System Design Specifications

Qualer CFR 21 Part 11 Validation Service Document

Qualer System Design Specifications

The Software Design Specification (SDS) describes the system elements, functions, and configuration necessary to properly operate the system within the functional requirements outlined in the FRS. By meeting the requirements outlined in this document, Qualer will correctly and reliably perform its intended functionality.

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.

Computerized Maintenance Management

Qualer Validation and Compliance Plan - 21 CFR Part 11 Validation

Qualer’s Validation Software provides companies with compliance and audit readiness by managing assets on one dashboard. Companies can view the current status of their assets and upcoming deadlines across their entire organization. Qualer’s software even provides Automated Computerized Maintenance Management for scheduling and asset compliance. Learn how to manage your assets with our computerized maintenance management software dashboard.

Qualer provides companies with software surveillance to ensure companies have a quality management system in place to pass ISO audits.

Qualer has a dedication and commitment to quality. With our end-to-end, responsive, and intuitive software, we are surpassing expectations and setting a new standard for quality asset lifecycle management software. Now your company can be prepared for an ISO surveillance audit. An ISO Surveillance audit is an ongoing period review of a Company's quality management system. (QS) The goal is to ensure an organization is continuing to comply with ISO Standards. For Equipment owners and service providers, quality means staying compliant and maintaining effective operations through the asset lifecycle. All without sacrificing time and peace of mind!

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
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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3
Operations Qualifications

Operations Qualifications

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

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4
Validation Summary Report

Validation Summary Report

The Validation Summary Report (VSR) summarizes the results obtained during the execution of the Installation Qualification Protocol.

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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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