Services - Tera Coldchain

Validation/qualification

admin_tc — Tue, 27 Sep 2022 23:19:55 +0000

Validation of computerized systems regulated by Application 11 GxP EU Manual for pharmaceutical industry. The concept of a computerized system includes: computer hardware, software, peripheral devices, networking system, documentation, and staff, which interact with hardware and software. Besides of documented proof of the system compliance by certain requirements, validation covers whole life cycle of a computerized system – starting with design and ending with decommissioning.

Validation Documents include:

User Requirements Specification (URS)
Project
Functional Specification (FS)
Technical Specification (TS)
Configuration Specification (CS)
SOP manuals for Maintenance and Operating

Availability of the actual project, URS & FS are components for successful pass of the first stage of validation – project qualification (DQ). On a stage of montage qualification (IQ) it’s required to check equipment package, proper installation, package and actuality obtained documents, correspond of using device base in TS, correspond view and correctness device name. On a stage of functioning qualification (ОQ) it’s required to check trained staff, SOP documents, correctness system function fulfill and related equipment. In this case, all conditions of the test must be approached to conditions of real system operation. On a stage of working qualification (РQ) it’s required to check correctness system operation by determined requirements.

Computerized systems of TERA company fully correspond by validated requirements. TERA company also provides with validation services for its customers, which fulfilled by TERA’s staff cooperating with leading expert in validation.

The post Validation/qualification first appeared on Tera Coldchain.

Technical documentation

admin_tc — Tue, 27 Sep 2022 23:16:08 +0000

Automatic temperature and humidity monitoring system ATHMS supplied with full of set of required technical documentation. TERA company also provides all of its equipment with required set of metrological documentation (verification and calibration certificates), both by system installation and by its operating furthermore, when interverificating period ends up.

What’s included:

User manual on software
Administrator manual on software
Manual on operation for G2-CP Data Logger
Manual on transducers operation
Technical certificate on transducers, data logger and electrical panel
Schematics and list of electrical panel components
Verification or calibration certificates
Cabling and transducer arrangement diagrams

PJSC TERA also provides with serves for creating full set of documents of project stage named Working Documentation.

The post Technical documentation first appeared on Tera Coldchain.

Montage, adjustment and instruction

admin_tc — Tue, 27 Sep 2022 23:10:41 +0000

TERA company has in its disposal own engineering staff, that fulfills montage and launching tasks for customer’s properties. Its staff has obtained corresponding engineering qualification, trained safety rules by fulfill launching procedure and required access occupational safety and health.

Monitoring system deployment divided on several stages: cabling, montage and equipment connection, installation and setting software, staff tutorial, validation. On customer’s properties may be up to 5 staff depending on deployment stage, from montage to validation.

After system commissioning, it’s technically serviced by guarantee and post-guarantee, concluding corresponding agreement. TERA company has its technical support service, that’s using the monitoring system. It has possibility to connect to customer’s monitoring system via Internet, and to solve the issue rapidly.

The post Montage, adjustment and instruction first appeared on Tera Coldchain.