Qualer Validation & Compliance Plan

Qualer 21 CFR Part 11 Validation Service Document

Qualer Validation and Compliance Plan

The Validation and Compliance Plan (VCP) defines the methodology, deliverables, and responsibilities for the validation of Qualer. The VCP also describes criteria for final acceptance of validation deliverables and system release, as well as the controls that Qualer has in place to maintain the system in a validated state.

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.

Digital Signature Validation

Qualer Validation and Compliance Plan - 21 CFR Part 11 Validation

Qualer provides a solution with a singular focus: shaping the future of asset health. Qualer’s Validation Compliance Software takes the guesswork out of asset management, giving companies the digital validation they need to pass regulatory audits. Qualer’s collaborative ecosystem connects all assets and services providers to manage the lifecycle of critical assets on one dashboard. Qualer empowers all users to communicate seamlessly under a single platform, creating alignment, and making sure everything stays compliant and on schedule.

Qualer provides a pre-configured business-in-a-box, best in class, software solution for companies in need of 21 CFR Part 11 Compliance

Qualer's Compliance Management Software provides auto calculation of measurement uncertainty, with their live ISO 17025 CMC validation. Companies are now capable of managing the measurement data, and performance specifications with specification libraries. Qualer’s cloud infrastructure enables calibration and documentation to be processed in real-time. Qualer’s software digitally completes calibration reports, and generates certificates and labels.

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
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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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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