What is QMS Setup?
Our service delivers end-to-end QMS design, including ICH Q10 implementation, SOP and BMR/BPR drafting, electronic document control systems, and training management programs, ensuring GMP-compliant operations.
QMS Setup for Pharmaceutical Compliance
Build Robust Quality Systems with Expert ICH Q10 Guidance
At Indivirtus Healthcare Services Pvt. Ltd., our QMS Setup service empowers pharmaceutical manufacturers to establish or modernize a regulatory-aligned Quality Management System. From ICH Q10 implementation to SOPs, document control, and scalable training programs, we ensure audit-ready compliance and operational excellence.
Why is it Critical?
A robust QMS ensures product quality, regulatory compliance, and operational efficiency, minimizing risks and preparing facilities for global audits and market approvals.
Our Role in Your Success
As a trusted CRO, Indivirtus Healthcare Services provides expert-led QMS solutions, guiding manufacturers to build scalable, compliant quality systems tailored for new or existing facilities.
Our Expert QMS Setup Approach
At Indivirtus Healthcare Services, our QMS Setup service is led by certified regulatory experts specializing in ICH Q10 compliance. We design tailored quality systems, drafting and reviewing SOPs, BMRs, and BPRs, deploying electronic document control systems, and establishing scalable training programs to ensure seamless implementation.
Our approach includes comprehensive assessments of your facility’s needs, delivering audit-proof solutions that align with global GMP standards. We focus on practical integration and continuous improvement, ensuring your QMS supports regulatory readiness and operational efficiency.
QMS Setup Deliverables
ICH Q10-based QMS Design Blueprint: Comprehensive roadmap for quality system implementation.
SOPs, BMRs, and BPR Templates: Standardized documents tailored to your operations.
Document Control System Architecture: Framework for electronic documentation management.
Training Matrix & Record Management Tools: Scalable tools for training program management.
Audit Readiness & CAPA Support: Resources for regulatory audits and corrective action planning.
Regulatory Compliance & Global Standards
Our QMS Setup services align with stringent global standards, ensuring your quality systems are audit-ready and compliant with international markets. By adhering to industry-leading guidelines, we deliver solutions that enhance quality assurance and regulatory confidence.
- ICH Q10: Pharmaceutical Quality System framework for robust QMS design.
- WHO TRS 1019: Global GMP guidelines for quality assurance.
- US FDA 21 CFR Part 211: U.S. regulations for pharmaceutical manufacturing and quality control.
- EU GMP: European guidelines for good manufacturing practices.
- ISO 9001: International standard for quality management systems.
Applications & Use Cases
Our QMS Setup services are essential for pharmaceutical manufacturers establishing new facilities or modernizing existing ones to ensure GMP compliance. Ideal for QA, QC, and compliance teams, our solutions support regulatory audits, facility expansions, and new product launches. Key use cases include implementing ICH Q10-compliant systems, streamlining document control, and building scalable training programs for global market readiness.
Why Choose Indivirtus Healthcare
Indivirtus Healthcare Services is a trusted partner for pharmaceutical manufacturers, delivering expert-led QMS setup solutions backed by certified regulatory experts with global experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we empower your facility with robust, compliant, and scalable quality systems, driving regulatory success and operational excellence.
Frequently Asked Questions
Frequently Asked Questions
What does ICH Q10 QMS development include?
It includes setting up a structured quality management framework aligned with ICH Q10, covering documentation, roles, management responsibilities, and product lifecycle approaches.
How do SOPs and BMR/BPR contribute to GMP compliance?
SOPs standardize operations while BMRs and BPRs ensure traceable, batch-level documentation — both are essential for maintaining GMP compliance and audit readiness.
What are the benefits of implementing an EDMS?
An EDMS improves document control by enabling electronic versioning, controlled access, approvals, metadata tagging, and audit trails, all while supporting data integrity.
What does a training management system typically include?
It includes training matrices by role, training content plans, effectiveness evaluations, and digital tracking of training records for GMP-relevant personnel.
Can the QMS setup service be customized for different facility types?
Yes, we customize QMS setup based on the facility type — whether it’s for oral dosage forms, injectables, APIs, or biotech — and align documentation accordingly.
What does the QMS Setup service include?
Our service includes ICH Q10-based QMS design, drafting and reviewing SOPs, BMRs, and BPRs, deploying electronic document control systems, and establishing scalable training management programs.
Who benefits from QMS Setup services?
Pharmaceutical manufacturers establishing new facilities or modernizing existing ones, particularly QA, QC, and compliance teams, benefit from our tailored QMS solutions.
How does the service ensure regulatory compliance?
Our QMS services align with ICH Q10, WHO TRS 1019, US FDA 21 CFR Part 211, EU GMP, and ISO 9001, ensuring your quality systems are audit-ready and compliant with global standards.
What deliverables are provided with the QMS Setup service?
Clients receive an ICH Q10-based QMS design blueprint, SOPs, BMRs, and BPR templates, document control system architecture, training matrix and record management tools, and audit readiness/CAPA support.
Can the QMS Setup be customized for our facility’s needs?
Yes, our QMS solutions are tailored to your facility’s specific operational and regulatory needs, ensuring practical and compliant systems for your unique processes.
How does the service support training management?
We provide a scalable training matrix and record management tools, enabling your team to implement and track training programs aligned with GMP and regulatory requirements.