IT Quality Management
First organize, then validate. Establish solid foundations before validating.
Why organize before validating?
The first question asked during audits is: Do you have a systems inventory according to regulations? A non-existent or disorganized inventory is a bad start to an inspection.
At DRP we understand that validation is only part of the process. To achieve reliable, auditable and sustainable structures, you must first establish the right conditions.
Key Benefits
Inventory according to regulations
We create a complete inventory of all your IT systems, classified by criticality and regulatory requirements.
Organization ready for inspections
We establish a documentary and procedural structure that withstands any internal or external audit.
Proactive risk management
We identify and control risks before they become problems during inspections or validations.
Optimized processes
We eliminate redundancies and establish efficient workflows that save time and resources.
End-to-end tracking
We implement traceability systems that allow tracking each process from its origin to its final result.
Foundation for validation
We create the technical and documentary foundation necessary for future validations to be successful and efficient.
Our Process
Current state assessment
We survey all existing IT systems, their criticality, current documentation and level of regulatory compliance.
Risk categorization
We classify each system according to its impact on product quality, critical data and specific regulatory requirements.
Master inventory creation
We develop a complete inventory with all technical, functional and regulatory information for each system.
Controls implementation
We define and implement the necessary controls to maintain the integrity and compliance of each system.
Formalization and transfer
We deliver all organized documentation and train your team to maintain the quality management system.
Service Features
Technical Aspects
- Inventory according to PIC/s EMA 11
- GxP criticality classification
- Critical data flow mapping
- Risk assessment per system
- Complete technical documentation
- Maintenance procedures
Regulatory Aspects
- 21 CFR Part 11 compliance
- GAMP 5 alignment
- Regulatory audit preparation
- Complete documentary traceability
- Defined access requirements
- Contingency options per system
Why choose DRP for Quality Management?
We know the industry from within
Over 40 years of combined experience in the pharmaceutical industry. We're not external consultants, we are Pharma.
Real solutions, not theoretical
We design systems that actually work day-to-day, considering operational limitations and realities.
Ready for any inspection
Our systems have withstood inspections from FDA, ANVISA and other international regulatory agencies.
Ready to organize before validating?
Don't wait for an inspection to find you disorganized. Establish the solid foundations your operation needs.
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