Azenta Life Sciences Services utilizes Inventory Management Systems to track our customers material within our facilities and associated sample data beyond storage. Systems are FDA 21 CFR Part 11 compliant and utilize audit trails to ensure data integrity is maintained.
Azenta Life Sciences Inventory Management Systems include electronic audit trails, workflows for sample receipt, accessioning and Retrieval (for shipment or destruction requests) and tracking of relationships between parent samples and aliquots.
Systems are flexible in identification of materials and can accommodate client's preferred bar-code nomenclature or custom labels to improve sample tracking.
Project specific information is maintained by Azenta Life Sciences (method dependent on site where service is provided) to allow for consistency in storage amongst common protocols or material types as specified by our clients.
Data Management Services allow for association of material data with inventory data via Azenta Life Sciences built manifest or client provided data file.
System reporting technology allows for custom data reporting to support improved data analysis.
Azenta Life Sciences can retrieve, package and ship materials for next day delivery (amounts dependent on site where service is provided and client-service agreements.) Samples are destroyed only upon client's written request. The requestor must be an authorized project contact.
Globally, Azenta Life Sciences has more than 160,000 square foot of storage area. At each facility, equipment is maintained in volumes appropriate to current and forecasted work.
For each type of equipment, appropriate test cases are developed, and a revision-controlled validation protocol is created and executed (SOP 3000-3001, Validation Master Plan). Equipment qualification is performed by appropriately trained personnel. In addition, a member of Quality Assurance acts as the final reviewer of all testing.
Storage Environment Temperatures are recorded and monitored 24-hours a day by validated remote alarm systems. As soon as a predefined temperature range is exceeded for (defined in temperature monitoring procedures) appropriate personnel are informed via email and call. Temperature monitoring procedures include alarm response requirements. Outside of business hours a dedicated, trained On-Call Team is available to immediately respond to any storage environment or maintenance alarms or other emergencies.
- In case of power failure, Diesel-powered generators provide back-up electrical power to the facility and all temperature critical equipment.
- All storage environments and alarm systems are maintained on a prescribed basis per SOP utilizing guidance from the equipment manufacturer.
- Azenta Life Sciences utilizes redundancies in the form of empty, fully qualified back-up storage environments in case of environment failure.