Validation Deviation Summary Report

Qualer CFR 21 Part 11 Validation Service Document

Qualer Validation Deviation Summary Report

The Deviation Summary Report (DSR) documents any test steps from the IOQ that do not match the expected results, or it indicates that no deviations occurred during validation. The report outlines the root cause of the deviation and lays out the steps required to address and close each deviation.

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.

Accurate Asset Measurements

Qualer Validation and Compliance Plan - 21 CFR Part 11 Validation

Qualer’s Compliance Management Software ensures total compliance and audit readiness by managing all of your assets on one, easy-to-use dashboard. With the ability to view the current status of your assets and upcoming deadlines across your entire organization, you can easily take action on upcoming items to remain in a state of control. This allows Qualer’s software to easily track if a deviation has occurred through the validation process.

Qualer’s cloud based compliance software solution provides real time, on the go access, underneath one digital dashboard.

Qualer provides cloud-based validation compliance software. Qualer’s Compliance Management Software offers real-time, on-the-go access to every part of a business. Technicians can access your system at any time and location, even without internet access. See what’s happening in every area of your business in real-time, on one digital dashboard. Now your company will be able to view job statuses, new work orders, tech information, asset profiles, and specifications under one system.

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 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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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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