For more than 35 years, SeerPharma has been a trusted partner to pharmaceutical and medical device organisations across the Asia-Pacific (APAC) region, providing expert guidance on Quality Management Systems (QMS) and Good Manufacturing Practice (GMP) compliance.
At the heart of our work lies a team of highly experienced quality and regulatory professionals who have spent decades designing, reviewing, and refining QMS frameworks. Our mission is to help clients clearly define their operational processes while meeting the stringent requirements of GMP and other regulations or standards relevant to their market and product lifecycle.
Over the past decade, there has been a surge in investment from both government and private sectors to translate research outcomes from public institutions into commercially viable pharmaceutical and medical technology products. This evolving landscape has led to a significant increase in demand for SeerPharma’s expertise—particularly among early-stage and scale-up organisations seeking to build foundational quality systems that can mature alongside their product development and commercialisation journey.
Recognising this need, SeerPharma has worked closely with clients across the region to implement staged QMS frameworks. These systems provide a strong foundation for growth, regulatory readiness, and operational excellence while allowing flexibility as the organisation and its products progress through development milestones.
Increasingly, our clients also recognise that a QMS is not merely a collection of documents—it is a dynamic system that evolves with the organisation. As companies grow, maintaining efficiency and traceability becomes more complex, making digital transformation of quality processes an essential step.
Through our strategic partnership with MasterControl, SeerPharma supports clients in designing and implementing digital-ready QMS frameworks. This approach ensures that the transition from paper-based or hybrid systems to a fully digital environment is seamless and effective, setting the stage for long-term success. Our team has extensive experience developing and deploying QMS documentation with digitisation and automation in mind.
Staged QMS implementation can be suitable for multiple reasons in early-stage companies including budget management or alignment with product lifecycle development (from R&D through to commercialisation). The following table defines a staged approach to QMS roll-out that was implemented with a client to achieve the benefits of QMS while working within their budget constraints.
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Stage
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Document Name
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Stage 1
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Quality Policy Template
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CAPA (Corrective & Preventive Action) Procedure
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CAPA Register
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CAPA Form
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Deviation Management
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Deviation Register
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Deviation Form
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Training and Personnel Management
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Training Register
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Training Record
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Training Attendance Form
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Personnel Hygiene and Medical Checks
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Supplier Qualification and Management
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Supplier Evaluation Questionnaire
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Approved Supplier Register
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Quality Agreement Template
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Documents and Records Management
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Document Register
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Document Change Request
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Document Periodic Review
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Change Control Procedure
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Change Control Form
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Change Control Register
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| Stage 2 |
Facility Management
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Visitor Logbook
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Pest Control
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Equipment Management
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Equipment Logbook
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Calibration and Maintenance Register
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Computer System Management
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Computer System GxP Assessment
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Computer System Register
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Computer System Periodic Review
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Data Integrity
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| Stage 3 |
Quality Manual
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Site Master File
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Quality Management Review
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Quality Management Review Register
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Quality Management Report
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Product Quality Review
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Product Quality Review Register
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Product Quality Review Report
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Internal Audits
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Internal Audit Schedule
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Internal Audit Report
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Managing Regulatory and Customer Audits
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Quality Risk Management
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Quality Risk Management Register
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Quality Risk Management Form
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Materials Management
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Non-Conforming and Rejected Materials
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Rejected Materials Register
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Materials Disposal Form
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Facility Cleaning
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Facility Cleaning Record
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Gowning
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Material Decontamination
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Environmental Monitoring
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Validation Master Plan
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Stage 4
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Contamination Control Strategy
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Complaints Procedure
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Complaints Register
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Complaints Form
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Recall Procedure
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Recall Register
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Recall Form
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Out of Specification (OOS) Procedure
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OOS Register
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OOS Form
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Reference and Retention Samples Management
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SeerPharma’s methodology draws upon more than three decades of experience and insights gained from working with thousands of organisations worldwide. Our deep understanding of GMP best practices allows us to design fit-for-purpose, scalable QMS frameworks tailored to each client’s growth stage and regulatory environment.
By leveraging this expertise, we help organisations:
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Contact us If you would like support in establishing, reviewing, or enhancing your existing Quality Management Systems