Facility Explorer for Validated Environments

Transcription

1 Facility Explorer for Validated Environments User s Guide 1 Facility Explorer for Validated Environments Introduction Facility Explorer for Validated Environments is an information-based software application that enables you to measure and analyze facility performance and to help facilitate Food and Drug Administration (FDA) Title 21, Part 11 Certification. This document provides an introduction to Facility Explorer for Validated Environments and its features, and describes how to: generate reports retrieve Exception report details attach exception details to a report download a report a report November 01, 2001 Johnson Controls, Inc. Code No. LIT

2 2 Facility Explorer for Validated Environments User s Guide Key Concepts Facility Explorer Features Facility Explorer features include reporting capabilities that include capturing validated environment data during the drug manufacturing process and mean kinetic temperature reports. Solution Packs Facility Explorer includes a base package and the Validated Environments package. Base Package The base package includes: Facility Explorer Web - time series data profiling - simple generic report - spreadsheet and raw data export Facility Explorer Historian (FX-Historian) time series data store N1-Collector for data acquisition and communication Validated Environments Package The Validated Environments package includes: Validated Environment data capture during the drug manufacturing process regulation compliant reporting including trend graphs and reports, alarm reports, transaction audit reports, and batch process record reports reports packaged and electronically signed and secured as required by regulation The same data and tools can be used for performance analysis of the critical environment by adding other solution packs.

3 Facility Explorer for Validated Environments User s Guide 3 View A view provides a way of looking at your organization s facilities and points. It is presented as a hierarchical tree structure (Figure 1). An organization can have multiple views, and each view may share facilities and points. Figure 1: Sample View Folder Data Group A folder organizes points into logical groups such as state, city, or building. A data group is a node that only has points associated with it. The points must be specific to that data group type.

4 4 Facility Explorer for Validated Environments User s Guide Point A point is a field sensor such as temperature or humidity. Table 1 describes the point icons. Table 1: Organization s Tree Icon Descriptions Icon Description Humidity point Indoor air temperature point Air flow point Binary point Pressure point Point that has not been assigned a point type Default image for point types that do not have a custom image Mean Kinetic Temperature Exception Details Mean Kinetic Temperature (MKT) is a calculation used by the FDA to determine if a drug was exposed to an excessive temperature and therefore might have lost some of its effectiveness. Regulations specify that drug manufacturing, storage, and transport areas cannot exceed a specific MKT value for a certain amount of time. According to FDA regulations, a minimum number of samples must be used to calculate the MKT. You can view details about an exception in graph or spreadsheet format. These details can also be attached to and downloaded or ed with a report. Facility Explorer Web User Interface Figure 2 shows the Facility Explorer Web interface. The left pane displays the currently selected view as a hierarchical tree structure. The right pane displays the report options form.

5 Facility Explorer for Validated Environments User s Guide 5 Figure 2: User Interface Table 2 describes the form s fields. Table 2: Report Options Forms Field Descriptions Field Reference Date Start Date End Date Reporting Period Reporting Interval Drawing Interval Available Reports Graph Type Select All Deselect All Submit Report Request Description The date used as a reference when selecting a reporting period such as previous day, previous month, etc. The starting date for the report period. This field is enabled when Date/Time Range is selected as the reporting period. The ending date for the reporting period. This field is enabled when Date/Time Range is selected as the reporting period. The time frame for which the data is reported. Specifies how the data is grouped, such as hourly or monthly, for a reporting period. Specifies the frequency in which points are displayed on the graph. A list of reports you can generate for the point type you selected. The type of graph in which to display the data. You can select any combination of graph types. Selects all of the reports in the Available Reports list. Deselects all reports in the Available Reports list. Generates the reports.

6 6 Facility Explorer for Validated Environments User s Guide Report Buttons Table 3 describes the buttons available at the top of the report options form. Table 3: Facility Explorer Report Options Buttons Button Name Description Show Report Returns you to the report options frame. Options Show Graph Show Report Show Downloadable Files Show Current Report Form Displays the graphs. Each time you click this button, the system cycles through each of the graph types you selected. Displays the tabular or spreadsheet reports selected as part of the parameters. Displays a list of file types you can download. Displays the Current Report form.

