According to the "General Principles of Software Validation; Final Guidance for Industry and FDA Staff ", validation is the "confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled".
The more complicated state and federal regulations become, the more challenging it becomes for life science companies and their system administrators to utilize computer systems in a fully compliant manner. Today, meeting the requirements established for the performance of your computer systems is not a task easily handled.
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.
Benefits of Computer System Validation include:
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.
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.