SOLABS QM is a fully integrated Enterprise Quality Management System (EQMS) software solution developed specifically for Life Sciences companies. Our EQMS allows companies to manage Controlled Documents, Quality Business Processes (Quality Events, CAPA & Investigations, Audits, Change Control, and Calibration & Maintenance), and Employee Training Records all in a single interface.
Can accommodate anywhere from 15 to 5,000 users.
Complete EQMS in a single application/user interface.
Over 5,000 active users in various regions of the world, with continuous R&D investments for over 10 years.
Companies can start by using specific functional areas of SOLABS QM and then expand to a completely integrated EQMS.
The user interface is intuitive and standardized across all functional areas.
The application is accessible from anywhere provided you have an internet connection and VPN access.
Enforces internal collaboration by alerting employees of their assigned tasks both in the user-driven homepage and email notifications.
Allows for creation of external users with limited access to specific information and actions for collaboration with partners.
Built using enterprise software standards, web services and APIs. Integrates with platforms such as: SAP, Labware, Microsoft Dynamics, Great Plains, NAV, Siebel, Salesforce, Oracle, etc.
Seamless integration with eCTD software to allow publishing of ‘Approved and Effective’ regulatory documents exported from SOLABS QM. More information on our official partner: Lorenz Life Sciences
Our ‘training-only’ user category makes the system accessible to all employees with a non-prohibitive pricing model. These accounts have very limited access to the system and the capabilities within.
Extensive and integrated reporting capabilities come as part of the standard software package.
The system uses a business process engine to assign and monitor tasks per user. Users are held accountable as the system can block the process until tasks are completed.
Web forms can easily be filled out to report Non-Conformances and Deviations using handheld devices. Controlled ‘Approved and Effective’ documents can be published to tablets.
Currently available in 4 languages: English, French, Spanish and Japanese.
Determine the document type and create the associated attributes (metadata).
Authors and collaborators create and format documents. This step ensures content is ready for approval.
Distribution of internal and external copies. This includes all printed copies, electronic copies sent internally, or copies sent to suppliers, partners, etc.
This is where 21CFR Part 11 has the greatest impact. The audit trail entries are created and the ‘regulated’ history of the controlled documents begins.
Document Change Control allows for management of all requests from their initiation to being set effective with active monitoring of related training activities (if any).
Change requests can be configured to automatically initiate a set number of months before the next review date on a per document basis.
User access rights must be controlled and reviewed periodically.
If required, employees may be assigned training in relation to a controlled document. The system will ensure all training is assigned and completed before setting that document as ‘Effective’.
The document is set as ‘Official and Effective’.
Retiring involves the decision to retire a document or a group of documents no longer needed. For example, when an instrument or equipment is no longer used, its documentation may be retired. Retired documents remain accessible.
Archiving involves a set of rules to store documents or supersede document versions outside of their initial creation system. These documents also remain accessible.
Reporting is an important feature in order to appropriately follow-up on the flow of ‘In Process’ documents. Reporting enables periodic extraction of information on cycle times per department, users’ performance in review, approval cycles and more.
Create training activities and determine the associated settings such as recurrence, related training activities and completion requirements.
Easily assign training activities to end-users based on job title profiles. This can be done automatically during document review.
SOLABS QM’s reporting capabilities enable training administrators and managers to easily follow-up on training activities.
An official record of completed training activities is maintained in the system and is accessible to managers.
Easily add or remove activities linked to a given job description thus creating job title profiles. Activities may also be assigned to end-users in bulk and specific due dates may be set for completion per activity, a function extremely useful when new employees are hired or when employees return from an extended leave of absence.
Assigned employees are notified by email, on their SOLABS QM homepage and on their personalized ‘My Profile’ page of training they are required to complete. Managers can also be notified that their employees have training assigned.
Also provided is the ability to create online training assessments. Users can need to successfully complete this assessment before being considered as trained on a given activity.
Once assigned employees have completed the training activity and fulfilled the completion requirements, training is recorded as completed. Failed training activities are automatically reassigned to end users.