Validation

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:

• Excellent Return On Investment (ROI) - Cost of compliance is low with respect to potential loss of intellectual property or other potential losses;
• Provides documentation required by FDA, other regulatory agencies, and your customers;
• Maximizes the value of the computer system and the employees that use it;
• Reduces labor costs by increasing employee efficiency and effectiveness;
• Enhances project management to ensure projects are implemented on schedule and on budget;
• Saves money by discovering defects early, before failures occur in production;
• Reduces risk. Legal liability, not regulatory, is often the most important reason to perform validation. Software is made and used by people so it is guaranteed to be imperfect. Software and process defects increase with software complexity. Having the evidence that computer systems are correct for their purpose and operating properly represents a good business practice;
• Promotes continual process improvement. Software is constantly evolving to keep up with the increasingly complex needs of the people that use it. Therefore, validation is an ongoing necessity;

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;

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.

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