At Ficus Realtime, we specialize in designing and implementing robust Quality Management Systems (QMS) tailored for pharmaceutical, biotechnology, and life sciences industries. Our QMS framework is built on regulatory standards and best practices to ensure product quality, data integrity, and regulatory readiness at every stage of your business operations.
Our QMS framework is built on regulatory standards and best practices to ensure product quality, data integrity, and regulatory readiness at every stage of your business operations.
Our QMS Services Include
1. Document & Record Management:
Controlled document lifecycle: creation, approval, distribution, and archival
Compliance with 21 CFR Part 11, EU Annex 11, and ALCOA+ principles
Electronic document control systems integration
2. Change Control Management:
Structured approach to assess, document, and approve changes
Impact analysis on quality, safety, and compliance
Audit-trail-based tracking for transparency
3. Training & Qualification:
Competency-based training modules
Role-wise training matrix and tracking
Periodic refresher programs and compliance audits
4. Deviation & CAPA Management:
Real-time deviation tracking Root cause analysis using tools like 5 Whys and Fishbone Preventive action implementation and effectiveness checks
5. Risk Management:
Risk identification, assessment, and mitigation
Aligned with ICH Q9 and ISO 14971 standards
Integration with project and process workflows
6. Internal Audits & Compliance Reviews:
Periodic audits to evaluate QMS effectiveness
Gap analysis reports and remediation plans
Support for regulatory inspections (FDA, WHO, EMA)
7. Supplier Quality Management:
Vendor qualification and audits
Supplier scorecards and performance tracking
Quality agreements and compliance assurance
8. Computer System Validation (CSV):
Validation lifecycle integrated into QMS
Risk-based validation following GAMP 5
IQ/OQ/PQ protocols, traceability matrices, and summary reports
Keeping pace with evolving global standards (FDA, EMA, ISO 9001, ICH Q10, GxP) and ensuring QMS processes meet inspection readiness.
Managing large volumes of SOPs, policies, and records while ensuring version control, accessibility, and audit readiness.
Ensuring ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate) are met across all quality processes and systems.
Handling product, process, or system changes systematically, while identifying and mitigating associated risks.
Difficulty in integrating QMS with ERP, LIMS, MES, and eLogs systems, leading to data silos and inefficiencies.
Ensuring employees are trained, compliant, and actively contributing to a culture of continuous improvement.
Manage documentation lifecycle from creation to obsolescence using AI.
Enable users to search for documents using voice commands.
Detect and highlight differences between document versions automatically.
Get smart suggestions for documentation improvements powered by AI.
See how our Quality Management System simplifies compliance and boosts productivity. Click below to learn more.
Explore Us
Ficusrealtime’s QMS software helps pharma companies stay compliant, ensure data integrity, and simplify quality processes. With seamless integration and an easy-to-use design, it strengthens compliance and boosts efficiency.
Built to meet global standards like FDA 21 CFR Part 11, EU Annex 11, ISO 9001, and GxP guidelines.p>
Connects smoothly with ERP, LIMS, MES, and other pharma systems to create a unified quality ecosystem.
Ensures ALCOA+ principles with complete audit trails, secure access, and accurate documentation.
Flexible architecture that grows with your organization, while providing a simple, intuitive user experience.
End-to-end ERP solutions for pharma and life sciences to manage R&D, manufacturing, compliance, and global regulations seamlessly.
Improve traceability, quality control, and operational agility across the food & beverage supply chain with ERP integration.
Digitize and optimize production processes with ERP that ensures quality, reduces downtime, and enhances overall efficiency.
Boost efficiency in chemical production and petrochemical operations with ERP-driven safety, compliance, and resource optimization.
Advance precision in gene therapy research and production with ERP that ensures compliance, quality, and seamless collaboration.
ERP solutions for medical device manufacturing with strict compliance, product lifecycle management, and operational transparency.
A Document Management System helps organizations by centralizing all critical documents in one secure platform, making them easy to access, share, and track. It reduces the time and cost spent on manual paperwork while ensuring documents are always up to date with version control. With automated workflows, approvals, and audit trails, a DMS enhances compliance with regulatory standards and minimizes errors.
It also improves collaboration across departments, safeguards sensitive information with role-based security, and boosts overall efficiency, enabling organizations to focus more on their core business goals.
KeaGMP runs directly on browsers like Chrome, with no desktop installation required. It is mobile-friendly, enabling users to manage documents anytime, anywhere.
Documents move smoothly through creation, review, approval, and archival with defined workflows. The system guides users step by step to reduce errors and delays.
Access is strictly controlled by user roles and document types, ensuring only authorized personnel can view or edit specific content.
Built-in templates and a document generator help standardize formats and speed up document creation, reducing repetitive work.
Every action is logged to provide full traceability, supporting compliance with GMP, FDA, WHO, and other regulatory standards.
The system ensures tamper-proof documents with strong version control, so users always work on the latest approved version.
Automation reduces time spent on document handling, improves retrieval speed, and lowers costs by avoiding duplication.
KeaGMP supports paperless operations with secure digital storage, cutting down on physical paperwork.
The interface is clean and user-friendly, making it easy for staff to adopt and operate without extensive training.
Testimonials
Deployed a Professional team and Accomplished The Successfull completion of the CSV Project with in our Organization.They Delivered a High Quality out for Chromotography and purified Water System Integrated with PLC-HMI Systems All while ensuring strict adherence to Regulatory standards.
MANGALAM ORGANICS LIMITED
VINS BIOPRODUCTS LIMITED
ORCH LABORATORIES INDIA PVT.LTD
EXTROVIS PRIVATE LIMITED
ISO QUALITY MANAGEMENT SYSTEM
NSJ PRAYOG LIFE SCIENCES PVT.LTD
CERTIFICATE OF EXCELLENCE - KeacGMP & CSV
