blog Creating SOPs for Continuous Monitoring Systems Paul Daniel Senior Regulatory Compliance Expert Share Published: Aug 2, 2019 Industrial Measurements Life Science Dear Vaisala, We are hoping to save time in creating a Standard Operating Procedure for our viewLinc monitoring system. Does Vaisala offer any reference materials for viewLinc SOP? We understand that an SOP is basically created and managed by each customer, but a sample would help as a starting place… Thanks for your help! Paul Daniel writes: Thank you for reaching out to us! The regulatory requirement is that a GxP-regulated application have a written procedure describing the monitoring process and written storage specifications for products.? It is a simple requirement that can be interpreted into many different methods of documentation, including SOPs. When using a computerized monitoring system (such as viewLinc) to monitor the temperature of a physical space (like a refrigerator or warehouse), the procedures created will be quite similar because they are based, in part, on the software. The variations occur in how a particular company chooses to create storage specifications and written procedures.? From company to company, there are different approaches to documentation, policies, policy implementation, specifications, and procedures. It is my hope that companies that like detailed SOPs (see variation #5 below) can reference the Tours that are in viewLinc. viewLinc Tours give onscreen instructions for common tasks in viewLinc to ensure users can complete tasks the first time they use the software. Tours help users complete tasks the same way each time they use the software – especially useful if you only perform certain tasks occasionally. The tours can definitely make SOPs much easier to write, follow, and maintain. Here are some variations in how SOPs can be created for viewLinc: 1.?Storage specifications may simply be the conditions on the label and not a specific document. 2.?Storage specifications may be grouped into categories, such as refrigerated (2 to 8°C), cool (8 to 15°C), room temperature (15 to 25°C), etc. 3.?Specific chambers or rooms may be assigned such a temperature category. 4.?There may be several generic SOPs that apply to all computer systems, including password management, audit trail review, employee on-boarding, system backup. 5.?There may be a detailed SOP for how to use the monitoring system. Like so: do this, click here, write this in that field, click save, etc. 6.?There may also be a detailed SOP based on specific monitoring goals (keep medicine A between 2-8°C and file a deviation if the temperature is out of specification for over 30 minutes). This may say very little about how to use the actual software, and rely on the user manual instead for instructions. The range of possibilities is so wide that it has not proven to be useful for Vaisala to create a template SOP for our customers.? Most customers have to follow their own internal policies on creating written procedures, so many do not often have the freedom to follow our recommendations or a template. Here are my recommendations for documentation to create in-house in support of viewLinc software: ??A specification document o?This lists the allowable temperature range for each area or unit type, including allowable excursions (maximum temperatures and times) and expected responses to these excursions.? This should also list the responsible persons, by title rather than by name to avoid revision every time there is a personal change. ??A configuration specification document o?This describes the settings for viewLinc, including establishing a limited number of security profiles (called: “Groups” in the software) and a limited number of alarm threshold and notification templates, as well as a drawing, and a table of the physical location of each device, and to what “Location” in the software it links to.? This will help create and maintain order and naming conventions within the system. ??A monitoring SOP o?This describes the high-level actions taken within the monitoring system with very simple sentences. For example: Acknowledge the Alarm, Create a User, etc.? Such a document is easier to maintain and follow if it is simple. When a more detailed process is needed, it can reference viewLinc’s User Manual or the Tours. Related Webinar In our webinar "Audit-proof your Monitoring System" I have a chapter outlining SOPs. You can access the slides (PDF) here and watch the recording. Further reading on GxP compliance for continuous monitoring systems. ? SOP Examples: Just for reference, here are a few examples. But, it’s the responsibility of every facility to create their documentation around the system to ensure their compliance and operational goals are met. Alarm Acknowledgement ?? This section of the SOP specifically details the types and steps to respond and acknowledge CMS alarms. All users can receive alarms, but only specific users with the proper access level can acknowledge alarms. This facility’s alarm threshold set points are set per Table 1 of this SOP. Set point changes must be approved per the Process Change Control SOP. Step?Action 1.?Facility and/or calibration departments are responsible for receiving/acknowledging alarms via cell phone (text) and/or emails. 2.?In viewLinc select the Alarms / Active Alarms Tab. Then select the active alarm to acknowledge.? Reference Environmental Monitoring Location Map, if needed, to verify alarm location. 3.?Follow Figure 1. Alarm Investigation Flow Chart.? Based on flow chart continue with acknowledging alarm. Facilities and/or calibration technicians must notify Facilities Engineering and Supervisor once an out-of-limit (OOL) condition is confirmed. 4.?For communication alarms, a system check is required once connectivity to the server has been re-established. A channel history report shall be reviewed by Facilities Engineering to confirm no data loss and to confirm all sensor locations are reporting temperature, humidity, and differential pressure readings. 5.?For configuration alarms, a system check is required to ensure connectivity to the server. A channel history report shall be reviewed by Facilities Engineering to confirm no data loss and to confirm all sensor locations are reporting temperature, humidity, and DP readings. System configuration shall be reviewed against CMS Configuration Spreadsheet attachment of site validation report. ? Email Settings Management a)?Email settings rarely require changes after the system is initially configured.? However, if network changes are made that affect emails, it may be necessary to update the email settings. b)?The Email Settings window is access through Options > System Configuration > Email Settings. c)?The Email Settings use standard mail protocol settings, such as SMTP, and POP3 (if required).? d)?Enter any changes that are necessary.? After changes are made, the settings may be immediately tested by selecting the “Test Email” option from the Email Settings: Options drop down menu.? e)?Save all changes before exiting the Email Settings window. f)?NOTE: The appropriate facility change control process may be applicable to any changes to email settings. ? Finally, here is a blog from The FDA Group?that gives a good outline on writing?SOPs. Vaisala Hardware – Testing Beyond Promise At Vaisala, we put our products through a series of environmental and mechanical tests to learn the points of failure or weakness. We test beyond what we promise, in temperature, vibration, drop heights, and more to ensure the hardware is robust, reliable and accurate. In this longer version of the video, Senior Engineer Fiki Jusuf describes the testing process. https://dreambroker.com/channel/xv75lf0l/ijjz0mmo ?