![]() Then a "mix and match" approach could be used. the functions that will be configured for your business processes vs. Suppose you are able to clearly delineate which functions will be used in their native state vs. Using bespoke workflows and features would elevate the SharePoint instance to Software Category 5. For example, custom workflows and/or scripts may be designed and used. If specific configuration of out-of-the-box functionality is insufficient to meet business process needs, it may be necessary to customize SharePoint for the management of regulated content (e-records). In this case, SharePoint is configured to meet business process needs and, therefore, would be considered as a Software Category 4. More importantly, certain functionality (such as information management policies, auditing, and versioning) must be configured if SharePoint is to be used in a 21 CFR 11 compliant manner for the management of regulated content (e-records). ![]() Category 4Ĭertain SharePoint functionality can be configured (activated/deactivated, enabled/disabled) above and beyond what is offered in a vanilla deployment. Even if it did, the intended use of this SharePoint instance would probably not have any regulatory purpose that would necessitate validation. In other words, it is improbable that SharePoint would fall under this category. In its vanilla version, SharePoint would serve as a collaborative workspace only and would not be very useful for the management of electronic records that are subject to the regulatory restrictions of predicate rules because functionality for versioning, audit trails, and record restrictions are not enabled by default. With the default settings, SharePoint offers limited functionality that is of interest to regulated users. To consider SharePoint as Software Category 3, it must be used “out of the box”, without any configuration, as a collaborative environment and document repository. ![]() Then, you can use the following rules of thumb for choosing the appropriate software category. It is important to evaluate whether SharePoint can meet your business requirements “out of the box” or if any configuration or customizations are needed. Next, you need to reflect on how you intend on using SharePoint to accomplish your business activities. Selecting a Software Category for your SharePoint application These categories progress from simple, low-risk systems to complex software with increased risk of system failure. So how do you go about selecting the right GAMP® 5 Software Category for your SharePoint application? Here are some guidelines to help you decide.įirst, let’s define the Software Categories within the GAMP 5 Guidelines. GAMP® 5 defines Software Categories that may be used along with risk assessments and supplier assessments to develop a suitable and streamlined validation strategy for your software application. Within the validation world, one of the most adopted guidelines is GAMP 5. Much like any process improvement, the secret to reducing timelines and ultimately cost is in the design of the process and the structure of the activity, as well as adopting forward thinking guidelines to reduce bottlenecks. With a heavy price tag, computer system validation professionals are often pressured to reduce these budgets and deliver validated systems in a shorter time, with less resources while still maintaining quality and compliance. ![]() Computer System Validation has traditionally been considered a lengthy and costly process, with significant budgets being allocated to validating electronic systems in the life sciences – and in some cases for good reason. ![]()
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