Enterprise Software Validation Services

GAMP 5 (Second Edition)

Offers a structured V-model framework for the development, configuration, and validation of computerized systems.
Emphasizes risk-based validation, scalable documentation, and clear delineation of responsibilities across the system lifecycle.
Classifies systems based on complexity (Categories 1, 3, 4, and 5) to tailor the level of validation effort.

FDA’s Computer Software Assurance (CSA) for Production and Quality System Software

Encourages critical thinking and risk-based assurance activities over burdensome, documentation-heavy testing.
Promotes the use of unscripted, exploratory, and ad hoc testing, where appropriate, to focus efforts on features impacting product quality and patient safety.
Intended to modernize software validation practices under 21 CFR Part 11, Part 820, and applicable predicate rules.

1. Validation Planning and Risk Assessment

Authoring of Validation Plans (VP) and Risk Assessments (RA) tailored to system criticality and intended use.
Determination of GAMP categories and CSV/CSA hybrid strategy, aligned with your internal SOPs and regulatory risk appetite.
System impact assessment on product quality, data integrity, and compliance posture.

2. Requirements Definition

Development or refinement of User Requirements Specifications (URS).
Collaboration with stakeholders to define intended use, regulatory impact, and functional expectations.
Support for gathering requirements from QA, Operations, IT, and Compliance teams.

3. Functional & Design Specifications

Drafting of Functional Specifications (FS) and Design Specifications (DS) in line with vendor documentation, system configurations, and workflow customizations.
Support for configuration specifications (CS) where applicable (GAMP 4/5 systems).

4. Risk-Based Testing (GAMP/CSA-Aligned)

Scripted testing for high-risk functions: IQ/OQ/PQ protocols, installation verifications, access controls, audit trails, etc.
CSA-guided unscripted testing for low-risk configurations and core-out-of-box functionality (e.g., label design templates, non-critical calculations).
Execution support for:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Security Testing & Backup/Restore Verification
- Data Integrity Risk Assessments

5. Computer Software Assurance Techniques

Incorporation of vendor testing, exploratory testing, ad hoc testing, and automated testing tools where justified by risk.
Documentation of assurance activities using CSA-justified formats (e.g., test summaries instead of formal test scripts).
Lean execution strategies for indirect impact platforms (e.g., ERP platforms) per CSA guidance.

6. Data Migration & Interface Validation

Risk-based approach to validating data migration from legacy systems using sampling strategies such as ANSI/ASQC Z1.4-2018.
Verification of interfacing and data transfer integrity between interconnected platforms (e.g., CMMS to MES).

7. Audit-Ready Documentation Packages

Generation of full validation lifecycle documentation in accordance with GAMP 5:
- Validation Plan
- Requirements & Specifications
- Risk Assessments
- Protocols & Test Scripts
- Summary Reports
- Traceability Matrices
Support for electronic validation documentation via platforms like Kneat, ValGenesis, or proprietary templates.

I provide validation services for both custom and commercial off-the-shelf (COTS) systems used in GxP environments: