Serialization

SAGE Engineering Services Ltd. provided Project Management and Equipment Engineering for the implementation of a Serialization solution to meet a regulatory compliance deadline to coincide with a new product launch. The scope of work included the design, procurement, testing, installation and qualification of a Manual Aggregation Workstation on a solid dose packaging line. After analyzing the client’s extensive product portfolio, SAGE provided Subject Matter Expert guidance on the latest regulations and best practices to develop Serialization Strategy and Project Plan.

SAGE prepared a detailed User Requirements Specification and assisted in the Procurement phase, including technical and commercial evaluation of all vendor bids. SAGE played an integral role in the design and review of packaging and inspection technology to complement the client’s existing processes. SAGE also managed the required changes to the facility and network architecture including installation of network ports, configuration of LDAP groups, and development of a Serialization Fileshare for batch variable data and EPCIS reports. Coordination and execution of FAT, installation, start-up, commissioning and qualification activities by SAGE ensured that the new product launch was successful.

SAGE collaborated with Manufacturing, Supply Chain, IT, and Engineering to deliver a Serialization solution that met all user, business, regulatory and quality requirements,on time and within budget.

Key Features:

  • Successful installation, commissioning and qualification of a Manual Aggregation Workstation to meet GS1 and 21 CFR Part 11 compliance.
  • Equipment interfacing with client’s IT network architecture for Serialization Data Management and EPCIS compliance.
  • Effective Project Management based on Equipment Project Life Cycle approach to meet a regulatory deadline.

Project Size:
Proprietary

Project Value:
$400K

Client Reference:
Available Upon Request

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