Quality in the Life Sciences Industry is important. Regulations are strict to ensure the health and well-being of consumers. The norm is to hold organizations accountable for the quality of products and processes as much as is possible. A norm that is enforced by FDA, EMA and other regulators e.g. through inspections and audits. On top of that, organizations generate their own quality-related events through their trained staff or through customers. Quality is in the DNA of every Life Science employee and all Life Science organizations need a way to manage that quality.
The question is: which way? The answer for the Life Science Midmarket is EQMS Light!
Integrated with EMC's Life Sciences Suite
Where other EQMS solutions live next to an eDMS and make it difficult to control the attached documents, EQMS Light is an integrated additional module for EMC’s Life Sciences Suite. This provides these benefits for you:
- ‘Attached’ documents don’t leave the controlled environment; they are just linked to the quality record in a fixed state (a particular version) or a current state (the latest version);
- Impact analysis of affected documents is intrinsic; the eDMS already knows which documents are related to each other and a quality record becomes just another related information item;
- All documents that are created as a result of a quality record, are managed as any other controlled document. This includes standard functions as version control, access control and workflow automation;
- Re-use of the vocabularies, dictionaries and taxonomies that come with EMC’s Life Sciences Suite;
- Single validated environment.
Fit for Purpose
EQMS Light is not designed to meet the needs of the large Life Sciences enterprises that work with enterprise sized budgets. The result is a lean solution that fits its purpose and just that. Where other EQMS solutions provide additional functionality e.g. to support the new training and education regulations, EQMS Light is focused on just the quality records. It leaves e.g. training and education needs to dedicated solutions that are already available on the market and can work with EMC’s Life Sciences Suite like the Learning Management System ‘LMS365’ from eLearningForce.
Easy to use interface
Creation profiles support the user in selecting the appropriate quality event. All events are classified in a category – subcategory structure. For example, a Supplier Deviation is a subcategory of Deviations. Based on the assigned role, the user can only initiate those quality events that fit the permissions for that role.
Once the quality event has been chosen, information needs to be provided. Some information is mandatory, some is optional. When available, existing information will be populated automatically. Where relevant, the user is supported through selection lists that are prepopulated with all possible values for this event.