At Dashe & Thomson, we take a partnership approach to helping you validate your software systems according to FDA regulations. Our proven methodology ensures:

• A fully compliant, first-pass validation
• Rapid completion, without interference to the system implementation
• Lower implementation costs while adding value to the organization

Our goal is not only to help you validate individual systems, but also to assist you in developing an internal methodology to allow you to validate future systems on your own, efficiently and accurately.

Because the level of validation effort should be commensurate with the risk posed by the system, it is very important for you to thoroughly understand the functions of the new system, assess risks of the system on the integrity of the production or quality system, then create a validation plan which accomplishes compliance—yet doesn’t create an over-burdensome effort. This is where Dashe & Thomson’s experience in software validation can save you valuable time and resources. Our proven planning methodologies and our tool kit of validation templates, procedures, and policies give us the ability to ensure your company a smooth, cost-effective validation solution.

Dashe & Thomson’s validation consultants guide your project team members through the creation and approval of all key deliverables for a system validation:

• Master Validation Plan
• Implementation Risk Assessment; 21 CFR Part 11 Compliance Assessment
• System Change Control Policy, Process and Procedures
• Documentation of protocols for the Installation Qualification (IQ), Operational Qualification (OQ) and the Performance Qualification (PQ)
• Execution of and final reporting on the IQ, OQ, and PQ
• Traceability Matrix and Final Letter of Certification

We also can provide a wide array of validation training materials, from high-level summaries for executives, to detailed procedures for system testers or writers of requirement documents. And our extensive experience in developing end-user documentation, training, and test plans for software systems will add value to your entire organization. Our unique methodology can re-purpose common elements in required validation documents (such as user requirements, functional requirements, and test scripts) into user training plans, lessons, and reference guides. This reinforces our mission to save our customers time and resources in both the validation and overall implementation processes.

FDA Software Validation PowerPoint
21 CFR Part 11 PowerPoint