Contract Manufacturing Organization – Finished Goods Package Labeling System

The Challenge

A leading global CMO sought to implement a new package labeling system to replace an existing labeling system that no longer met their needs.  The existing system operated on an outdated operating system that was no longer supported by the OS manufacturer, lacked scalability, and was not compatible with a new ERP system.  This local solution would be implemented at only one US manufacturing location.

The labeling system was used to design and print packaging and shipping labels.

After successful completion of the local solution, the original client was acquired by a larger multinational CMO and a decision was made to provide a common Global Solution for labeling, both of these solutions are described below.

The PV Advantage

Performance Validation provided a dedicated team with a Project Leader experienced in managing Computer System Validation projects.  Formal, periodic status reports along with frequent customer interaction were employed to provide stakeholders timely information regarding project management elements such as costs, timeline, and scope control.  Modeled after ISPE’s GAMP 5, a risk based approach was executed to maximize quality and efficiency.  Performance Validation provided a validation strategy for the labeling system that met cGMP and ISO13485:2003 quality and compliance expectations.

The Local Labeling Solution

The local labeling solution involved the upgrade of an existing custom user interface application which interfaces with a legacy ERP, a database, and bar code label design and printing software.  Additionally the solution involved hardware platform and software upgrades.  The Validation Strategy for the local labeling solution included:

  • A GAMP5 Category 5 approach for the custom user interface.  A GAMP5 Category 4 approach for the commercial-off-the-shelf (COTS) (but configured) application. The IT infrastructure elements were evaluated as standard components.
  • An assessment of the vendor, system risks and complexity were completed and used to drive the level of testing.
  • Leading a team of stakeholders, Performance Validation facilitated a multifunctional group to develop the requirements and specifications of the project.
  • The Validation strategy & testing included:
    • Validation environments were used and production workstations were minimally used as to avoid interference with business operations.
    • The IT Infrastructure elements were subject to IQ.
    • The system platforms (several unique platforms due to the variety of label printer specific hardware configurations) were qualified, then the custom system was functionally (operationally or ‘OQ’) tested.
    • Performance Qualification (PQ) was focused on the intended use and workflows of the system.  Perhaps most importantly, the quality and accuracy of the printed labels was validated.
    • Summary Reporting provided stakeholders information on the success of the validation effort including results of testing and any critical deviations to be addressed.

The Global labeling Solution

The global labeling solution included a new configured user interface and the legacy database.  The user interface was designed through the bar code label design and printing software for interfacing with a parent company ERP.  Both projects also involved platform hardware and software upgrades.  The Validation Strategy for the Global labeling solution included:

  • A GAMP5 Category 4 approach for the commercial-off-the-shelf (COTS) (but configured) application. The IT infrastructure elements were evaluated as standard components.
  • Leading a team of stakeholders, Performance Validation facilitated a multifunctional group to develop the requirements and specifications of the project.
  • The Validation strategy & testing included:
    • The IT Infrastructure elements were subject to IQ.
    • Normally an OQ (Functional testing) would not be performed as the software functionality would be demonstrated through the audit of the vendors SDLC process.  However, an OQ was developed and executed to conform to the customer’s procedural requirements – yet a unique functional requirements document was not needed.  The OQ focused on User Requirements which were defined as functional in nature.
    • Performance Qualification (PQ) was focused on the intended use and workflows of the system.  Perhaps most importantly, the quality and accuracy of the printed labels was validated.
    • Summary Reporting provided stakeholders information on the success of the validation effort including results of testing and any critical deviations to be addressed.

The Results

  • Both labeling solutions were validated on-time and on budget to meet the customer’s overall implementation deadlines.
  • Testing of the local labeling solution identified several opportunities for efficiency improvement.  An example of these opportunities included auto population of fields, and reducing operator interaction with the User Interface.  Based on feedback from the client’s subject matter expert and system owner, identification and implementation of these solutions yielded a noticeable increase in system efficiencies.
  • Additionally, review of the local labeling solution identified opportunities to improve logical security which were addressed through implementation of additional logical and procedural controls.

The Benefits

The advantages of tailoring each validation effort based on system risks and complexity were realized.  Through complete and quality-driven validation planning, testing was minimized in both projects and the project team remained focused on the system’s intended use and defined critical quality attributes, such as the label output.  This ensured that timelines were met without sacrificing quality

Although the local labeling solution is no longer being used, thorough testing of the local solution identified opportunities for improvement in system efficiency and logical security.

With transition to the Global labeling solution, the medical device manufacturer now has a validated device package labeling system which meets their intended use, ERP-compatibility, and cGMPs / ISO 13485:2003 compliance needs, while allowing scalability and configuration to meet their growing business needs.

For additional information, contact:

Kevin Marcial, Validation Engineer
Performance Validation, LLC.
5168 Sprinkle Road
Portage, MI 49002
(269) 267-4020 Mobile