Skip to Content

ERP System Validation & Qualification

ERP Validation

TechTides Global specializes in regulatory compliance, especially for industries like pharmaceuticals and medical devices. Their global expertise ensures ERP implementations meet domestic and international standards, covering aspects such as data integrity, system security, and audit readiness​.

Benefits of Validation with TechTides Global

TechTides Global provides validation solution, ensuring compliance with industry regulations such as FDA, EMA, and MHRA. These solutions include templates and tools like validation plans, traceability matrices, negative tests and test scripts (IQ, OQ, PQ) that streamline the validation process. This approach minimizes manual effort, accelerates compliance, and reduces the risk of regulatory scrutiny.

Validation & Qualification Brief

Validation is the documented process of ensuring that a system meets its intended use and performs its functions in compliance with regulatory standards. It focuses on verifying that the processes within the system consistently yield accurate and reliable results.

Qualification is the process of verifying that system components (hardware, software, and environment) function correctly and reliably to support the validated processes. It ensures that the technical and operational aspects of the system meet predefined standards.


ERP Compliance and Regulatory Validations

Ensures ERP systems meet global regulatory standards like 21 CFR Part 11.

Covers installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).

Both Validation and Qualification are integral to ensuring that computerized systems comply with regulatory standards. Together, they guarantee:

  • Data Integrity: Protecting electronic records and ensuring their authenticity.
  • Regulatory Readiness: Providing documented evidence for audits.
  • Operational Excellence: Enabling seamless, compliant operations.

By separating process validation (what the system does) from system qualification (how the system works), organizations can achieve a robust, compliant, and reliable computerized environment.

Regulatory Compliance - System Controls

Controls act as the backbone of the qualification process, ensuring that systems are secure, reliable, and capable of supporting validated processes. By focusing on access, security, consistency, and compliance, controls enhance the system's robustness, laying a foundation for operational excellence and regulatory readiness.

Regulatory frameworks like 21 CFR Part 11 emphasize the implementation of controls for electronic records and signatures:

  • Electronic Signature Controls:
    • Validate that electronic signatures are unique, verifiable, and non-repudiable.
  • Time-Stamp Controls:
    • Ensure accurate time-stamping of data entries and transactions.


System Integrity Checks & Security

Verifies system controls such as user authentication, access levels, and audit trails to enhance data integrity and prevent unauthorized modifications.

Confirms alignment with ALCOA & ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).

Authentication Mechanisms

  • Enforce strong password policies and multi-factor authentication (MFA).
  • Example: Verifying user identity before granting system access.

Encryption Controls:

  • Protect data at rest and in transit to ensure confidentiality.

Backup and Recovery Controls:

  • Enable data recovery in case of system failure or disaster.

CSV Stages

  • Installation Qualification (IQ): Confirms that the system is installed according to specifications (e.g., server configurations, database installations).
  • Operational Qualification (OQ): Ensures that the system performs as expected under typical conditions (e.g., automated workflows, alerts).
  • Performance Qualification (PQ): Verifies that the system operates effectively in real-world conditions (e.g., system performance during peak loads).

Data Entry Controls for Purity and Accuracy 

Controls to avoid pitfalls of inputting incorrect or incomplete data, which can compromise system reliability and decision-making.

Data Input Validation:

  • Ensures only valid and acceptable data is entered into the system.
  • Example: Rejecting incorrect formats or missing fields.

Automated Alerts:

  • Notify users of critical events like unauthorized access or data breaches.

Periodic Health Checks:

  • Regularly evaluate system performance, backups, and data integrity to preempt issues.

Validated Environment - Operational Consistency 

Controls standardize system behavior across various conditions:

  • System Configuration Controls:
    • Validate that system settings are configured according to approved protocols.
    • Example: Ensuring consistent database settings during installation.
  • Environment Monitoring:
    • Confirm system stability under varying environmental conditions like power fluctuations, network latency, or server loads.
  • Change Management Controls:
    • Monitor and document any changes to the system to ensure they do not compromise validation.


Enhancing Data Integrity 

Controls ensure that data within the system adheres to ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate):

  • Access Controls:
    • Restrict access to authorized personnel to prevent unauthorized modifications.
    • Example: Role-based access controls (RBAC).
  • Audit Trails:
    • Automatically record all system activities, including data creation, modification, and deletion.
    • Provide transparency and traceability for regulatory audits.

CSV - Importance Of System Controls

In the qualification phase of Computer System Validation (CSV), controls play a vital role in ensuring the system operates reliably and securely while maintaining compliance with regulatory requirements. These controls are mechanisms, checks, and balances built into the system to safeguard data integrity, operational consistency, and regulatory adherence.

 GAP Analysis

GAP analysis evaluates an organization's existing processes and systems against the regulatory requirements of 21 CFR Part 11. GAP analysis reinforces the quality of electronic records and signatures, promoting the reliability, security, and authenticity of data.