Qualer Validation Traceability Matrix
The United States Code of Federal Regulations does not specifically require a Traceability Matrix (TX), but creating a traceability matrix is recognized as a validation best practice. It serves as a map for auditors to review the test case coverage from individual user, functional, and design requirements to the corresponding test cases that verify the system’s fitness for intended use.
Qualer maintains 21 CFR Part 11 Validation according to the written standard established by the International Society of Pharmaceutical Engineers (ISPE) GAMP 5. Our validation service is executed in accordance with GxP standards producing a validation library that features signed electronic documents.
Multi Tenant Cloud Architecture
Qualer Validation and Compliance Plan – 21 CFR Part 11 Validation
Qualer maintains validation according to the written standard established by the International Society of Pharmaceutical Engineers (ISPE) GAMP 5. Qualer CFR 21 Part 11 Validation Services and multi-tenant cloud architecture reduce the overall time and effort companies spend validating applications. Creating a traceability matrix is recognized as a validation best practice, it serves as a map for auditors to review the test case coverage from individual user, functional, and design requirements.
Qualer’s asset management solution provides companies with easily traceable validation documents, keeping labs compliant while reducing time.
Qualer Provides Asset Management Software for Laboratories and ISO Certified Labs. Our validation service is executed in accordance with 21 CFR part 11 validation standards. With Qualer’s multi cloud architecture, a company reduces the overall time and effort they previously spent validating. Instead, Qualer’s cloud infrastructure enables calibration and documentation to be processed in real-time!
Qualer CFR 21 Part 11 Validation Service
Qualer has created a CFR 21 Part 11 validation service, to validate the system in accordance with GMP standards. Get More Details
Validation & Compliance Plan
The Validation and Compliance Plan (VCP) defines the methodology, deliverables, and responsibilities for the validation of Qualer.
System Design Specifications
The Software Design Specification (SDS) describes the system elements, functions, and configuration necessary to properly operate the system
Functional Requirement Specification
The Functional Requirement Specification (FRS) details the capabilities and functions that the software must be capable of performing.
Operations Qualifications
The Installation and Operation Qualification (IOQ) protocol describes the testing methodology that provides documented evidence.
Validation Summary Report
The Validation Summary Report (VSR) summarizes the results obtained during the execution of the Installation Qualification Protocol.
Validation Deviation Report
The Deviation Summary Report (DSR) documents any test steps from the IOQ that don't match the expected results, or no deviations occurred.
Validation Traceability Report
Federal Regulations does not specifically require a Traceability Matrix (TX), but creating a traceability matrix is recognized as a validation best practice.
