CLOSING COMPLIANCE GAPS IN YOUR IT LANDSCAPE

ARXUM BLOCS

Safeguarding data integrity in between LIMS, LES, SDMS and ERP

Today, due to a high volume and speed of daily operations, you can’t be sure that every single process deviation in your laboratory is detected when data is exchanged between LIMS, LES or ERP systems. And the probability for compliance issues is even higher when it comes to manual processing of data on file systems and servers. But it does not have to be like this.

Imagine your QA staff was averted of any compliance risk or process deviation and the data integrity is guarded 24/7 in real time.
Imagine your sensitive raw data was protected against ransomware and could be recovered at any time based on an ultra safe, easy to manage and efficient blockchain technology seamlessly connectable with your existing IT structure.

Do it with BLOCS – the perfect lab system add-on

Risk Elimination

BLOCS supports the quality management with real-time alerts on any process deviation as it occurs allows detecting risks and preventing errors long before they have a customer impact. A management reporting and alert system provides holistic information on compliance of each lab run, independent of lab system vendor. BLOCS enables you to prove to your customer that in no circumstance a delivery of irregular results is possible!

End-to-end Digitisation

BLOCS closes the gap between a lab system audit trail and data fed into a LIMS, SMDS or ERP system, linking all information together with a sole focus on safeguarding compliance. But why stop at half-way? Continue integrating your digital supply chain with customers by directly providing digital results faster and more secure! With BLOCS customers could access lab results, including a digital certificate of result compliance, cutting down delivery times to 50% or less compared to a manual process.

Cost Efficiency and Productivity Gains

BLOCS provides everything in a nutshell. There is no additional hardware or service integration required, no trailing hidden costs will occur outside this software-as-a-service. Tedious paper-based processes and manual signatures can be abandoned and operators are liberated from non-productive documentation tasks. Get more work done in less time with the same workforce.
IT Admins spend less resources on data integrity monitoring or backup procedures. BLOCS is vendor neutral, so there is no lock-in effect for specific hardware vendors or LIMS providers, all your existing IT landscape remains intact.

You want to learn more about ARXUM^® BLOCS?

Then register for our free webmeeting.

You want to learn more about ARXUM^® BLOCS?

Then register for our free webmeeting.

Automated Surveillance of Lab Equipment

Minimally invasive installation with no need for operator training

Quality managers and shopfloor staff profit from real time alerts (pop-up or email) when a compliance risk is detected during analysis execution. Mangers can immediately remedy the process deviation with electronic signatures.
By providing monitoring agents for various different laboratory systems, any process can be integrated with lowest effort. BLOCS is extensible to monitor Excel & Word files of SOPs, process definitions or any GLP relevant files.

State of the Art Blockchain Storage

A future-proof solution based on cryptographic security

BLOCS uses state-of-the-art blockchain technology and distributed storage (IPFS) to safeguard raw data. Blockchain provides a common standard interface with highest security settings for immutable storage with cryptographic encryption against data manipulation. Data is safeguarded on an external, decentralised infrastructure, protecting against attacks and ransomware for restauration at any time in an instant.

Minimum Invasive Integration

No intrusion into existing work procedures - just value-added transparency

Lab operators are not bothered in their daily work and do not require any additional training for BLOCS. Rather, they gain confidence that if no notification pops up, they just did an impeccable job and do not need to worry about any compliance risks. QA managers get the holistic overview of work performance and compliance status via an easy-to-use interface. This is made possible by pre-configured monitoring agents for established lab systems.

Why BLOCS outperforms traditional lab systems

Other systems (LIMS, LES, SDMS)

Classic infrastructure with internal database
Hosting with high security efforts
Limited support of external systems
Compliance gaps and data integrity breaches in data processing are possible
No secure data transfer to external customer

ARXUM BLOCS

Blockchain backend
State-of-the-art data security with integrated IPFS storage and raw data recovery
Vendor neutral in a diversified IT landscape
Compliance rule & data integrity enforcement
Future customer involvement

You want to learn more about ARXUM^® BLOCS?

Then register for our free webmeeting.

You want to learn more about ARXUM^® BLOCS?

Then register for our free webmeeting.

All features making BLOCS the first choice for GMP compliance:

FDA Part 11 compliant
GAMP5 pre-validated
Long-term raw data archiving
Data life cycle management
Result reproducibility
Electronic Signatures

ALCOA+ workflow
Internal API available
Agents for various lab systems
Vendor-neutral
Cloud storage
On-premise capability

File observation
Realtime alerts
Email integration
Active Directory integration
Ransomware protection

Compliance Rule Management
Audit Trail Logging on-chain
EOSIO Blockchain
IPFS Cluster
Cryptographic security standards

BLOCS Ecosystem

Technical Advantages based on BLOCS

Minimal invasive integration in existing IT network and monitoring of various vendors in a single web-based portal
Excellent support of different analysis systems and interfaces
Integrated cryptographic encryption and long-term storage with real-time raw data archiving by design
Super-scalable infrastructure via distributed access and replication for high data safety

Business advantages

Early detection of risks and compliance compromise reduces error rate and increases process quality
Detection of non-compliant analyses in real time before delivery to the customer
No unnoticed deviation from prescribed compliance guidelines possible: Risks of non-compliance of FDA 21 CFR Part. 11 (open and closed systems)
Enables paperless, digital signature of lab staff and management across diverse lab systems