Would Your Software Support a ANVISA inspection Today?
The pharmaceutical industry is undergoing a digital transformation and regulation follows suit.
Computerized systems without adequate validation represent relevant regulatory risks in modern inspections, focused on data integrity and end-to-end traceability.
Systems requiring regulatory attention
Integrated management of regulated processes
Laboratory Management Systems
Manufacturing execution and control
Electronic quality management
Process automation and control
Chromatographs, scales, equipment
Excel validated according to GAMP 5
Proprietary and internal software
Main risks of an unvalidated system
Each of these points can become a 483 observation, critical deviation or non-compliance in a regulatory inspection.
Traceability Failures
Inability to reconstruct the history of critical data.
Inconsistent Data
Divergent records between systems and paper.
Incomplete Records
Gaps in required audit evidence.
Uncontrolled Changes
Data modifications without versioning or approval.
Inadequate Access
Profiles and permissions without ALCOA+ control.
Lack of Audit Trail
Audit trail missing, disabled or not reviewed.
Loss of Evidence
Non-Conformities in Inspections
483 Observations, deviations and warning letters.
"Um software funcionando não significa um software validado."
The difference lies in documented evidence, requirements traceability and life cycle control.
Computerized System Validation explained in a technical and direct way
CSV is the documented process that proves, with objective evidence, that a computerized system consistently performs its functions within specifications and meets applicable regulatory requirements.
Risk-based and life cycle approach to computerized systems.
Effort proportional to the GMP impact and the complexity of the system.
From conception to discontinuation, with continuous change control.
ANVISA RDC 658, FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S.
Each requirement traces back to a test and an objective result.
IQ/OQ/PQ protocols executed, reviewed and formally approved.
Validation Lifecycle
How we run a CSV project from start to validated state
Structured steps, clear deliverables and full traceability — aligned with GAMP 5 and best regulatory practices.
- 01
Initial Assessment
System diagnosis, regulatory scope and preliminary GAP analysis.
- 02
Requirements Gathering
URS, functional and technical specifications aligned to the process.
- 03
Risk Analysis
FMEA and GAMP 5 classification with risk-based approach.
- 04
Validation Plan
VMP and VP with defined strategy, roles and deliverables.
- 05
IQ/OQ/PQ protocols
Development of qualification protocols traceable to requirements.
- 06
Test Execution
Documented execution, objective evidence and handling of deviations.
- 07
Final Report
Validation summary, system release and traceability matrix.
- 08
Validated State Maintenance
Change control, periodic review and revalidation.
Systems that can be validated
We operate across the entire spectrum of computerized systems with GMP impact — from critical spreadsheets to corporate cloud platforms.
What does your company gain from a well-executed CSV project
Regulatory compliance
ANVISA, FDA 21 CFR Part 11, PIC/S and EU Annex 11.
Data Integrity
ALCOA+ principles applied throughout the data cycle.
Operational Security
Access controls, authentication and segregation of duties.
Traceability
Complete history of requirements, tests and changes.
Risk reduction
Proactive mitigation of regulatory and operational failures.
Preparation for Inspections
Dossiers ready for internal and external audits.
Reliability of Records
Defensible and auditable electronic evidence.
Digital Maturity
Structured evolution of validated IT governance.
Diferenciais T&B Pharma Consulting
We combine deep regulatory knowledge with technology fluency to deliver defensible, efficient and proportionate CSV projects to the real risk of your system.
Find out if your systems are truly ready for an inspection
Frequently Asked Questions
GAMP 5 (Good Automated Manufacturing Practice) is the ISPE guide that establishes a risk-based and lifecycle approach for validating computerized systems in regulated industries, optimizing effort according to the complexity and risk of the system.
Data Integrity is the set of principles (ALCOA+) that ensures that data is Attributable, Readable, Contemporary, Original, Accurate, Complete, Consistent, Durable and Available throughout its entire lifecycle.
IQ (Installation Qualification) verifies correct installation. The Q (Operational) confirms that the system operates according to specifications. PQ (Performance) demonstrates consistent performance in the real-world usage environment with real data.
It depends on the complexity and GAMP category of the system. Projects can range from 4 weeks (spreadsheets and category 3 systems) to 6+ months (custom category 5 systems). The initial risk analysis defines the realistic timeline.
Validation Master Plan (VMP), Validation Plan (VP), URS, FRS, Risk Analysis, IQ/OQ/PQ Protocols, Traceability Matrix, Execution Reports, Validation Summary and validated status maintenance procedures.
The customer is very important, the customer will be followed by the customer. As the land of the land, the mourning nor the corporal of the land, the pillow of the lion.
