Qualer Cfr 21 Part 11 Gamp 5 Validation Service
QUALER CFR 21 PART 11 GAMP 5 VALIDATION SERVICE Qualer's was designed to meet the regulatory needs of GxP regulatory requirements of the Life Sciences and other regulated industries. Traditionally, the high costs of validation have caused companies to delay upgrades of business applications—often running three to four years out of date above the normally slow development cycles of legacy software applications. Qualer's validation services and multi-tenant cloud architecture reduce the overall time and effort companies spend validating applications. GAMP 5 Validation Library Authored and Executed by Qualer Qualer maintains 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 the following documents: 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 the system in a validated state. The User Requirements Specification The User Requirements Specification (URS) describes the business needs for what end users require from the Qualer system. Writing the URS is the first step in Qualer's development process. User requirements are tracked through our SDLC and are gathered together in this validation document prior to each release. The Release Risk Assessment Prior to the release of new functionality, Qualer performs a Release Risk Assessment (RRA) dictates the controls required for managing the defined risk of releasing new features and functions to our customers' regulated systems. This process follows Qualer’s internal risk management procedures (QM003-S Risk Management). This assessment intends to objectively identify the level of risk introduced by a
change to existing modules or workflows and guides the development of validation protocols to address that risk. The Functional Requirements Specification 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. The Software Design Specification 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. Installation and Operational Qualification The Installation and Operation Qualification (IOQ) protocol describes the testing methodology and test cases that provide the necessary documented evidence to assure that the Qualer has properly performed in accordance with defined system and regulatory requirements and Qualer procedures. These are the instructions our validation engineer follows to verify the installation and operation of Qualer end-to-end. Test Summary Report The Test Summary Report (TSR) provides the executed IOQ as performed manually by the validation engineer. The TSR is shows individually signed test cases, screenshots showing the results of tests performed, and the indicated PASS/FAIL for each test step. 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.
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. Traceability Matrix The United States Code of Federal Regulations does not specifically require a Traceability Matrix (TX), but creating a traceability matrix is recognized as a validation best practice. It serves as a map for auditors to review the test case coverage from individual user, functional, and design requirements to the corresponding test cases that verify the system's fitness for intended use. Support for Client Authored Validation Documents The Qualer team works with each validation customer to design their performance qualification utilizing a set of standard templates that cover: 1. 2. 3. 4. System Risk Assessment (SRA) User Requirements Specification (URS) Performance Qualification (PQ) - Protocol and Scripts Validation Summary Report (VSR)
Ongoing Validation Services Qualer releases platform enhancements three times per year to respond to the evolving needs of our customers. For each major release of Qualer , Validation Service customers receive a validation addendum that includes the full library of validation documents. We work 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. Updates are released as described in the following schedule: Weeks Prior to Deliverable Release 6 Weeks Release Announcement & Impact Assessment 4 Weeks Public Release Preview 2 Weeks Pre-Release Environment Access and Validation Documents 0 Weeks Validation Summary Report Description Feature list, compliance assessment, validation plan Public release announcement, sandbox environment access for customer evaluation of release features Controlled validation test environment access, validation protocol updates and addendums Executive report summarizing the release implementation and validation plan execution
Samples Below are brief samples of the validation documentation. A full review of the protocol is available upon request. IOQ Execution
Installation/Operational Qualification Protocol Audit Trail
Validation Summary Report TOC
Pharmaceutical Engineers (ISPE) GAMP 5. Our validation service is executed in accordance with GxP standards producing a validation library that features the following documents: Validation and Compliance Plan The Validation and Compliance Plan (VCP) defines the methodology, deliverables, and responsibilities for the validation of Qualer.
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37 CFR 1.55 has been filed in the instant patent application; and 3) any U.S. application-as-filed from which benefit is sought in the instant patent application. In accordance with 37 CFR 1.14(c), access may be provided to information concerning the date o f filing this Authorization.File Size: 803KBPage Count: 7Explore furtherApplication Data Sheet 37 CFR 1.76 (Paper Filed .www.formsworkflow.comForm-Fillable PDFs Available USPTOwww.uspto.govJustia :: Application Data Sheet (37 CFR 1.76) :: Official .forms.justia.comDECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN .www.uspto.gov37 CFR § 1.97 - Filing of information disclosure .www.law.cornell.eduRecommended to you b
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