For cloud solutions we work exclusively with our partner Loftware and their NiceLabel Cloud products. This belongs to the various cloud subscriptions and also the local Label Management Software products.
Process validation in regulated companies
To ensure product quality, regulated companies have to comply with many complex specifications from national or international standards, laws and guidelines. The choice of software plays a major role and has a significant impact on the validation effort and the associated costs. The GAMP-V model is an established procedure for software validation in several project phases.
The validation plan for an IT system is mandatory and defines the user requirements (URS). The identification and description of technical requirements is defined in the functional specification (FS) and implementation is specified in the design specification (DS). Once the system has been coded, it is installed and configured according to the installation plan (IQ). A basic acceptance test is carried with test data (OQ) and after successful completion, the final function and acceptance test is approved with productive data. All these steps are checked against each other and documented in detail, which represents a large part of time and cost.
Version management for documents
While version control is a useful extension for product labeling, it is a mandatory part for regulated companies. All adjustments to documents must always generate a new version and only the last released version should be available for printing in production.
An important part of the version control is the correct assignment of access rights of the respective persons or groups. In addition to approving documents, these are also important when deactivating and downgrading documents.
Differences in detail
In the workflows for the approval of documents, it is often not easy to control small adjustments. This includes adjustments in font sizes, minimal changes in positioning and the content of barcodes. For a correct release of changes, these must be checked and the information in the release request is often not detailed enough.
The function for visual version comparison of any versions in the life cycle of a document provides this extrem useful feature. The versions to be compared can be selected and the differences are marked in the comparison view.
Workflow status in the document
Depending on the selected workflow, different steps needs to be done to approve a document. The current status can be shown directly in the document itself, including the previous steps. This also applies to documents that have already been approved in order to get an overview of the approval process.
Additional the label report offers more detailed information on changes in the layout. There you will find the print preview and general data on the layout as well as the workflow steps that have been done before. In order to evaluate field content, extended information such as font size, font, barcode type or picture name is available for all field types (text, images, barcodes ...).
The advantage of standard software
For software that can be configured, but is used in its standard configuration without adapting to specific business processes, there is GAMP Category 3 with simplified validation. If this is the case in the cloud solution or LMT version, there is the Validation Acceleration Pack with ready-made documents to support the validation for the standard software.
It is important here that the modules such as PowerForms or Integration and Automation are almost always tailored to specific business processes. In this case, category 3 quickly becomes category 5 with considerably more effort in the valuation.
Validierung via Professional Service Group
For the LMS and cloud solutions that require validation, there is usually already a team that is familiar with the validation of business processes. Our Professional Service Group can provide support in such cases and rely on experience from previous validations. This can significantly reduce the amount of work involved in such tasks.
Even if companies want to pass on a larger part of the validation or even the complete preparation for a validation audit to the Professional Service Group, we would be happy to discuss this in a meeting.