Create Clearer Specifying Requirements with GAMP 5’s Appendix D1

No matter what GAMP 5 categories your software falls into, it’s critical that the software reliably meet your pharma organization’s expectations and goals for output within a planned system or device. This is why specifying requirements are critical.

Specifying requirements are a major part of the software development life cycle. When they are unavailable, not entirely accurate, or insufficiently detailed, the developer will likely deliver a product that fails to satisfy the organization’s real needs.

This is where standards such as GAMP 5 come into play. To guide the creation of accurate, sufficiently detailed specifying requirements that fully capture your process, pharma companies can turn to the 2nd edition of ISPE’s GAMP 5 Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized systems. The recently updated guide features a revised section, Appendix D1, that provides necessary guidance for helping pharma companies develop comprehensive specifying requirements.

How these merged GAMP 5 appendices impact you

Among the most notable changes within the 2nd edition of GAMP 5 around specifying requirements is the removal of the former Appendix D2. Instead, the appendices for User Requirement Specifications (URS) and Functional Specifications (FS) have been updated and combined into the single Appendix D1.

This is a significant change, but a move in the right direction there tends to be a thin line between URS and FS. URS is meant to provide a high-level view of the final software output, as compared to the more detailed performance requirements—the functions that describe how a system should operate—specified by the FS. This merger mirrors the overall GAMP 5 focus on users’ actions, which must precede or be included in later test case development.

Merging these two sections into a single appendix aims to make it easier for pharma companies to prevent documentation duplication. It also aims to streamline the requirements-gathering process.

There is still some guidance on functional design specifications, such as for custom systems in certain GAMP 5 categories, within the updated GAMP 5. This is covered in Appendix D3. The updated section Quality-Critical Requirements states that these requirements must be specific to an organization’s internal processes and policies and not generalized to “check a box” in meeting regulations. This specificity helps ensure the resulting software solution is relevant to organizations’ unique needs.

Specify solutions that meet unique organizational needs

This need for organization-specific processes is highlighted throughout Appendix D1. The early pages of 21.1.1, Changes from GAMP 5 First Edition, emphasize that the extent and detail included in the specifying requirements should be tailored to suit each business and how it operates. However, it also notes that basic tenets, such as traceability and good documentation practices, must be universally obeyed. Specifying requirements should explain how these basic tenets depend upon the type of system being specified.

The revised Appendix D1 also includes updates that account for Agile development methods. The Agile process of development allows for creativity and the development of new ideas over time. This includes innovation driven by technology solutions. The updated appendix also accounts for the increased use of technology tools and automation that can capture and define requirements. While paper-based and other manual processes must be referenced when necessary, the increased shift to technology-based requirement gathering allows pharma companies to move toward more efficient and less time-consuming processes.


Pharma companies need to invest ample time into developing specifying requirements. This upfront time and effort will help ensure that the final product meets all requirements. With accurate input, organizations can be assured of reliable output.

To further streamline this process, many pharma organizations turn to a partner knowledgeable in the process of implementing new technology solutions. GxP-CC can help your organization determine the best way to implement, regulate, and protect new technology. Contact GxP-CC today to learn more.

For additional insight into GAMP 5, 2nd edition, changes, visit the GxP-CC blog.

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