LegalSafe has facilities in Boston, MA and central New Jersey. The dedicated storage facilities are designed with the following attributes:
- Modern Dedicated Storage Facility
- Controlled access to building
- Further controlled access to Sample Storage area
- Low Crime Location
- Geologically stable and climatically low risk location
- Close to major interstates and 4 major airline hubs which allows for same day delivery in many cases.
Temperature and Humidity Control
LegalSafe uses the highest quality equipment across all temperature and humidity conditions
- State of the art most accurate rooms available in the industry with typical accuracy of +/- 1°C and +/- 2% RH uniformity
- Stainless Steel internal construction
- American manufactured unit with spare parts on site readily available in USA
- High Capacity freezers
- Backup Liquid Nitrogen connected in case of mechanical failure
- Market leading Cryogenic freezers which are centrally monitored through our Kalliste Sample Monitoring System
- Vapor Phase Liquid Nitrogen to reduce risk of contamination
- Small Access port on freezer to reduce temperature droppage when samples are placed in or taken out of chambers.
- Autofill LN2 System with low level alarm
- Backup LN2 Freezer and LN2 supply
cGMP (Current Good Manufacturing Practices) Compliance
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
64 Standard Operating Procedures (SOP’s)
LegalSafe maintains 64 Standard Operating Procedures (SOP’s) which cover all aspects of the 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?
- Although power outages are very rare, LegalSafe has a succinct plan to cover any eventuality.
- Backup Detroit Diesel 150KW generator with automatic switch (Per LegalSafe SOP’s generator is cycled every two weeks as well as a very strict maintenance Schedule
- Redundant chamber for each temperature condition
- Freezers are hard wired to LN2 backup in case of mechanical failure
LegalSafe offers a full Alarm System per DEA Schedule I:
- Fully monitored Alarm System including Motion Detectors in all office spaces and chamber locations.
- Smoke Detectors throughout facility.
- Full CCTV at all entry and exit points of the building as well as entry and exit points of the Biopharma storage unit. This CCTV is recorded and backed up offsite.
- Controlled Access with data cards. This information is logged and controlled.
- Staff background and drug tested as per SOP requirements.
- Sprinkler System throughout facility
- Monitored Smoke Alarm System