With over 60 years combined experience specifically in the fields of specimen storage, cold chain logistics and most specifically regulatory compliance, LegalSafe is able to offer the depth of knowledge that you require. LegalSafe’s extensive experience with over 140 law firms ensures compliance to all court-ordered protocols and strict client/patient confidentiality.
The team at LegalSafe has the knowledge to consult with you on your project and we fully understand the challenges and intricacies associated with sample storage, specimen management and cold chain logistics.
Our quality of service is primarily built on the knowledge that our team possesses. From this knowledge and industry experience we have built 64 Standard Operating Procedures (SOP’s) which control all aspects of our business including Facility Management, Quality Management, Equipment Management, Controlled Substance Management and Sample Management.
These procedures are essential to maintaining compliance with all regulatory bodies and our clients’ stringent requirements. Our daily business practices are incorporated into the SOP’s along with the regulatory requirements to guarantee proficient procedures. The SOP’s are the building blocks to managing the pharmaceutical, medical device, biological, and controlled substance areas of our business.
Standard Operating Procedure executions are automated through our Kalliste Sample Management Software in order to ensure accuracy and consistency of data. Automation and control of procedures answers questions such as: Is the correct Chamber/freezer being used? Is the Chamber/Freezer calibrated? Is the sample technician trained and authorized to process samples?
Training is vital to LegalSafe’s daily operations to provide compliant service to our clients. The assertive hands-on training program ensures that personnel are in compliance with regulations and up to date with the latest technology in order to provide efficient results to our clients.
Environmental Chambers & Rooms
LegalSafe uses the most accurate and highest quality chambers and rooms available to the market with temperature and humidity controls well within the FDA mandated requirements.
The chambers that LegalSafe uses have been trusted by leading pharmaceutical companies for nearly 40 years and designed specifically to adhere to FDA mandated guidelines. These chambers have been mapped specifically for Pharmaceutical and Biological Sample Storage per the LegalSafe SOP’s. To maintain compliance of the equipment, the chambers are mapped annually using a Kaye Validator 2000 and are also monitored by the NIST traceable Elpro Libero Monitoring System. These chambers have been designed specifically for pharmaceutical stability testing and specimen storage and are trusted by many global leading pharmaceutical and biotech organizations.
For FDA mandated shelf life studies our chambers adhere to ICH Stability testing Guidelines including intermediate testing and accelerated testing per ICH Q1A (R2)
Chamber performance is also monitored in two different ways:
- Via the Elpro Environmental Monitoring System
- Via the traditional chart recorder process.
Full Alarm System per DEA Schedule I requirements including:
- Full Monitored Alarm System including Motion and Smoke Detectors
- Full CCTV at all entry and exit points to the building, storage suite and chamber doors. This is recorded via hard drive.
- Controlled Entry and Access cards
- Staff background and drug tested as per DEA and SOP requirement
Shipping & Cold Chain Logistics
To maintain chain of custody and transportation compliance, LegalSafe uses its own vehicles to collect and return samples to clients. Our vehicles allow the client to real-time track and document the vehicles journey from the client site to LegalSafe. Custom alerts can also be set up to monitor any extended stops or exceptions along the route. The real advantage of our service is if there is a change of plan or you have questions about your shipment that cannot be answered online a simple call can be made to LegalSafe and we can speak directly to our employee instead of dealing with a logistics company dealing with millions of packages.
LegalSafe uses state of the art shipping supplies in order to protect our clients’ products through its lifecycle from the point of pick up to the delivery of the samples for testing.
For international transit of products, LegalSafe is IATA compliant and its vehicles are USDOT registered for domestic transit.
Sample Management System 21CFR Part 11 Compliant
LegalSafe works with the well proven Kalliste Systems as its framework software and this provides complete and total regulatory compliance.
The Kalliste System fully meets the security requirements specified in 21 CFR Part 11 (the FDA’s regulatory document regarding electronic records and signatures). Part 11 requirements are met using password controlled access, electronic signatures and audit trails. Password controlled access through Active Directory based authentication allows centralized management of user accounts. Electronic signatures confirm the identity of the analyst. System generated Audit Trails provide both a record history and an activity history.
Control and Expedite the Approval Process through flexible management of business processes. Business process management (BPM) provides specific workflows for specific projects and environments (R&D, GMP, etc.). Signature control through workflows allows data availability to be controlled based upon current company or client approval practices. Workflows also provide automatic notifications (emails, SMS) and system generated “To Do” lists. Taken together, these features ensure that the status of any task can be viewed at any time. Eliminating the shuffle of paper and facilitating communication helps to further expedite the approval process.
Environmental Monitoring 21 CFR Part 11 Compliant
LegalSafe uses the market leading and well established Elpro Libero Monitoring system for all biobank and pharmaceutical stability testing needs.
- System is FDA 21CFR Part 11 Compliant, JCAHO, GLP,GMP,GAMP
- Redundant System with data storage and alarm features even if the network connection fails
- Data safely stored during power outage
LegalSafe goes beyond the requirements of the following regulatory agencies and industry standards:
- FDA Registered and Audited facility for HCT/Ps
- ICH stability testing per Q1A
- cGMP (Current Good Manufacturing Practices)
- GLP (Good Laboratory Practices)
- GSP (Good Storage Practices)
- GTP (Good Tissue Practices)
- 21 CFR Parts 11, 58, 210, 211, 820, 1300
- 40 CFR Part 160
- ISO 9001:1994; ISO 9001:2008 Compliant
- ISO 17025 Compliant
- OSHA Compliant
- IATA Compliant Transportation