Validation Summary Report

Qualer CFR 21 Part 11 Validation Service Document

Qualer Validation Summary Report

The Validation Summary Report (VSR) summarizes the results obtained during the execution of the Installation/Operational Qualification Protocol for the Qualer platform. The Validation Summary Report documents whether the system performed in accordance with its intended use as described in the Functional Requirement Specification and the Software Design Specification.

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.

Validation Protocols

Qualer Validation and Compliance Plan - 21 CFR Part 11 Validation

Qualer’s Validation Service customers receive a validation addendum that includes the full library of validation documents. Qualer works with our validated customers to update their URS and PQ, if needed, to account for new features and enhancements. Qualer’s validation protocol is designed to minimize PQ impact. We take a hands-on approach to streamline updates so our customers can benefit from increased functionality with minimal effort.

Qualer provides a fully validated system that maintains asset equipment control for complete documentation compliance.

Qualer’s Compliance Software allows intricate requirements and automates how vendors service their specific assets through Qualer’s collaborative ecosystem. Within our Validation Compliance Software, Qualer controls access to protect your program’s integrity while eliminating manual processes between you and your vendors. Vendor service documentation is automatically uploaded to Qualer through a portal once work is completed with electronic signatures to keep compliant.

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

1
Validation & Compliance Plan

Validation & Compliance Plan

The Validation and Compliance Plan (VCP) defines the methodology, deliverables, and responsibilities for the validation of Qualer.

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2
System Design Specifications

System Design Specifications

The Software Design Specification (SDS) describes the system elements, functions, and configuration necessary to properly operate the system

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3
Functional Requirement Specification

Functional Requirement Specification

The Functional Requirement Specification (FRS) details the capabilities and functions that the software must be capable of performing.

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4
Operations Qualifications

Operations Qualifications

The Installation and Operation Qualification (IOQ) protocol describes the testing methodology that provides documented evidence.

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5
Validation Deviation Report

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.

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6
Validation Traceability Report

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.

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At Qualer, we’ve created a transformative and collaborative, compliant asset and service management software solution.

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