Adept Packaging Makes Serialization Programs Successful
Serialization & Technology Services
Serialization and Traceability are becoming increasingly prevalent in the Pharmaceutical, Medical Device and most recently, Food, Beverage and CPG industries. The main drivers, currently for Pharmaceutical companies are the global Serialization mandates and the strict timelines. However, compliance is not the only driver for Traceability. Across industries, companies are embracing Traceability for its value in securing the supply chain, reducing counterfeit and improving patient and consumer safety.
At Adept Packaging, we offer managed services for Serialization that encompass four major areas to ensure compliance with these regulations:
Training: Serialization and Traceability regulations impact almost all of Adept Packaging clients’ business processes. Adept Packaging offers training so clients can stay apprised of ever-changing regulations, learn the details of Serialization standards, and fully understand the impact of Serialization on their processes and systems. This training follows a modular, standardized, approach, which can be delivered with agility to ensure Adept Packaging clients are prepared to manage the significant investment in time and money to achieve compliance.
Strategy: Because of the pervasive nature of Serialization regulatory requirements, Adept Packaging has developed a proven, comprehensive strategy to drive compliance. Adept Packaging assists organizations with the development of a Serialization compliance strategy that encompasses objectives, resources, planning and optional business case opportunities.
Project Management: Serialization programs require effective coordination of internal and external resources in addition to hardware and software suppliers. Adept Packaging engineers and project managers provide the right combination of Serialization subject matter expertise and project management skills to ensure your investment in compliance is successful.
Implementation Support: Today’s healthcare companies are resource constrained. This impact to businesses is typically incremental to allocations and budgets. It can be costly to hire full-time Serialization specialists and such skills are hard to find in the market. Adept Packaging engineers are experts in all aspects of Serialization from assessment and architecture through the implementation of Serialization on the packaging line, including installation qualification and post-implementation support.
Serialization & Technology Expertise
Adept Packaging has strong experience in specialized areas within Serialization including the following:
Packaging Line Automation: The Adept Packaging Serialization team is comprised of Packaging Engineers with a rich background in packaging line automation, as well as a well-rounded experience in the pharmaceutical, medical device and other business sectors.
Hardware &Software: One of Adept Packaging’s core competencies is in the design, architecture, installation and management of hardware and software solutions necessary for Serialization compliance. Clients choose Adept Packaging because of our engineers’ technical acumen and experience across various solutions..
External Supply and CMO Management: A majority of global manufacturers leverage external supply and contract manufacturing organizations (CMOs) for their pharmaceutical manufacturing, packaging and distribution. Adept Packaging has worked extensively with CMO organizations on behalf of the Pharmaceutical company and directly on behalf of the CMOs, to ensure Serialization readiness for their pharmaceutical clients.
Automatic Identification and Data Capture (AIDC): 2D DataMatrix and Linear Bar Coding (Automatic Identification and Data Capture) require specific expertise to ensure right first-time application and use. Adept Packaging engineers are experts in GS1 standards and HDA requirements for 2D DataMatrix and Linear Bar Coding. Adept Packaging engineers are skilled in all aspects of AIDC concepts necessary for Serialization compliance.
Regulatory Requirements: Those who have followed the Serialization and traceability regulatory landscape know that this can be a very challenging aspect for businesses. Adept Packaging engineers and project managers are briefed on all of the emerging regulations that require coding and identification pertaining to Serialization.