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Quality Control
- Record, manage, and query donor and specimen screening
- Interface directly with your devices and Laboratory Information System to pull all lab values on the patient, specimen and/or product directly into StemLab™
- Enforce operational sequencing with the ability to include forced data entry prerequisites, supervisor review status and record lock following final approval
- Document deviations, complaints and other events and link to a full CAPA system
- Access electronic standard operating procedures (SOP's) or link to a full document management system
- Perform ad hoc queries and generate customized reports for outcome analysis and ongoing quality assurance information reviews and audits
Processing
- Record and track all your processing steps, such as freezing, thawing, and culture methods
- Standardize processes through protocol driven procedures that track collections, manipulations, segments and products
- Easily manage and record the cryopreservation of multiple products from a single source
- Create worklists that allow users to easily navigate to multiple products from various donors
- Interface to your devices to eliminate duplicate data entry and errors
- Generate and print bar-coded labels for all your products
- Coming Spring 2008! Generate ISBT-128 labels for all your products
Specimen Inventory/Storage
- Customize freezer configurations and easily track product and related specimen inventories
- Easily retrieve specimens based on user-defined search criteria and bar codes
Consumables and Equipment Tracking
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Keep detailed records pertaining to all consumables and equipment used by your lab
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Track all consumable and equipment information and relate each use to individual product manufacturing processes for lot to lot traceability
- Ensure the ongoing maintenance and calibration of your equipment and generate maintenance reports for QC
Outcomes
- Track clinical outcomes such as intervention or procedural success rates
- Track specimen quality
- Research and relate changes in practice to specific clinical outcomes
Reporting
- Report on any piece of information captured in the database to meet laboratory accreditation requirements
- Produce post-thaw donor specimen reports
- Review audit trail reports of when and by whom data was entered or changed
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