How Logilab ELN helps organizations
to follow GxP Regulations
GxP is a set of regulations and quality guidelines formulated to ensure the safety of life sciences products while maintaining the quality of processes throughout every stage of manufacturing, control, storage, and distribution. Good Manufacturing Practices (GMP) – GMP are the guidelines recommended by agencies for the authorization and control of manufacturing of products such as drugs, medical devices, active pharmaceutical ingredients (APIs) etc. Adhering to these guidelines assure the agencies about the quality of the products and that the manufacturers have taken every possible measure to ensure the safety of the product.
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Importance of GxP Regulations
Since the regulations of GxP are global, every company manufacturing life sciences product is affected by it. Therefore, meeting the GxP requirements is highly important. Though there are several GxPs, few of them are highly important for the life cycle of any product. Good Manufacturing Practices (GMP) – GMP are the guidelines recommended by agencies for the authorization and control of manufacturing of products such as drugs, medical devices, active pharmaceutical ingredients (APIs) etc. Adhering to these guidelines assure the agencies about the quality of the products and that the manufacturers have taken every possible measure to ensure the safety of the product. Good Laboratory Practices (GLP).
Logilab ELN’s Role in GxP Regulations
The following features built into Logilab ELN will help laboratories and organizations to comply with GxP Regulations:
- User access control (with a unique username and password combination) i.e. Logilab ELN provides a closed system with restricted access. This is assured by secured system-login, which is unique for each individual Logilab ELN user.
- Role-based user access - User groups and project management
- Robust encryption standards
- Review and approval of data by assigned reviewers or approversds
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