Documentation

Documentation

About the service

Organize, standardize and strengthen your processes with quality documentation.

At Q&I_4U, we know that well-structured documentation is the basis of an efficient quality system. Our Documentation service helps companies develop, review and maintain clear and organized records, ensuring compliance with regulatory standards and optimizing processes.

Documentation

What we offer

Document Preparation and Review

We create or enhance your quality system documentation, ensuring clarity, standardization, and compliance with industry best practices.

Validation Master Plan

We structure a master validation plan to ensure that your company’s critical processes are documented and validated according to regulatory requirements.

Quality Manual

We develop customized quality manuals to reflect your company’s standards, strengthening governance and process control.

Site Master File or Plant Master File

We create detailed master files that describe your facilities, equipment, and production processes, providing a comprehensive view of your quality system.

Standard Operating Procedures (SOPs)

We develop Standard Operating Procedures (SOPs) to ensure consistency and efficiency in executing your business activities.

Work Instructions

We create clear and objective instructions to guide your team in correctly performing critical tasks, reducing errors and improving productivity.

Quality Risk Management

We implement effective risk management methodologies to prevent failures and ensure the integrity of your production processes.

Drug Master File (DMF) or Active Master File (AMF)

We prepare the necessary technical documentation for the registration and certification of active pharmaceutical ingredients and regulated products.

CAPA (Corrective and Preventive Actions)

We assist in implementing an efficient CAPA system to identify, correct, and prevent non-conformities.

Q&I_4U?

Why choose Q&I_4U?

Security

Greater security and control over your processes.

Reduce risks

Reduced risks and increased operational efficiency.

Dream Team

A specialized team in quality and regulatory compliance.

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