Digital Validation for Consumer-Packaged Goods: Challenges and Solutions

Discover how our innovative, automated, compliant digital validation solution, Kneat Gx, helps to alleviate validation challenges for world leading consumer-packaged goods companies, while creating new opportunities.

In the consumer-packaged goods (CPG) industry today, forward-thinking organizations are shifting from inefficient, manual, paper-based commissioning, qualification, and validation activities to more advanced, smart, cloud-based software-as-a-service (SaaS) industry tools and technologies. Kneat leverages specialized cloud automation processes —like infrastructure-as-code, immutable infrastructure and containerization—to enhance the delivery of our digital validation solution, Kneat Gx and provide an easier, faster, and more responsive validation service for all our customers.

Read this blog to discover how Kneat can help you to address common validation challenges that CPG companies face today and how you can create new opportunities for your validation teams and your business, as we spotlight:

✓  Packaging validation
✓  Cold chain validation
✓  Supplier qualification in C&Q
✓  Audit trails; and
✓  Process discord

Packaging validation

The challenge
Successfully designing, testing, and validating effective packaging that both protects consumer-packaged goods and maintains sterility when needed is a complex challenge. Slipups can lead to costly delays, product loss, recalls and risk to patient safety.

The solution
When product development, package design, and validation experts can collaborate early on in the process, it can also create additional opportunities to streamline all aspects of the go-to-market process. Kneat Gx allows you to collaborate and manage all your product’s life cycle, starting with requirements and critical process parameters, through to Validation Final Reports in one easy-to-use application. Documentation generation is simplified in Kneat Gx by pre-approved templates and dynamic data sharing, which reduces time required to generate a document and reduces the human errors by eliminating the need to transpose data between documents.

Cold chain validation

The challenge
There can be several challenges with shipments in cold chain logistics, from broken products or exposing products to incorrect temperatures during transit. Typical cold chain validation processes remain paper-based making them inefficient, labor intensive and susceptible to data integrity and compliance risks. Ensuring cold chain integrity, consumer safety (and the value of brands) is paramount for any cold storage facilities operations.

The solution
Kneat’s cold chain digital validation application ensures data visibility and enables online monitoring of the validated state of the cold chain network, reducing risk of product loss and giving product owners peace of mind that all transport is operating as it should, with the correct temperature control.

Supplier qualification in C&Q

The challenge
Supplier qualification can be onerous and present efficiency challenges for manufacturers in all regulated industries, particularly CPG where supplier volume is high.

CPG companies must ensure that suppliers:
•   comply with all applicable GMP requirements
•   follow a validation framework, including the use of validation plans and reports
•   maintain compliance throughout the life of a system providing a supplier product or service
•   and integrate life cycle activities into the CPG company’s quality management system (QMS)

Determining whether a supplier meets your quality requirements can be a lengthy process, particularly that process is performed on paper with geographically distanced suppliers. The integration of supplier life cycle activities into the customer company’s QMS also poses a longer-term drain on resources, with the ongoing routine exchange of paperwork for a state of validation to be maintained. The paper-based work process for supplier qualification can be onerous and prohibitive to the speed to market of a new product line or facility time consuming because it requires manual transposition of data from one document to another, the physical movement of the paper documents, limited access to document information and status, and the physical storage of the document during execution and final archival.

The solution
Kneat Gx digitizes the entire Commissioning and Qualification Validation life cycle, delivering compelling productivity, cycle-time, and compliance improvements. By digitizing the validation life cycle, a regulated company can impress the requirement for suppliers to utilize a digital validation platform and automate the exchange of required data, allowing customer and supplier to integrate life cycle activities with greater efficiency.

Pharmaceutical industry leaders Merck Sharp & Dohme Corp., (MSD), selected Kneat to digitize seven validation work processes, including Supplier Qualification, at twenty-seven sites across two divisions (Manufacturing and Research).

“Kneat has become one of the foundational systems in QMS and beyond…the site network wants to use Kneat for other needs…suddenly we started getting contacted by other process owners who wanted to use Kneat…”

– Global Executive Director, QMS Technology Transfer & Commercialization at Merck Sharp & Dohme, Inna Ben-Anat

Audit trails

The challenge
Managing multiple reviews of multiple files without a system in place can be onerous, confusing, and time consuming.

The solution
Kneat’s intuitive user interface enables you to create an audit trail of user activity, improving quality and compliance at each stage of the development, production, and packaging process. Kneat automatically generates an independent detailed, un-editable audit trail in real time. You can see any user action, correction or change with a corresponding timestamp, and a range of other particulars at the click of a mouse. Any audit trail can be filtered and re-ordered to pinpoint any desired information during audit.

Process discord

The challenge
Process discord is when inconsistent validation processes evolve over time, across one or multiple sites. An organization’s validation and quality assurance professionals can tend to tailor SOPs, templates, test-cases, and other validation documents to the changing needs of their own site’s equipment, facilities, systems, or processes, creating variations of the same process. Without standardization, variation is free to create risk which can ultimately impact consumer safety.

The solution
Using a fully paperless, automated, secure, cloud-based solution, like Kneat, that standardizes validation processes across multiple sites has many advantages. Processes are executable by staff interchangeably across sites, standards for data integrity are enforced, and colleagues working across different departments and locations can access a single source of truth in real-time.

Trusted digital validation that delivers

Paper-based validation inconsistencies and inefficiencies are arguably one of the biggest threats facing consumer-packaged goods companies today. The industry is changing fast and demands an innovative, compliant, digital validation solution that helps to deliver products to market more quickly, safely, and effectively than ever before.

Find out how we can help you to create new efficiencies in your validation processes, just like our Fortune 500 and Interbrand Best Brand clients did.

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