LegalSafe has taken its expertise and core skills in regulated pharmaceutical storage, which require strict FDA regulatory compliance, and applied them to the field of legal storage.
Over the last 5 years evidence storage has evolved dramatically. Many law firms now require their evidence to be stored at an independent third party. Prior to the emergence of this specific storage market, law firms had few options at their disposal. Either leave the evidence at its current location or store the product themselves, with all the risks associated. Neither option is an obvious competent solution.
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 our clients and their cases require. LegalSafe’s extensive experience with over 240 law firms across a myriad of different cases ensures compliance to all court-ordered protocols and strict client/patient confidentiality. In many instances, the team at LegalSafe has written protocols for specific projects to maintain compliance with any court ordered preservation protocol.
Quality of service is primarily built on the knowledge that our team is trained on mandated industry standards. 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, Sample Management, Cold Chain Logistics and Emergency Response.
These procedures are essential to maintaining compliance with all regulatory bodies and our clients’ most stringent requirements. Our daily business practices are incorporated into the Standard Operating Procedures (SOP’s) along with the regulatory requirements to guarantee proficient procedures. The SOP’s are the building blocks to managing the pharmaceutical, medical device and biological areas of our business.
IT Systems including Temperature Monitoring, Sample Inventory Systems, SOP storage and Training Records are all managed through 21 CFR Part 11 compliant systems which means that all systems have full audit trails and all systems are fully validated and tested. All documentation is securely backed up offsite.
LegalSafe personnel are trained to the highest standards including comprehensive HIPPA and cGMP training (Good Manufacturing Practices).
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 industry and FDA mandated requirements. The chambers that LegalSafe uses have been trusted by leading pharmaceutical companies for over 40 years. The chambers are tested and monitored to ensure that the set storage condition of the chamber is correct. This data is stored forever and can be supplied to our clients to show that their evidence has been stored at the desired condition throughout its time at LegalSafe. All chambers are tested with NIST (National Institute of Standards and technology) traceable thermometers.
Cold Chain/Shipping and Retrieval Kits
LegalSafe is able to control the whole process of sample management through the entire project lifecycle. LegalSafe contacts the evidence location, prepares the retrieval kits and generates all chain of custody documents for a full audit trail.
LegalSafe has IATA and DOT trained dangerous goods staff that are able to consult directly with the client on the project and recommend the best process for retrieval of evidence while ensuring regulatory compliance for dangerous goods in transit.
LegalSafe has its own vehicles for collection of samples where necessary as well as partnerships with the world’s leading logistics companies. LegalSafe is able to pick up and deliver samples to any location globally at any desired or requested temperature.
- FDA licensed and audited for HCT/Ps (Human Cells, Tissues and Cellular and Tissue Based Products CFP – compliance to 21 CFR Part 1271)
- 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
- ISO 9001:2008 Compliant
- ISO 17025 Compliant
- IATA Compliant for transportation (trained staff)
- DOT Compliant for transportation (trained staff)
- Sample Management Software – 21 CFR Part 11 compliant (full audit trail)
- Sample Monitoring software – 21 CFR Part 11 compliant (full audit trail)
- Employee Training Records Software – 21 CFR Part 11 compliant (full audit trail)
- SOP Management Software – 21 CFR Part 11 compliant (full audit trail)
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, Sample Management, Cold Chain Logistics and Emergency Response. 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.