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Software Validation Deliverables Generated by cGen e‑Validation star Platform (compligen)

Overview of Validation Deliverables

The life‑science sector is highly regulated, and computerized systems used to manufacture, store or analyze products must be validated to confirm they consistently perform as intended and maintain data integrity. “Computerized system validation” (CSV) and its modern, risk‑based successor, Computer Software Assurancerance, require defined deliverables and evidence for every stage of the validation life‑cycle. The cGen e‑Validation platform offered by compligen automates the creation of these deliverables using our power-driven AI technology, helping teams follow regulatory guidance such as FDA 21 CFR Part 11, FDA CSA, EU Annex 11 and GAMP 5.

Software Vendor Audit

A software vendor audit evaluates a supplier’s quality management and development practices before purchasing or configuring software. GMP guidance notes that bespoke hardware or software development requires a supplier audit to verify that the vendor’s design and testing processes meet regulatory requirements and that assembled systems are compatible. These activities culminate in a report describing the vendor’s quality system, software development life‑cycle, testing practices, training records and any gaps or corrective actions.
How cGen automates it: cGen collects vendor questionnaires, generates risk‑based audit plans and checklists, tracks document reviews and produces a digital audit report that captures findings, evidence and corrective‑action items. Electronic signatures and version control support audit approvals and ensure an auditable record.

Validation Plan (VP)

The validation plan (VP) establishes the strategy for validating a computerized system. It is a comprehensive roadmap describing the validation scope, objectives, roles and responsibilities, system overview, validation strategy, acceptance criteria and deliverables. Assurea notes that a VP defines the purpose, boundaries of the validation, roles of the system owner and quality assurance, and a risk‑based strategy—including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) phases.
It also lists the deliverables to be created—such as user requirement specifications, functional specifications, risk assessments, test protocols and the requirements traceability matrix—along with references to relevant regulations. GMPSOP guidance adds that each validation effort must have a validation plan specifying which systems require validation, the activities and documentation to be produced and the quality policy; the plan must be approved by the system owner and, where applicable, by quality assurance.

How cGen automates it: In cGen, the validation plan template is automatically populated using our power-driven AI technology with project metadata (system name, version and classification), predefined roles and a configurable risk‑based strategy. Users can select applicable regulations, and the platform generates the required sections with hyperlinks to company SOPs. Electronic signatures and version control ensure that the VP is reviewed and approved before testing begins.

System Requirements Specification (SRS)

The System Requirements Specification (SRS ) defines what the system must do and how it should perform. Visure’s requirements management guide explains that a SRS outlines functional requirements (the tasks or operations the system must perform), non‑functional requirements (performance, security and usability), system constraints (limitations such as budget or technology) and interface requirements describing interactions with users or other systems.

Unlike a software requirements specification, which focuses on software modules, a SRS encompasses the entire system—including hardware, software, processes and interactions—and serves as the blueprint for design, development and implementation. A well‑written SRS reduces misunderstandings and provides a common reference for stakeholders throughout the validation project.

How cGen automates it: cGen enables users to import requirements from external documents or capture them using built‑in forms that utilize our power-driven AI technology. Requirements can be categorized as functional, non‑functional or interface‑related, assigned priorities and risks, and linked to design specifications. The platform supports review workflows, change tracking and qualification activities via the traceability matrix.

Installation Qualification (IQ)

Installation Qualification (IQ) confirms that equipment or software has been installed according to manufacturer specifications and is ready for use. compligen describes IQ as verifying that equipment and ancillary systems have been installed and configured correctly; for software, this includes verifying folder structures and minimum system requirements.
IQ documentation typically consists of an IQ protocol detailing the equipment identification, installation requirements, environmental conditions and acceptance criteria, a checklist covering physical installation, electrical connections, calibration and software installation, and an IQ report summarising results and confirming that the installation meets predefined criteria.
How cGen automates it: cGen generates IQ protocols using standard templates and our AI driven automation that list software details, pre‑installation requirements and acceptance criteria. Users can record installation observations, attach photographs or configuration screenshots and electronically sign the IQ report. The platform maintains version control and supports re‑qualification activities when software or hardware is modified.

