Guarantee the use of electronic technology instead of high cost, time consuming paper systems. This is the objective of the validation services offered by SoftExpert.
As part of our methodology, we provide confirmation by examination and provision of objective evidence that your computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled in a regulatory compliant manner.
The Validation Services are evidence of SoftExpert solution conformity with the FDA 21 CFR part 11 regulations. This ensures that electronic records and signatures are considered as trustworthy, reliable and legally valid as paper records.
System Acceptance Test
The System Acceptance Test service provides application acceptance to ensure conformity with the specified technical and functional requirements.
The application acceptance process is based on a functional test plan, prepared in advance, which gives the customer a better understanding of the contents, structure and mechanism of the test. It also contains the necessary details to guarantee the test can ensure the application meets the requirements, if it is stable and whether or not the new functions or modifications affect the existing functions.
The test plan contains standard system function/resource scenarios. The drawing up of specific customer scenarios and test execution mentoring with users performed by a SoftExpert professional can be acquired separately with consulting services.
- Prior identification of how to deal with the requirements.
- Clear identification of acceptance criteria.
- History of test execution results.
- Assurance that application adheres to the functional requirements and to the company's business.
- Provide standard functional test plan per application.
- Draw up specific functional test plan, according to customer needs and requirements. (*)
- Follow test plan execution with the customer's system users, as well as draw up and provide a report showing results of the tests performed. (*)
- Standard functional test plan per application.
- Specific functional test plan. (*)
- Test plan execution record with report of obtained results. (*)
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.
- 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.
- Provide project-level documentation with SoftExpert application standard scenarios.
- 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.
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.
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.
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.
- 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.
- 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.
- Executed test scripts.