Installation & Operational Qualification
Qualer CFR 21 Part 11 Validation Service Document
Qualer Installation & Operational Qualification
The Installation and Operation Qualification (IOQ) protocol describes the testing methodology and test cases that provide the necessary documented evidence to assure that the Qualer has properly performed in accordance with defined system and regulatory requirements and Qualer procedures. These are the instructions our validation engineer follows to verify the installation and operation of Qualer end-to-end.
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.
GxP Regulatory Requirements
Qualer Validation and Compliance Plan – 21 CFR Part 11 Validation
Qualer was designed to meet the regulatory needs of GxP regulatory requirements of the Life Sciences and other regulated industries. Traditionally, the high costs of validation have caused companies to delay upgrades of business applications—often running three to four years out of date above the normally slow development cycles of legacy software applications. Qualer’s validation services and multi-tenant cloud architecture reduce the overall time and effort companies spend validating applications.
Qualer’s software solution provides compliant digital electronic signatures, while having complete visibility and control across all systems.
Qualer Provides a 21 CFR Part 11 compliant software. In order to be compliant, Qualer provides digital electronic records. Qualer’s compliance software provides all digital documents including the printed name of the signer, the date/time the signature was applied, and the ‘meaning’ or intention of the electronic signature. Qualer’s Validation software gives your company complete visibility and control over the use of these signatures across their systems.
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.
