Need Help Implementing & Maintaining a Validated and Compliant Labeling Solution?

Look no further - Loftware offers a comprehensive enterprise solution that meets the needs of medical device and pharmaceutical manufacturers. Loftware recently announced that they have partnered with USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, to deliver the new Loftware Validation Accelerator Pack (VAP). The Loftware VAP enables customers to quickly and cost-effectively implement and maintain a validated and compliant labeling solution. 

This new solution which simplifies compliance, increases productivity and minimizes validation costs, complements Loftware Spectrum, the industry’s most powerful labeling solution designed to address the unique complexities and regulatory requirements of labeling in the pharmaceutical and medical device space. 

The Loftware VAP, which enables Loftware’s medical device customers to validate Loftware Spectrum to meet FDA and EU regulatory requirements, provides a standardized approach for ongoing validation. The Loftware VAP paired with Loftware Spectrum’s configurable workflow framework and eSignature capabilities provides a jump-start towards validation and helps to facilitate 21 CFR Part 11, underscoring Loftware’s ongoing commitment to medical device and pharmaceutical labeling.

USDM’s VAPs have proven to help companies meet the requirements of the FDA and other Regulatory Agency validation requirements for computer systems and equipment supporting regulated functions.

“The UDI Final Rule certainly resulted in medical device companies updating or implementing new systems and equipment that require validation,” stated Jay Crowley, Vice President of UDI Services and Solutions at USDM Life Sciences. “The Loftware Validation Accelerator Pack (VAP) helps these companies meet compliance requirements while reducing validation time and costs by up to 50%, achieving better efficiency and a competitive edge.”

Loftware and USDM developed the Loftware VAP to be comprehensive and include key components for validation and compliance in the medical device field:

• Validation Plan
• System Requirement Specifications
• Functional Risk Assessment
• Installation Qualification
• Operational Qualification
• Performance Qualification
• Traceability Matrix
• Validation Summary Report
• Vendor Audit Report
• 21 CFR 11 Assessment.

The package is a complete set of content rich validation templates that are ready to be configured to reflect each customer’s configuration decisions.

“Our partnership with USDM is a perfect complement to Loftware Spectrum which provides unrivaled capabilities for meeting the complexities of labeling in highly regulated industries,” stated Josh Roffman, Vice President Product Management at Loftware. “With the Loftware VAP, we’re able to further accelerate and streamline the validation process, providing an integrated and comprehensive labeling solution that simplifies compliance, increases productivity and minimizes validation costs,” he added.

For more information on Loftware's new VAP or our Enterprise Labeling Solutions contact Loftware's team of labeling experts today.

The Critical Challenges in Manufacturing Labeling

The amount of critical data required on a barcode label for products in today's Manufacturing Industry is far more complex than ever. To better understand the challenges facing the industry, Loftware polled a group of over 175 labeling professionals from around to globe. The infographic below was developed from the recent survey and represents some of those challenges. If you're interested in finding out more download Loftware's full Manufacturing Survey Report today.

Addressing Variability in Barcode Labeling

Labeling today is complex; companies are faced with a wide range of evolving requirements. They include regional, language, customer and regulatory requirements, which all must be met in a quick and efficient manner to avoid disruption to business and to companies supply chains. Companies that are not able to support these new requirements and streamline label changes to deal with this extensive variability can end up with fines, dissatisfied customers and loss of business. Enterprise Labeling allows businesses to deal with variability in labeling by enabling label formatting and content to change dynamically to support a myriad of different label combinations with a minimum number of label designs.

What Are the Major Drivers Causing Variability in Labeling?

There are a number of areas that cause variability in labeling, but the primary drivers are customer specific and regulatory requirements. There really is no standard label anymore that works for everybody. Customers are becoming more and more demanding about the labels that appear on goods and products they receive, distribute and sell. For instance, there may be a single standard product that works for everyone but the product label may vary greatly from customer to customer based on their unique requirements. Although it’s the same product, it could require the label have different data, images or other information to meet the customer specific needs – so customers are driving a vast amount of variability in labeling today.

Certainly regulatory is also driving variability, across a broad set of industries like chemicals, food and beverage, medical device, pharmaceuticals and many others. The location where a product is made and where a product is shipped is a factor that further complicates labeling and how compliance can be achieved as each country or region has specific versions of regulatory requirements. For example, health and safety information must be indicated in the language of the country the product is made and if it’s being shipped to another country then information must also be provided on the label in that country’s language. Also, depending on the product, there may be requirements for a compliance logo (such as the RoHS logo for electronic products). So it’s also possible that product itself can dictate variability in labeling.

How Can Variability Negatively Affect a Business?

Companies have to address variability one way or another; whether it’s in an automated fashion with their current labeling solution or through manual effort. When it comes to manual labeling companies need to either apply labels directly to each product to address the customer specific requirement or make sure that each product or variant of that product, in a regulatory case, has labels pre-built. This obviously involves a significant amount of time and effort.

So, the impact of variability is significant on a business. It can mean increased cost and it can mean a manual labor-intensive process, which can result in time to market problems when companies can’t deliver products fast enough or on time for their customers’ schedules. When it’s necessary to manage the process manually or to produce multiple label permutations, time becomes a factor and this ultimately can slow production and can mean delayed shipments, which can result in fines and dissatisfied customers. When variability isn’t addressed, products and shipments can be denied or even pulled from customs if they are not labeled correctly. Also, managing this type of extensive variability in a manual fashion can result in mislabeling, resulting in delays and fines.

How Can Implementing an Enterprise Labeling Solution Help a Company Manage Regulatory and Customer Requirements?

Having an Enterprise Labeling Solution means you are able to automate your labeling process and utilize business logic to deal with extensive variability. With this approach, business users can access the labeling solution to address any necessary changes without having to involve IT. They can deal directly with the customer to meet regulatory or customer specific transactions in a timely and less intensive way, using less technical resources. This approach is more cost effective with quicker time to market. When a company uses an Enterprise Labeling Solution, they can dynamically change label content so they can easily manage regional, language and any customer specific requirements. Any changes and updates can be made in hours or days rather than months so that deadlines can be met.

An Enterprise Labeling Solution also offers symbologies, tools, and integration to sources of regulatory data to make sure the needs of each customer is being met throughout each channel of a company’s supply chain. This type of centralized label management can help ensure that your labeling has consistency and that your company is adhering to regulatory guidelines throughout your company’s global supply chain. This approach also removes the threat of mislabeling.

How Can Configurable Business Logic Improve a Company’s Overall Responsiveness in Meeting Changing Labeling Requirements?

Having configurable business logic allows business users to address the changes or new requirements without having to go back and reprogram or change information in their corporate systems. They don’t have to do anything special because they already have all the information they need in their systems of record and they can just build or update rules in a rules engine. They can address any particular requirement in the labeling solution without having to impact other business systems and they can do it very quickly.

Configurable business logic also is critical in reducing the number of labels a company has to manage since dynamic changes can be made to templates rather than making new templates for every variation of label.

For more information on the benefits of the Enterprise Labeling model, check out this Special Report.