involve increasing resources through a QMS to better understand supply chain regulatory compliance.

Automated tools and technologies help deliver time and cost savings while enhancing overall value. This has been something larger life sciences companies have embraced, creating global networks.

Managing global supply chains is key to developing and expanding the global market share with product development and acquisitions, while keeping suppliers on track. Quality management software is the tool helping large companies remain competitive in regulatory industries and as of now, is something small- to medium-sized companies must begin to focus on.

Automated quality management software with external and internal configurable functionality can provide the digital technology necessary to improve product serialization. With certain automated modules, setting disciplinary actions and controls with third-party organizations is simplified.
Some solutions that remain helpful within QMS are:

Supplier Management
Many life science organizations already turn to outsourcing as a method to get products to market faster. However, with heavier controls set than before, meeting compliance obligations must be demonstrated as acceptable throughout the entire process. Any negative deviation or quality event can have a negative impact on the journey to market.

Supplier quality management allows users to maintain a high level of visibility and control. It ensures companies maintain a high level of compliance with suppliers by tracking receipt of accepted materials with set inspection business rules, building measurement activities dependent on past supplier performance, automatically feeding supplier activities into a comprehensive rating report, and collecting quantitative and qualitative supplier rating information.

Mitigating supplier risks lies in the ability to build risk capabilities into supplier processes. It also helps provide a more objective means of assessment while showing actions taken in a holistic report, so if defects are found, companies are made aware and can identify trends before an adverse event takes place.

Risk Management
Risk tools can be applied throughout the supplier management process, adding a level of dimension to inspection and monitoring. Risk-based supplier reporting and the overall mitigation of supplier risk share the goal of giving organizations a repeatable means of selecting suppliers that pose the least amount of threat to a business.

While risk tools help put threats into perspective, they also enable companies to set scorecards that contain a visual representation of qualitative and quantitative elements. From there, supplier-rated data on materials can be inspected, and if defects are found, companies can set controls to remain on the appropriate path to supply chain excellence.

Employee Training
Comprehensive training creates a strong foundation for employees. The life sciences industry is extremely fast-paced and involves many people and moving parts; good training ensures everyone is well-versed in their subjects of responsibility and processes.

Linking training to events allows companies to organize events by type. Understanding whether the training is quality- or safety-based assures groups they are receiving relevant and proper training, which avoids potential mishaps and wasted time.

It is possible to alleviate work stress with training. By allowing workers the opportunity to uncover systemic issues with visibility and control in a training environment, they have the means to avoid unwelcomed surprises and the ability to handle the adverse event as quickly as possible. In fact, the proper tools ensure companies the ability through reporting to refer to past events and training documents that will help pinpoint the situation and handle it with efficiency and genuine comprehension.

Audit Management
Audit management helps create visibility while maintaining global compliance initiatives. There are many concerns that come with outsourcing. For example, collecting product and regulatory information from raw material suppliers, analyzing it, and determining the necessary level of compliance in a timely manner.

Audit management software speeds up the process by building a supplier management profile as well as a material profile. From there, material codes are created and used to identify which suppliers have which goods. This allows for traceability and greater safety initiatives.

An automated system creates a centralized repository for information and audit requirements. It allows employees to quickly fill out custom questionnaires for each supplier, and takes it one step further by enabling scheduling with multiple individuals.

Audit planning allows companies to focus on certain areas. With the ability to view specific issues, administrators can determine where to focus their direction. It eliminates the need for managing excel spreadsheets and lengthy email chains to find appropriate data. This allows quality to become a team effort, as users can see each update and where quality strays.

Rather than relying on the sole responsibility of one party, audit management requires each user to stay on task, holding all accountable for their own part in compliance. A transparent supply chain is the most effective way to verify supplier compliance. It protects consumers as well as the company, and verifies that each product has proper documentation down the line.

The key to success—especially within a regulated environment—is incorporating visibility and control into various areas that will benefit the quality of products. This not only includes standardized compliance between divisions, but also across enterprises.

Getting compliance right the first time with appropriate tools helps resolve any supplier quality event with clear visibility and control. Controlling data in a centralized environment allows users to remain in constant communication to deliver hands-on quality throughout the supply chain process.

Working within the QMS provides users with real-time data within a secure platform. The stakeholder will still control their own data and suppliers are able to operate within the same environment, seeing only those aspects into which they are permitted visibility. Automated software solutions provide this level of security, which is beneficial when serializing products.

Visibility into supplier materials, compliance levels, and products for global operations is very important for regulated industries. With the right tools, companies can increase visibility, coinciding with updated industry changes while maintaining and strengthening good supplier relationships.

Reducing quality issues due to poor communication, while benefitting the bottom line (getting the product to market) is the main goal so that consumers are receiving safe and quality products. Quality management software automates processes that not only identify unwarranted events, but extends controls to alleviate and mitigate them along the way. 

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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