In the chemical and pharmaceutical industry, the SCADA systems (Supervisory Control And Data Acquisition) play a critical role in the monitoring, control and Data collection of productive processes. Its validation is not just a normative requirement: it is a key tool to guarantee integrity of the data, the security Operational and the compliance with good manufacturing practices (GMP).
Why validate a SCADA system?
SCADA systems control variables such as temperature, pressure, caudal O state of alarms, and allow automated or remote decision making. His validation ensures that:
- They meet functional and user requirements.
- They generate traceable, complete and insurance data.
- They operate reliably under normal and exceptional conditions.
- They respond correctly to failures, events or changes.
- They comply with regulations such as GMP, FDA 21 CFR Part 11 and Gamp 5.
Validation approach
The validation of a SCADA system must be addressed by a structured methodology, based on the system life cycle and in the Defined quality principles in standards such as GAMP 5. This approach guarantees that the system is suitable for provided, that the data generated are complete and that the system meets the applicable normative demands.
The following are described below Main phases of the validation cycle:
- URS – User Requirements Specification
It is the starting point of the validation process, since it defines what the system must do from the point of view of the user and the process. Before writing an effective USer, it is essential to consider a series of questions that will help to define precisely what the SCADA system should do from the operational, functional and regulatory point of view. Some of the key issues that must guide this initial phase are:
- What variables should be monitored?
- What alarms should be configured?
- What reports are needed?
- What access levels should exist?
A well -defined US is essential to ensure that the SCADA meets its functional and regulatory objectives.
- DQ – Design Qualification
It consists of verifying that system design meets the requirements specified in the US, normative regulatory and Good practices of Engineering (GEP). Before confirming that the design meets the user's requirements, it is necessary to review key aspects that ensure compliance with the regulatory standards and the technical viability of the SCADA system. To do this, the following should be taken into account:
- Review system architecture (servers, stations, PLCs, networks)
- Evaluate technical specifications of hardware and software
- Confirm that the design allows to meet data integrity, redundancy, traceability, etc.
- IQ – Installation Qualification
The installed elements are physically validated, verifying that the SCADA is implemented according to the design specifications. To do this, the following elements must be evaluated, which verify the loyalty of the implementation Regarding the approved design:
- Installed hardware verification (models, versions, licenses)
- Software installation (version, initial configuration)
- CONNECTIVITY CONNECTIVITY, PLCS AND SERVERS
- Review of technical documentation, manuals and certificates of components.
- OQ – Operational Qualification
Functional tests are carried out to ensure that The system operates as planned, within defined parameters. This stage requires executing a series of critical evidence, among which are:
- Alarm tests, operation sequences, events and historical
- Simulation of normal and abnormal conditions
- Verification of the operation of the critical elements: Audit Trail, electronic signature, user management
- Recovery tests against electrical or network failure.
- PQ – Performance Qualification
Under real operating conditions, the system must behave stable, safely and repeatablely. The PQ validates that users, processes and productive environment interact effectively with the SCADA. Typical verifications include:
- Tests with real lots (in simulation or controlled production)
- Confirmation of data reproducibility and stability
- Evaluation of the interaction between operators, scada and other systems (month, BMS, ERP, etc.).
Critical aspects to validate
The validation of a SCADA system in chemical and pharmaceutical plants must guarantee not only its technical operation, but also the integrity of the data, traceability and regulatory compliance. We go on to detail the key aspects that must be carefully evaluated:
User management and accesses
The system must have defined User profiles according to functions (operator, supervisor, administrator, etc.) and properly limit privileges. It is essential to validate that the authentication is safe and that all activities are registered in the Audit Trail, guaranteeing traceability and responsibility on each action carried out in the system.
Data integrity and traceability
It is crucial that the process data, events, alarms and modifications are automatically, safely and unauthorizedly registered. The Audit Trail must be inviolable, record the identity of the user, the action made, the date and time, and, when appropriate, the reason for the change. This point is determinant to comply with regulations such as FDA 21 CFR Part 11 and GMP.
Alarms and interlocks
Alarms must be configured with clear activation and priority criteria, and their notifications must be verifiable. It is also important to validate security interlocks, which protect the system from failure conditions (for example, interruption of a pump if there is no detected flow). This contributes to the Deviation prevention and Improve operational security.
Communications and integration with other systems
It is due Check bidirectional communication between scada, PLCs, sensors and other systems (BMS, month, lims). This includes the validation of response times, data transmission without errors, and the ability to detect and react to connection losses. Interoperability must be clearly documented and proven.
Backup and recovery
The existence and efficacy of automatic backup and manuals should be verified, as well as the restoration procedures against incidents. A validated scada system must ensure that your Information can be recovered in full and reliable After a failure, unexpected stop or energy loss.
Settings and change control
It is essential to confirm that any change in the system (configurations, scripts, parameters) follows a formal change management procedure, with Impact assessment, traceability and revalidation When necessary. This maintains the integrity of the system and ensures its conformity over time.
Operating reports and records
Reports must be complete, legible, exact and generated automatically. It is important to validate that these records faithfully reflect the Historical data of the process and that can be exported, signed or filed according to normative requirements.
The validation of SCADA in the pharmaceutical or chemical industry is not just a legal requirement: it is an intelligent preventive measure. It ensures the accuracy of the data, guarantees operational continuity and simplifies regulatory compliance, thus reducing the risks of unplanned stops or critical findings in audits.
In IDI, we offer specialized solutions in the validation of SCADA systems under GMP and FDA regulations, accompanying our customers throughout the system's life cycle, from design to their operation in productive environment.