Client Overview
A global pharmaceutical and biotechnology leader has partnered with ManageArtworks since 2014 to manage and streamline its packaging artwork operations. Over the years, the company has relied on the ManageArtworks Artwork Management Suite (AMS) and Proofing tools to centralize workflows, improve visibility, and ensure compliance across regulated markets.
By centralizing workflows, version control, and stakeholder reviews into one system, ManageArtworks has helped the organization shorten approval cycles, improve visibility across teams, and ensure packaging accuracy across regulated markets.
To further simplify and accelerate internal operations, the company initiated a change request to simplify a complicated multi-step workflow while ensuring full validation and documentation in line with pharmaceutical standards.
The Challenge
- Implementing changes in a validated pharmaceutical environment is never simple. Every modification, even process optimization, must go through a rigorous cycle of documentation, testing, and qualification.
- For this project, the estimated time to complete all required phases — implementation, UAT support and training, QC testing and bug fixing, technical documentation, and validation — was 2 months.
- However, the organization needed the changes implemented within a couple of weeks to align with other ongoing system activities and avoid operational bottlenecks.
- The challenge for ManageArtworks was to deliver a fully validated workflow transformation within a strict timeline, without compromising compliance or audit readiness.
The Execution
The ManageArtworks team followed a structured and collaborative plan aligned with the client’s validation framework. The execution involved key phases including FRS preparation, impact assessment, configuration specification, IQ and PIQ execution, OQ execution, and PQ, each carefully managed to ensure the workflow simplification met stringent pharmaceutical compliance standards.
To enable close coordination and faster decision-making during critical phases, a dedicated execution “war room” was set up at the ManageArtworks office. Senior stakeholders from both the client team and ManageArtworks worked side by side for extended hours, allowing real-time issue resolution, quicker approvals, and tighter alignment across validation activities.
Throughout the process, both teams maintained daily checkpoints, transparent documentation, and continuous traceability, ensuring every step remained compliant, controlled, and audit-ready.
The Results
The change request was executed and validated in record time.
- All deliverables were completed in alignment with the client’s internal validation and documentation standards.
- The approval process was streamlined and simplified, improving efficiency without compromising traceability.
- No interruption to ongoing artwork operations or existing system functions.
- Daily coordination and rapid feedback loops ensured timely validation and sign-offs.
The initiative achieved its goal of simplifying operations while upholding validation standards, reinforcing an efficient and compliant framework for future process improvements.
.webp)
