Validierung

SoftExpert Validation Toolkit

It takes some pretty expensive knowledge and specialized skills to create compliant validation documentation. We help you do it comprehensively and cost effectively.

SoftExpert Validation Toolkit is a detailed collection of templates, validation test protocols, forms and scripts designed to help your validation project team members complete the requirements for validation projects. The toolkit consists of project-level templates of validation documentation items such as User Requirements Specification (URS), Functional Requirements Specifications (FRS), System Acceptance Test Plan and other valuable documents.

About Installation and Operational Qualification Protocols

SoftExpert has developed predefined protocols covering all aspects of the Installation and Operational Qualification requirements. The IQ/OQ protocols allow the manual execution of validation efforts in just a few days versus the lengthy task of program engineering review and self-creation of protocols that an off-the shelf or homegrown system would require.

About User Requirement Specification

Although each organization will likely have a unique User Requirements Specification (URS) based on its own operating policy, quality directives, validation needs and regulatory requirements, a generalized URS structure is self-contained in the toolkit. This structure can assist in development of a custom URS or can be adopted where special and/or additional requirements are unnecessary.

Should your organization decide to perform the SoftExpert applications validation itself, SoftExpert Validation Toolkit will enhance your process productivity.

Customer Benefits

• Standard documentation in full adherence with SoftExpert applications.
• Firm understanding of solution requirements and market standards.
• Full adherence to GAMP (Good Automated Manufacturing Practice).
• Makes the SoftExpert application validation process quick and easy.
• Guarantees data legitimacy and conformity.
• Enables efforts to be concentrated on high value added activities.

Main Activities

• Provide project-level documentation with SoftExpert application standard scenarios.

Main Deliverables

• User Requirement Specification
• Functional Specification
• Hardware Specification
• Network Specification
• Design Specification
• System Acceptance Test Plan
• Master plan for computer system validation.
• Computer system validation plan.
• Computer system validation strategy.
• Computer system validation policy.
• Computer system validation objectives.
• Identification of systems for validation.
• Vision for computer system validation.
• Systems validation team.
• Computer system validation deliverables.
• Computer system validation responsibilities.
• Request for change.
• Validation training record.
• Incident record.
• Cost Control.
• Installation Qualification Report.

Protocol Execution Services

If you don’t want to go it alone, a SoftExpert consultant can guide your test team through every feature and function of SoftExpert applications. These services were specifically designed to help companies with limited validation experience or insufficient manpower to rapidly execute the validation test scripts.

The protocols are based on industry standards and provide full traceability back to the feature definitions of the product’s Functional Requirements Specifications. They contain all of the necessary guidelines for both full validation and re-qualification testing for systems upgrades.

IQ Execution

The Installation Qualification execution services may be conducted either remotely via secure Internet connections or at your site. In both executions, our consultants will lead your personnel in the inventory and installation check of your server hardware to ensure it meets the necessary requirements for systems operation.

OQ Execution

The Operational Qualification execution services are conducted manually at your location using SoftExpert’s protocols to test and execute the various functions and operational features of the SoftExpert application. Our consultant directly assists your personnel in the completion of the protocol test activities throughout the OQ process. Upon test completion, the finished protocols, test execution notes and collected screen shots become the objective evidence of the system performing to the functional design.

PQ Execution

Our consultant assists in the execution of the protocol test instructions, providing overall guidance and leadership during the implementation to ensure proper records and testing compliance.

Customer Benefits

• Availability of professionals highly qualified in the solutions to be validated.
• Firm understanding of the FDA 21 CFR Part 11 standard requirements.
• Availability of a mature professional team experienced in software validation processes.
• Documentation standardization.
• Guarantee of record legitimacy and conformity.
• Use of processes, tools and methodologies compatible with current market trends.
• Realistic and clearly defined expectations.
• Cleary defined deliverables and results.
• Very precise information for decisions at all levels.

Main Activities

• Align expectations with the customer.
• Provide necessary documents and materials (specifications), for increasing process specifics.
• Define and apply qualification methods (Installation Qualification, Operational Qualification and Performance Qualification).
• Execute test scripts.

Main Deliverables

• Executed test scripts.