UDS Services

We addressing to the millions of businesses that have yet to realize the benefits of digital document management, and as a result, have an enormous opportunity to improve their efficiency, productivity, and profitability.

Organizations with an overarching system in place to handle all their information operate at a vastly superior level of efficiency compared to those that still rely on paper files and folders. Even companies with most of their documents in digital form, but in a traditional folder structure, suffer many of the same drags on productivity as paper-filing systems. Time is wasted constantly looking in several folder locations for misplaced documents. This is often compounded by the proliferation of multiple versions of the same file that results in errors and repeated work. Without a document management framework, businesses find it very difficult to enforce reliable file organization and optimize their internal processes.

We believe that a comprehensive document management solution should neither change peoples’ daily work routines, nor require a lengthy or costly implementation. In our experience with thousands of customers, we have found that nearly any organization can significantly improve its bottom line with easy and affordable document management.

A Computer System Validation is a set of activities that FDA Regulated companies must conduct for each of their GxP sensitive computer systems. The objective of these activities is to document evidence that each computer system will fulfill its intended purpose in a GxP production, laboratory, or research operation. The intention is to avoid software problems that could have serious impact. Dynamic testing of the software is an important part of the Computer System Validation. But Computer System Validation is more than just this type of testing. Computer System Validation requires a comprehensive set of equally important static testing activities that need to be conducted throughout the SDLC. This includes a variety of analyses, audits, walkthroughs, reviews, and traceability exercises. Documentation must be accumulated that demonstrates that these activities have been performed effectively.

Today, the term Computer System Validation refers specifically to the technical discipline used in the Life Sciences sector to help ensure that software systems meet their intended requirements. Through its regulations/guidance on Computer System Validation, the FDA has shaped IT testing and analysis processes to match the needs and requirements of the industries it governs. As a result, Computer System Validation has become an integral part of doing business in FDA regulated environments. It should be noted, however, that significant progress has been made in achieving consistency and harmonization between FDA regulations/guidance on Computer System Validation and relevant international IT standards and best practices. It is likely that the future will see convergence of Computer System Validation terminology and techniques as a common technical discipline across other industry sectors as well.