Packaging

Schawk Digital Solutions Makes Its Pharma-Grade Software Validation Package Available to Food and Beverage Industry

Monday 21. September 2009 - Designed to Mitigate Risk Surrounding Growing Food Safety Regulation

Schawk, Inc. (NYSE: SGK), a leading provider of brand point management services enabling companies of all sizes to connect their brands with consumers to create deeper brand affinity, announced today that it is making its pharma-grade software validation package available to the food and beverage industry.
This comprehensive software validation package, which allows for the controlled implementation of Schawk’s BLUE software has been designed to meet the highest levels of quality management standards within highly regulated and validated environments. Schawk has been delivering fully configurable, comprehensive software and validation service solutions to seven pharmaceutical and medical device companies worldwide since 2002. As Schawk has been helping the pharmaceutical and life sciences industry mitigate risks associated with mis-labeling, documentation and traceability, it can help consumer products companies mitigate similar risks surrounding growing food safety regulation.
Alex Sarkisian, chief operating officer, stated, “In a global economy where ingredients may be sourced in one part of the world for products manufactured and packaged in another part of the world, food safety must be viewed through a global prism. All consumer products companies — especially food and beverage companies — will have a greater obligation to comply with growing regulatory oversight, inspections and audits to trace the source and distribution of products from source to shelf.”
According to David A. Schawk, president and chief executive officer, “Schawk’s experience delivering validated solutions to the rigorously regulated pharmaceutical and life sciences industry can be leveraged by food and beverage companies to get ahead of the legislative curve, as opposed to reacting under pressure to required compliance measures. These measures could occur with more frequent inspections as a result of the recent passage of H.R. 2749, the Food Safety Enhancement Act of 2009.”
Schawk’s software validation package is supported by strict quality management standards. Schawk Digital Solutions adheres to predefined System Implementation Life Cycle (SILC) procedures which allow for the controlled implementation of its BLUE software. Each SILC procedure lays out step by step, the requirements necessary to plan, design, build, test, train and deploy a BLUE system, and articulates the outputs and deliverables for each stage.
Stephen Kaufman, chief technology officer, commented, “Schawk’s validation package is designed to help clients efficiently achieve compliance while working within their internal standard operating procedures to satisfy compliance with both internal policies and FDA guidance documentation requirements. If a company is already using Schawk’s BLUE software, like many food and beverage companies are, they are already ahead of the game. Our quality management documentation for non-validated environments is exceptionally strong, permitting an easy transition to a validated environment for most companies.”
The Schawk validation package consists of detailed templates containing SILC information that may be used by food and beverage companies to produce the documents required by the U.S. Food and Drug Administration (FDA). These templates have been created against validation industry guidelines and include various key validation planning and reporting documents, requirements and design documents and qualification protocols.
The implementation of BLUE within a highly regulated, validated environment also enables companies to comply with Title 21 CFR Part 11 of the Code of Federal Regulations which encompasses the U.S. FDA’s guidelines on electronic records and electronic signatures in the U.S.. CFR Part 11 defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. It also requires drug makers, medical device manufacturers, biotech companies and other FDA-regulated industries to implement controls, including audits, system validations, audit trails, electronic signatures and documentation for software and systems involved in processing electronic data as required by FDA regulation.
Additionally, Schawk is accustomed to working within the regulations required of a cGMP-compliant (current Good manufacturing Practices) environment and is a certified supplier to clients working within this environment. This certification provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. When adequately put into practice, GMPs help to prevent instances of contamination, mix-ups, deviations, failures, and errors related to the manufacture and labeling of products.
Because packaging and labeling falls under FDA guidelines, quality auditors use FDA guidelines on manufacturing to inspect the facilities of their certified suppliers. As part of comprehensive, routine inspections, quality auditors inspect Schawk’s processes surrounding the intake, application, documentation, change management and tracking of information related to labeling and packaging. Some of the checkpoints that these auditors inspect relate to making sure the instructions on labeling/packaging are easy to read, the dosage instructions are correct, the content of the product matches the ingredients on the label and the size of packaging is correct based on the dosage.
BLUE is Schawk’s proprietary enterprise brand management software developed specifically to guide the lifecycle processes of the packaging and promotional materials developed to market, promote and deliver brand experiences. Schawk supplements its brand management technology with consulting, installation, training and maintenance and can provide on-site manpower when required. BLUE is comprised of five web-accessible modules that encompass digital asset management, copy management, workflow management, online proofing (which includes annotation and comparator tools) and Key Performance Indicators, or KPI, reporting. These integrate seamlessly together and with company-wide Enterprise Resource Planning (ERP) systems, and can be responsive to the complexities and unique requirements that regulate packaging in ways that broad-based ERP systems do not. BLUE is part of Schawk’s brand point management offering. Schawk helps companies create compelling and consistent brand experiences by providing integrated strategic, creative and executional services across brand touchpoints at home, on the go, at the store and on the shelf.