Trying to maintain a record of all the changes that SAS programs undergo as part of any development effort without a source code management system can be a daunting task. Developers are often faced with either the time-consuming effort of using convoluted change management procedures or bypassing the detailed versioning of their code for expediency sake. Either way, valuable information about the history of SAS programs is either lost or not maintained in a cohesive, methodical fashion. If a record of the changes exists, it is frequently only because complex processes, procedures, and policies must be adhered to.
Without tools to help manage the versioning process, costly manual procedures must be used to keep a record of changes. Often overlooked with any recording mechanism is not only what has changed, but who made the change and when it was performed.
Given that SAS is widely utilized to support clinical trials, and subject to regulatory scrutiny, it is imperative that accurate records be maintained in the development life cycle of SAS programs.
STS has put together an offering that addresses the shortcomings or absence of manually maintained change control methods. It is based on an industry recognized and time-tested source control management system called SubVersion, or SVN for short. SVN stores all data consistently in a central data repository. SAS programs and other data elements and files are “checked-out” when changes need to be made. Once changes have been tested and signed-off, the new version of the program or file is “checked-in” along with a record of the change and who made it. Other than the check-out/check-in process, changes to the programs or other data is done exactly as now. The SAS Version Control solution does not add needless overhead or create undue burdens to developers.
Using a version control system adds discipline to the process by which SAS programs and other files related to a project or clinical trial are maintained and stored. Consistency can be established in how programs and other data is stored, accessed, retrieved, and updated.
The importance of having accurate records and an audit trail of changes is becoming increasingly important in today’s environment which requires a complete accounting of work performed. Our Version Control solution provides this demanding level of accountability.
Key to all of this, however, is a system and methodology that minimizes infringing on the development process. That is, any source control management system should not become so “heavy” that it creates undue burdens to developers. Our Version Control solution is streamlined to minimize the impact of working day-to-day with SAS programs and other files.
The use of SubVersion in SAS programming environments provides a mechanism by which regulatory compliance can be achieved, specifically for portions of section 11.10 of the regulation, which deal with audit trails, code and data revisions.
The version control capabilities provided by Subversion are freely available, but it is only a tool. The benefit of that tool is in how it will be implemented and used. STS provides the installation, configuration, and implementation services to help an organization get started with version control and get them up and running quickly. STS does this by:
STS can work with you to determine the most advantageous way to implement SubVersion. We provide you a framework and configuration as a starting point based on our experience with SAS and work with other life science customers. It can be installed on your hardware running on your choice of Windows or Linux operating systems. Alternatively, it can be hosted with our partner, Validated Cloud, whereby you are not burdened with maintaining the SVN server. We can also provide ongoing support in a managed services model thereby providing you complete turn-key support.