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Pharma & Lifesciences GAMP solutions



Pharma

The pharmaceutical industry faces significant challenges without an ERP system, including regulatory non-compliance, data integrity risks, inefficient inventory management, and poor batch traceability. Disconnected operations lead to communication gaps, slow product development, and inconsistent supply chain management, ultimately increasing operational costs and compliance risks. Additionally, the lack of real-time insights hinders informed decision making, causing delays and inefficiencies. KeacGMP solution from Ficus Realtime, effectively resolves these issues by streamlining operations, ensuring regulatory compliance, enhancing traceability, and optimizing resource management—enabling pharmaceutical companies to achieve efficiency, quality, and audit readiness.

Life sciences

In the Life Sciences industry, we specialize in developing and maintaining Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) to ensure patient safety and regulatory compliance. Our expertise extends to providing periodic safety updates for proactive risk mitigation. Additionally, our regulatory reporting services include the preparation and submission of PSURs, PBRERs, and both expedited and periodic reports to global health authorities such as the FDA, EMA, MHRA, and PMDA. To streamline compliance, enhance traceability, and optimize regulatory reporting, our KeacGMP solution ensures seamless data management, risk assessment, and audit readiness—empowering life sciences companies with efficiency and compliance.  

Engineering

Is designed to render a powerful advantage for the operation and planning of business units. Engineering supports planning resources for engineered parts, services. Kea cGMP enables the client to exercise the best methods in maintaining the internal engineering related services and facilitates to adopt a suitable maintenance services for their Plant

Regulatory Compliance Consulting

Regulatory Consulting

We provide regulatory publishing and archiving services, including formatting and hyperlinking submission-ready documents. Our fully compliant archiving ensures proper lifecycle management, while we create global and regional dossiers tailored to country-specific guidelines.

CSV

Our regulatory services for Computer System Validation (CSV) are designed to help life sciences and pharmaceutical companies achieve compliance with global regulatory requirements. With a focus on risk management, system integrity, and operational efficiency, our services provide a streamlined approach to validating and maintaining computerized systems critical to your business operations.

Assessment

Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle. Ensuring data integrity is crucial for organizations, especially those in regulated industries such as healthcare, finance, and pharmaceuticals. Here are some common data integrity solutions and best practices that organizations can implement.

How Kea cGMP Helps To Be A Leader

Data Integrity

Empowers the organization to be 100% assured of the operations by enforcing the data integrity rules & principles​ (Ex: Manipulation of Stock data).

Workforce Monitoring​ & Collaboration

Realtime & round-the-clock visibility of employees' activities and productivity across the business functions.

Operation Excellence

With minimal learning curve, the entire organization becomes process-driven, ensuring consistency and predictability in every aspect of business operations.

Improved Employee Productivity

AI-powered document generation ensures no manual efforts on mundane tasks, mitigating the risk of human error. (Ex: Creation of Technical Quotation)

Highly Secure & Trustworthy

Role-based and content-based security & access controls are enforced by design, protecting business-critical information with zero human effort.

Assured Stability & Protection

Removing dependency on a single or group of individuals, the organization is transformed into an interconnected process-driven enterprise.

 

 

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