Functional Requirement Plan

Qualer CFR 21 Part 11 Validation Service Document

Qualer Functional Requirement Specifications

The Functional Requirement Specification (FRS) details the capabilities and functions that the Enterprise Asset Management Software must be capable of performing. This specification provides general, as well as specific, requirements to be used in the design, validation, and use of the system. The focus is on what the system must do. By meeting the requirements outlined in this document, the Qualer system 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.

Maintenance Management Software Computer.

Real Time Compliance Alerts

Qualer Validation and Compliance Plan – 21 CFR Part 11 Validation

Qualer’s Validation Compliance Software alert engine strengthens the compliance accountability of each or your asset stakeholders with automatic email or SMS alerts. With nearly 60 available alerts, you can set 3 levels of notifications for your vendors, facilities, and team members, letting them know when your service events are due – days, weeks, and even months in advance.

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

At Qualer we know your job, success, and credibility depends on ensuring your organization’s assets are maintained in a state of control. Maintaining your equipment and completing your customer requirements requires time and effort you can’t afford to waste. The problem is that not every system you use offers a complete solution for staying compliant and keeping all your documentation in order. Qualer’s software provides, audit Trails, a fully validated system, and Equipment management centralization.

Lab Management Software Computer.

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.