Reporting & Release

The tasks for Phase 8: Reporting and Release, according to the validation stages for computerized systems (CS) based on GMP/GAMP, include:

Ensuring that all previous validation stages outlined in the Validation Master Plan (VMP) are completed.
Confirming that all completed validation stages have received positive conclusions.
Verifying the existence, completeness, and proper documentation of validation records (protocols/reports).
Adapting the Quality Management System (QMS) of the company for the validated CS.

During this phase, a review of all validation activities is conducted, summary reports and the traceability matrix (TRM) are filled out. Additionally, the new CS is integrated into the company's Quality Management System (QMS), which includes developing procedures, work instructions, forms, training programs, and schedules, among other things.

At the reporting and release stage, no further validation testing of the CS is conducted – it is solely a phase for finalizing results. The procedure and documentation formats vary significantly depending on the specific quality system requirements of the company.

Several essential requirements must be met for CS reporting and release within the validation framework:

Complete coverage of all stages as per the validation matrix in the Validation Master Plan (VMP).
Traceability from Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and User Requirements Specifications (URS) to design specifications, tests across all validation stages, and their results/documentation.
The presence of an overall conclusion on the successful validation of the CS.
Documentation in compliance with GMP requirements (Good Documentation Practices) and Change Control.
Adaptation of the quality system to include the validated CS.

Other aspects of reporting and releasing the system are determined by the company itself.

Summary Reports for CS Validation Stages

As computerized systems typically consist of numerous elements/subsystems and require a wide range of tests, each validation stage generates many individual protocols/reports. Summary reports compile the results of tests from individual protocols/reports of a validation stage into a single document. Summary reports also include references to individual protocols/reports, ensuring traceability.

The format of the summary report can vary, but it must include all essential elements according to GMP documentation requirements. Typically, individual protocols/reports are appended to the summary report. Summary reports may also be prepared immediately after completing each validation stage.

Traceability Matrix

A traceability matrix is a table that establishes connections between individual requirements, product/process parameters, validation stages, and relevant documents.

A typical chain of connected elements in the traceability matrix may look like this:

Critical Quality Attribute (CQA) of the product (e.g., sterility)
Critical Process Parameter (CPP) (e.g., sterilization temperature)
Risk analysis (e.g., risks associated with sterilization temperature)
URS and development specifications of different levels
Design Review (DR/DQ)
Installation Qualification (IQ)
Low-Level Testing (OQ)
High-Level Testing (PQ)

The traceability matrix can be developed during the design phase and completed as validation stages progress. It is also crucial to update entries in the Traceability Matrix whenever a parameter is changed (e.g., a new version of a document is released).

Final Report

The final (summary) CS validation report serves to document the overall conclusion on the successful validation of the CS.

While the format of the final validation report is not strictly regulated, it must meet – as all other regulated documents – GMP documentation requirements. The final CS validation report must reference all validation documentation on which the conclusion of successful validation is based, specifically:

Individual summary reports for the CS validation stages
Individual validation test protocols/reports

QMS Procedures

Once the CS implementation project has been completed at the company, including computerized system validation, the Quality Management System (QMS) must be appropriately adapted:

The new CS must be included in the relevant registers and logs.
Responsible personnel for system operation, support, and maintenance must be designated.
Procedures (SOPs, instructions) for working with the new CS must be developed and implemented.
Relevant training must be conducted.

According to GAMP5 guidance, changes may be required in the following procedures/processes:

Policies (QMS Manual)
Role and responsibility allocation (SOP)
Training (SOP)
Supplier management (SOP)
System registry development/maintenance (SOP)
General validation planning (SOP)
Monitoring/improvement planning (SOP)

Procedures related to CS operation should cover the following processes:

Commissioning (Go-live)
Implementation of system maintenance and monitoring
Corrective and preventive actions (CAPA)
CS Change Control
CS Audits
Backup/restore procedures
System security
Records management
Decommissioning (Retirement)

The specialists at Tarqvara Pharma Technologies have years of experience in conducting qualification, validation, and acceptance tests within the pharmaceutical industry, in full compliance with international, European, and national GMP/GxP regulations and standards.