Software configurable

Category 4—Configurable Software Packages These software packages can be conhgured according to user requirements. A supplier audit is usually required to conhrm software has been developed according to a documented quality system. Validation should ensure software meets URS requirements. Full life cycle vahdation is needed. [Pg.305]

Configurable software packages—validation life cycle with qualification of the hardware and application software... [Pg.578]

Supplier of the Standard/Configurable Software Packages used and/ or the System... [Pg.34]

Configurable software packages, (e.g., LIMS, SCAD A, building automation systems)... [Pg.39]

Configurable Software packages are also called custom configurable packages. [Pg.85]

The software system and hardware platform must be well known and mature before being considered to be Configurable Software otherwise the software validation activities for Custom-Built systems must be used. [Pg.85]

A typical feature of configurable software packages is that they permit users to develop their own applications by configuring/amending/scripting predefined software modules and by developing new application software modules using the standard (core) product. Each application (of the standard product) is therefore specific to the user s process and maintenance becomes a key issue, particularly when new versions of the standard product are released. [Pg.85]

When purchasing configurable software, it is often the practice to evaluate the criticality of the application to the regulatory operation, in order to determine if a supplier evaluation is warranted and feasible. If a supplier evaluation is not warranted or feasible, the rationale for this must be documented and retained with the system validation documentation. As in the previous case, the end user is responsible for ensuring that the program is suitable for its intended purpose when used in a regulatory environment. [Pg.120]

Configurable software Application software, sometimes general purpose, written for a variety of industries or users in a manner that permits users to modify the program to meet their individual needs (FDA). [Pg.179]

GAMP Category 4 Software Configurable Software Packages... [Pg.140]

The computer system uses a purchased custom configurable software package. The software validation documentation failed to adequately define, update, and control significant elements customized to configure the system for the specific needs of the operations. [FDA Warning Letter, 2001]... [Pg.191]

As LIMS are basically configurable software packages, the quality of the design, coding, and documentation by the supplier is critical to obtaining an acceptably validated LIMS. The LIMS suppliers have developed an appreciation for the unique requirements of the pharmacentical industry, and the last few years have seen an improvement in the system development fife cycles used by some suppliers. Therefore, a thoroughly documented evaluation of the snpplier s practices forms a fundamental part of the validation of LIMS. [Pg.513]

Configurable Software Chromatography data system package... [Pg.674]

Category 4 (data system configurable software) Base test case development on function risk assessments leverage as much supplier testing as possible. [Pg.678]

The second phase is the installation of the configured software. This is also little different from a standard IQ for information management software and may include checks on the following ... [Pg.773]

Configurable Software Consider audit, validate application, and any bespoke code. [Pg.885]

One approach to automate the way of electronically requesting information from other software systems is the concept of service requests, which are mechanisms to create definable requests for external data. Service requests are predefined by key users of the systems, whereas the end-user simply calls a wizard for one of the predefined service requests, fills out the data required by the external software, and sends it to the target software. The wizard application translates the request to XML format, which is typically understood by the SDK of external software. Results from a service request are automatically converted, parsed, and transferred to the inbox by use of configurable software agents. [Pg.328]

Settings (switch settings, firmware configuration) Software versions (including third Approved GxP Assessment Report Approved Source Code Review Report... [Pg.170]

Layer 7 network configurable software packages relate to GAMP category 4 software. [Pg.318]

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