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See typical requirements and implementation steps you’ll need to implement a LIMS
Before you can implement a Lab Information Management System (LIMS), you will need to define your user requirements. Especially in a GxP environment, having a clear understanding of how you want the system to operate will make it easier to select a preferred a product, and to validate it for implementation.
Typical user requirements will include quality goals that define how user roles are managed, security is maintained, and data is retained. Here is a snippet of SciCord’s typical recommended quality requirements:
| UR-Qual-01 | The system manages user roles for at minimum Administrator, Scientist, Data Reviewer, Sample Manager, Customer, and Quality Assurance. |
| UR-Qual-02 | The system supports granular permissions for system functionality. |
| UR-Qual-03 | The system manages a matrix of roles versus permissions. |
| UR-Qual-04 | The system manages User definition – creation, activation, updates, deactivation, and role assignment. |
| UR-Qual-05 | Grouping mechanism, such as the “site”, which governs the default scope of information displayed to a user. Site scope may be overridden to display a wider range of information. |
| UR-Qual-06 | A mechanism must be available to expose specific information or documentation to internal or external customers |
Additional requirements will be required to cover specific functions – document editing and lifecycles, sample management, review, reporting, user interface, etc.
Requirements will vary based on your needs, but SciCord provides a full typical requirement set if you need a robust starting point:
After you’ve written requirements, you’ll need to identify the vendor and product that best meets your requirements. After purchasing, your selected system will need to go through validation (if you are GxP) and implementation.
If you need assistance selecting a vendor, we have a full Buyer’s Guide available. This guide also covers post-purchase activities (implementation and maintenance).
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Senior Pharmaceutical Scientist
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