Operational Qualification (OQ)

Operational Qualification (OQ) is performed after IQ to confirm that the system operates within its specified limits and meets user requirements. OQ tests determine whether equipment performance is consistent with the user requirements within the manufacturer’s operating ranges and that all items in the test plan are thoroughly documented. OQ documentation includes an OQ protocol specifying objectives, scope, methodology and acceptance criteria, detailed test scripts or checklists describing steps and expected results, and an OQ report summarising test outcomes and any deviations. Critical SOPs, calibration records and a traceability matrix linking requirements to test cases should also be referenced.
How cGen automates it: cGen generates OQ tests automatically from the requirements and system design using our power-driven AI technology. Users select or create test cases, define acceptance criteria and record actual results. The platform enforces bidirectional traceability between requirements and tests, captures electronic approvals and deviations and produces an OQ report that collates results, issues and resolution of non‑conformities.

Validation Summary Report (VSR)

The validation summary report (VSR)consolidates the outcomes of all validation activities and provides evidence that the system meets its intended use. It explains that a VSR summarises the objective of the report, recapitulates the scope of validation, provides an overview of the validation phases and key findings, details any deviations and their resolution, confirms that all requirements have been tested and passed (traceability to requirements) and documents final approval and release.
How cGen automates it: In cGen, the VSR is automatically assembled using our power-driven AI technology from completed IQ, OQ and PQ reports, requirement statuses and risk assessments. The system generates summary statistics (e.g., number of tests executed and passed), lists outstanding deviations and their resolution, and includes electronic approvals from Quality Assurance, IT and system owners. The resulting PDF report can be exported for regulatory submissions or audits.

Requirements Traceability Matrix (RTM)

A requirements traceability matrix (RTM) is a document that maps requirements to related artifacts (design elements, test cases, results and issues) to prove that each requirement has been fulfilled. Perforce Software defines an RTM as a document demonstrating the relationship between requirements and other artifacts and notes that it typically records requirements, tests, test results and issues. Effective traceability should be bidirectional—allowing forward tracing from requirements to test cases and backward tracing from tests or issues to the originating requirement. The matrix helps teams verify that all requirements are tested, manage scope and make informed decisions during the project lifecycle; regulated industries rely on RTMs to prove compliance.
How cGen automates it: cGen automatically constructs the RTM using our power-driven AI technology by linking each requirement captured in the SRS to corresponding design specifications, test cases and qualification results. The matrix is updated in real time as tests are executed and requirements are verified. This dynamic RTM provides full bidirectional traceability and can be exported or viewed within the platform, helping auditors and regulators confirm that every requirement has been adequately tested and approved.

Performance Qualification (PQ)

Performance Qualification (PQ) is the final phase of qualification and demonstrates that the system consistently performs according to user requirements in the intended operating environment. PQ and Process Performance Qualification (PPQ) protocols should include manufacturing conditions (equipment limits and operating parameters), lists of data to record, tests to ensure consistent quality, sampling plans, data‑analysis methods and definitions of variability limits; they must be approved by the quality unit.
How cGen automates it: cGen allows users to use our power-driven AI technology to design process‑level test plans, record real‑time data and integrate with process analytical technology or sensors. The platform generates PQ reports that summarise process performance, sampling results, statistical analyses and conclusions on whether the system is fit for routine use.

Conclusion

Automating CSV deliverables with cGen’s AI technology reduces manual effort and costs, ensures consistency and improves compliance. By generating vendor audit reports, validation plans, detailed specifications, qualification protocols and summary reports directly from templates, the platform helps life‑science companies maintain data integrity and demonstrate regulatory compliance. Electronic signatures, version control and real‑time traceability of requirements to tests enable efficient audits and faster project completion.

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