.png)
Vaisala viewLinc CMS: GxP Monitoring and 21 CFR Part 11
Environmental Monitoring You Can Act On
A freezer alarm arrives after working hours. A warehouse temperature rises during a busy delivery period. A cleanroom pressure reading moves outside its approved limit. Your team needs to establish what happened, respond promptly and retain the information needed for review.
The Vaisala viewLinc Continuous Monitoring System brings environmental measurements, alarms and historical records together. Seacom Malaysia can help review the instruments, connectivity and project requirements for a new installation or an expansion of an existing system.
What Is Vaisala viewLinc CMS?
viewLinc combines compatible sensors and data loggers with monitoring software. It provides current readings, historical trends, configurable alarms and reports across monitored rooms and equipment.
Depending on the connected instruments and interfaces, measurements can include temperature, relative humidity, differential pressure, carbon dioxide, dew point and other parameters.
- Measurements: Collect readings from compatible field devices.
- Visibility: Review conditions and device status centrally.
- Alarms: Notify responsible personnel according to configured rules.
- Records: Retrieve measurement history and relevant system events.
- Reporting: Prepare information for routine review and investigations.
Explore the Vaisala viewLinc system →
Where Can It Be Used?
A monitoring project should start with the material, product or process being protected. The following examples illustrate how requirements can differ.
- Pharmaceutical warehouses: Temperature and, where required, humidity records for stored materials and finished products.
- Refrigerators and freezers: Temperature monitoring with probes selected for the equipment's operating range.
- Cleanrooms: Temperature, humidity and differential pressure where these parameters form part of the monitoring plan.
- Laboratories and stability equipment: Records and alarms suited to the samples, studies and equipment involved.
- Industrial controlled environments: Monitoring selected conditions in production and storage areas.
Read our pharmaceutical and cleanroom measurement guide →
Choosing the Measurement Hardware
Vaisala VDL200: Wired Data Logging
The VDL200 uses Power over Ethernet and compatible probes to connect measurements to the monitoring system. It is an option for installations with suitable Ethernet infrastructure.
Review probe selection, network access, cable routes and backup power for the PoE equipment. Where additional input types are required, confirm the appropriate interface and software compatibility.
Vaisala RFL100 and AP10: Wireless Data Logging
The RFL100 uses Vaisala VaiNet wireless communication through an AP10 access point. It can suit projects where running a network cable to each monitoring location would be difficult.
Plan the installation around the selected probes, wireless coverage, building construction and maintenance access. Confirm performance at the intended locations during commissioning.
View Vaisala RFL100 and AP10 →
Vaisala CAB100: Centralised Instrument Integration
The CAB100 provides a cabinet arrangement for integrating transmitters with viewLinc. It can be considered for cleanroom pressure monitoring and installations using compatible analogue signals.
Specify the required channels, signal types, transmitter arrangement and installation details for the project.
GxP Monitoring: More Than a Temperature History
GxP covers good-practice frameworks such as Good Manufacturing Practice, Good Distribution Practice and Good Laboratory Practice. The relevant requirements depend on the facility's activities and the products it handles.
For a monitoring system, the practical concern is whether records remain trustworthy and usable throughout their required life. Personnel need clear responsibilities for reviewing data, responding to alarms and managing changes.
viewLinc provides technical functions that support these activities. The facility's quality system establishes how they are configured and used.
Understanding 21 CFR Part 11
21 CFR Part 11 concerns electronic records and electronic signatures. Its applicability depends on the records involved and the underlying FDA requirements. The quality team should establish whether the intended monitoring records fall within scope.
For an applicable electronic-record system, important controls include authorised access, secure time-stamped audit trails, record protection, accurate record copies and validation for intended use.
User Access and Responsibilities
Assign permissions according to job responsibilities. Consider who may administer the system, change alarm settings, acknowledge events and review records. Manage accounts when personnel join, change roles or leave.
Audit Trails and Record Review
viewLinc's event log provides audit-trail information. Establish which events require review, who performs that review and how findings are handled. Retaining an audit trail is only part of the process; relevant activity must also receive appropriate attention.
Electronic Signatures
A login or alarm acknowledgement should not automatically be treated as an electronic signature for approval. If signatures are required, verify the intended workflow against the applicable identity, signature meaning and record-linking requirements.
Using viewLinc does not automatically make a facility compliant. Compliance depends on the configured system, its validation and the procedures governing its use.
EU GMP Annex 11 and System Lifecycle
Where EU GMP Annex 11 applies, the assessment extends to the management of the computerised system throughout its lifecycle. Discuss risk assessment, supplier documentation, security, incident management, change control, periodic evaluation and business continuity with the quality and IT teams.
Define how the system will remain suitable after installation, including software changes, new monitoring points and changes to infrastructure.
IQ/OQ and Validation Planning
Vaisala offers qualification documentation and IQ/OQ services for its monitoring system. Confirm the required documentation, service scope and availability when preparing the project proposal.
- User requirements: Document intended use, monitoring points, alarms, records and acceptance criteria.
- Installation Qualification: Record the installed components and baseline configuration.
- Operational Qualification: Test specified functions against approved requirements.
- Application performance: Define additional site testing needed to demonstrate suitability under actual operating conditions.
- Ongoing maintenance: Manage calibration, training, system changes and periodic review.
A supplier's software validation documentation supports the work. Site-specific configuration and intended use still need to be addressed in the facility's validation approach.
Make the Alarm Useful to the Person Receiving It
An alarm should identify the affected location and reach someone who can act. For each area, agree on limits, delays, notification recipients, escalation and response responsibilities.
Also consider communication failures and equipment interruptions. Confirm the selected notification method, any additional services required and how the response will be recorded.
For example, a refrigerator excursion may require an equipment check, review of the duration and temperature trend, and a quality assessment of the affected contents. Acknowledging the alarm does not complete that investigation.
Plan for Interruptions and Recovery
Discuss what happens if a connection fails, a network switch loses power or the monitoring server becomes unavailable. Review local storage capacity and recovery behaviour for the selected devices.
Include backup and restoration arrangements in the project scope. Test the expected recovery process and identify any limitations before relying on it during an actual interruption.
Can viewLinc Work Alongside a BMS?
Yes. viewLinc can provide monitoring alongside a building-management system. Supported API or OPC UA options can also allow data exchange with other systems, subject to the selected software, interfaces and project configuration.
Agree which system controls equipment, which records support quality decisions and how each system's alarms will be handled.
Discuss Your viewLinc Project with Seacom
Whether you are monitoring a few storage units or planning a facility-wide installation, send us the rooms and equipment involved, required measurements, operating ranges and approximate number of monitoring points.
Include your network constraints, alarm requirements and any GxP or IQ/OQ expectations. Seacom Malaysia can help review the equipment and agree the scope of installation, commissioning, training and documentation support required for your project.
All comments