From “A Trial Run” to “Proactive Expansion”: A Real-World QMS Implementation Journey for a Vaccine Manufacturer

One year ago, our client launched the first phase of their QMS simply to test the waters. Today, the second phase is nearing launch, and the third phase is already in progress. We’d like to share how we built solid trust step by step along this journey.

Client Profile

This biotech company specializes in protein structure design and viral vector vaccine development, with its products fully commercialized and certified with Indonesia’s Halal standard.

As business expanded rapidly, the enterprise prioritized the digital transformation of quality management:

• Change control involved cross-departmental workflows with excessive handoffs, calling for higher operational efficiency.
• Deviation and CAPA records were scattered across disparate forms, creating a need for centralized storage and quick retrieval.
• The company aimed to shift from manual quality process tracking to system-driven management, laying a robust data foundation for future regulatory audits.

Phase 1: Breaking the Ice (6-month Implementation)

The first phase focused on rolling out three core modules: Deviations, Change Control and CAPA.

Instead of jumping straight into system configuration right after kickoff, we spent two weeks streamlining existing workflows. We conducted one-on-one interviews with teams across QA, Production and QC Laboratories to map out real-life deviation handling and change approval processes, and pinpoint operational bottlenecks. We then delivered visualized workflow diagrams for client review. Unlike lengthy technical requirement documents, these diagrams enabled the client’s leadership to review processes intuitively, raise revisions on the spot and cut down rework significantly.

The configuration and testing stage was challenging, given the tight testing timeline and the heavy daily workload of on-site business teams. We coordinated with client department heads to arrange dedicated time for business administrators to conduct joint testing, ensuring all workflows and role-based operations functioned properly.

Our training went beyond basic button navigation. We elaborated on the logic behind every operation: the rationale for approval nodes, mandatory fields and record associations. We also recorded step-by-step tutorial videos for on-demand review, which the client later deemed far more practical than standard training slides.

Prior to go-live, we completed comprehensive functional testing and User Acceptance Testing (UAT). Test cases covered mainstream workflows, exception scenarios and edge cases, with every test performed and verified jointly by both teams rather than solely by IT staff. All identified issues were documented and resolved in a timely manner to guarantee a fully operational system.

Results six months post-launch:

• Average review turnaround for quality processes: reduced to 3 working days
• Cross-department collaboration efficiency: fully completed within 2 working days
• Audit preparation efficiency: quality ledgers and module records retrievable in just 5 minutes

Shortly after Phase 1 went live, the client proactively initiated discussions for Phase 2.

Phase 2: Proactive Expansion (Ongoing, Launch in 1 Month)

Building on the trust established in Phase 1, the client decided to expand the QMS scope with three new modules: Supplier Management, Out-of-Specification (OOS) Management and Audit Management.

We did not simply follow the client’s basic requests. Instead, we conducted a full review of the system’s six-month operation to identify areas for further digital optimization. Centralized supplier qualification management, standardized OOS investigation workflows and closed-loop tracking for audit findings emerged as the key priorities, which perfectly aligned with the client’s actual demands.

The biggest challenge of this phase lay in cross-module integration:

• Over 100 sets of supplier data were cleaned up and interconnected with the existing Change Control module.
• A three-stage (Phase I/II/III) structured workflow was designed for OOS investigations with mandatory deadlines to prevent prolonged inquiries, and mandatory explanations were required for overdue cases.
• Audit findings were configured to automatically trigger CAPA processes, which required adjustments to the original trigger logic from Phase 1.

Thanks to the flexible configuration capabilities of the Akso platform, all cross-module linkage rules were set up via visual configuration instead of custom development. Reserved extension interfaces from Phase 1 also ensured smooth upgrades without disrupting existing systems.

Currently, system configuration and functional testing have been finished, and the project is in the final validation stage, scheduled for official launch in one month. Early trial data shows the average OOS investigation cycle has been shortened from 45 days to 22 days, and supplier qualification management has achieved full digitalization.

Phase 3: Officially Initiated

Even before Phase 2 concluded, the client moved forward to launch Phase 3, focusing on the Validation Management module.

With growing commercial production scale, equipment validation has become increasingly complex and labor-intensive. The client expects to implement full lifecycle management for IQ/OQ/PQ, automatic reminders for revalidation plans, and deep integration with Change Control and CAPA.

The Phase 3 design includes:

• End-to-end IQ/OQ/PQ lifecycle management
• Automated revalidation scheduling and alerts
• Seamless linkage with Change Control and CAPA: the system automatically triggers workflows for all validation-related action items; no equipment change can be closed until relevant validation plans are approved.

The core objective is to transform validation from a passive compliance task into a proactive risk management tool.

What Made This Project a Success?

The continuous expansion across three phases stems from our proven implementation methodology and the robust capabilities of the Akso platform. Below are our key differentiators compared with common industry practices:

1. A Unified Integrated Platform, Not Disjointed Modules Many QMS solutions in the market are pieced together from separate systems, where deviations, document management and CAPA run on standalone platforms. This creates data silos and high interface maintenance costs. As a native unified platform, Akso supports all modules — Deviations, Change Control, CAPA, Supplier Management, Audit and Validation — on one single data architecture. Native cross-module linkage enables seamless function expansion.
2. Fully Configurable System for Business Autonomy Most QMS products feature rigid, pre-set workflows that force businesses to adapt to the system. Akso allows full configuration of forms, workflows, reports and access permissions, putting full control of business processes in the client’s hands. With leadership involved throughout the design process, the system fits on-site operations perfectly and achieves smooth adoption.
3. Visual Workflow Diagrams for Clear Alignment Written requirement documents often lead to divergent interpretations. We deliver visualized workflow diagrams immediately after process mapping, enabling instant feedback and revisions, which drastically reduces rework and builds early client confidence.
4. Prioritize Workflow Streamlining Before System Configuration Many vendors rush to deploy systems based on superficial requirements, simply migrating offline chaos into digital tools. We always dedicate time to on-site interviews and gap analysis to align ideal workflows with actual operations before any configuration work starts. Though this takes extra time upfront, both sides recognized its long-term value in post-project reviews.
5. Rigorous Validation and In-Depth Testing The vaccine industry faces stringent regulatory oversight with zero tolerance for compliance risks. While many players cut corners on validation to accelerate launch, we adhere to complete IQ/OQ/PQ protocols. All test cases covering regular workflows, exceptions and edge cases are verified jointly by both teams. Our thorough approach gives the client full confidence when facing regulatory inspections — the very foundation of our long-term partnership.
6. Value-Driven Expansion Instead of Hard Selling The scope of Phase 2 and Phase 3 was never proposed by our sales team. Instead, we conducted regular system operation reviews to identify optimization opportunities, and the client voluntarily decided to expand functionalities. Our role as a trusted advisor focused on continuous improvement, rather than a vendor pushing new contracts, is the core of our enduring partnership.

Closing Thoughts

During the Phase 1 recap meeting, the client shared a comment that meant the most to our team: “We had multiple QMS vendors to choose from a year ago. Looking back, partnering with you was absolutely the right decision.”

The vaccine industry operates under strict compliance rules with minimal margin for error. A successful QMS implementation relies not only on technical expertise, but also on earning trust from the very first phase and consistently delivering on commitments for every subsequent project.