7 Facility Explorer for Validated Environments User s Guide 7 Toolbar Table 4 describes the toolbar buttons available from the Facility Explorer Web workspace. Table 4: Facility Explorer Web Toolbar Buttons Button Name Description Select View Displays a list of views. Back One Time Period Forward One Time Period Record Observation Expand Tree Collapse Tree Toggle Selection Mode Open Facility Explorer Administrator Help Go Back to Main Toolbar (This button is available after you click the Select View button.) Changes the reporting period to the previous period based on the current reporting dates and the reporting period. If a report is currently displayed, it is regenerated for the new reporting period. If the report options are displayed, the dates change but the report must be manually resubmitted. Changes the reporting period to the next time period, which is based on the current reporting dates and the reporting period. If a report is currently displayed, it is regenerated for the new reporting period. If the report options are displayed, the dates change, but the report will have to be manually resubmitted. This feature is not yet available. Fully expands all of the tree levels. Collapses the tree view. Toggles between selecting just one or multiple points on the tree. Launches the Facility Explorer Administrator tool in a separate browser window. This button is only available to users with administrative rights. Displays Facility Explorer Web help in a separate browser window. Returns to the main toolbar. Facility Explorer Web Graphs There are four graph types in which you can display the data. Individual Line Displays the data as a series of points connected by a line. If you selected multiple points from the tree, multiple lines display each representing a point.

8 8 Facility Explorer for Validated Environments User s Guide Aggregated Line Combines the data from multiple points, displaying the results as one line. Stacked Bar Chart Displays the data as a stacked bar, with each point identified by its own color. Side-by-Side Bar Displays the data as a side-by-side bar. Like the stacked bar chart, each point is identified by its own color. Facility Explorer Web Generic Reports The reports available for you to generate are based on the point type you select. Some reports are only available for a specific point type, while other reports are available regardless of the point type. The report time is when the data was collected and is based on the time zone of the selected point. If multiple points are selected and they cross time zones, the report is generated for the most Eastern time zone. The report s generation date and time, which is when you generated the report, is also based on the point s time zone. For example, if someone in Milwaukee generates a report for a site on the West Coast, then all times on the report, including the generation time, reflect the West Coast time zone. After you generate a report, you can download it as an Excel spreadsheet or PDF file for further analysis or save it on your hard drive. You can reports you generate with Facility Explorer to one or more recipients. Your address appears in the Reply To field of the Current Report form and can only be modified via your user profile. You can generate the following reports for every point type: Gaps Average/Minimum/Maximum Summary Exception Data Graph

9 Facility Explorer for Validated Environments User s Guide 9 Gaps Report The Gaps report displays intervals of missing data and can be generated for any point type. In the sample report (Figure 3), the Cage A humidity was not recorded from August 1, 2000 through September 30, The total gap lasted 60 days, as displayed in the Gap in Day(s) HH:MM column. Figure 3: Gaps Report

10 10 Facility Explorer for Validated Environments User s Guide Average/Minimum/Maximum Report The Average/Minimum/Maximum report is also available for every point type and displays the minimum, maximum, and average usage for each of the dates in a selected date range. Figure 4 displays the average, minimum, and maximum temperature for January, Figure 4: Average-Min-Max Report

11 Facility Explorer for Validated Environments User s Guide 11 Summary Report The Summary report (Figure 5), which is available for every point type, displays a summary of the minimum and maximum value for the selected date range and the average of the daily average value for the date range. For example, Animal Cage A had an average temperature of degrees for the month of January, The minimum temperature was degrees. The Grand Average/Min/Max is the average of the two sites, the overall minimum usage and the overall maximum usage. Figure 5: Summary Report with Temperature Points When two or more different point types are selected, the Summary report does not display the Grand Average/Min/Max values (Figure 6).

12 12 Facility Explorer for Validated Environments User s Guide Figure 6: Summary Report with Humidity and Temperature Points

13 Facility Explorer for Validated Environments User s Guide 13 Exception Report The Exception report is available for any point type and displays deviations from typical or expected data (Figure 7). Exception details can be viewed in graph and spreadsheet format. Figure 7: Exception Report

14 14 Facility Explorer for Validated Environments User s Guide Data Graph Report Data Graph report must be selected from the Available Reports list if you want to generate any type of graph. Refer to the Facility Explorer Web section for a description of the graph types. Figure 8 is an example of a temperature point line graph. Figure 8: Data Graph with Temperature Point

15 Facility Explorer for Validated Environments User s Guide 15 Facility Explorer for Validated Environments Reports You can generate the Mean Kinetic Temperature and Stability Summary reports when you select specific point types. Mean Kinetic Temperature Report The Mean Kinetic Temperature (MKT) report (Figure 9) is used on a single temperature point. It provides the calculated MKT and the number of data samples that were used to arrive at that calculation for the given time period and report interval. Figure 9: Mean Kinetic Temperature Report

16 16 Facility Explorer for Validated Environments User s Guide Stability Summary Report The Stability Summary report generates with a critical environment group of points, and the group can contain various point types (Figure 10). The report provides the average, high, and low reading for the given time period, and calculates the MKT for any temperature points in the group. Stability chambers store drug samples for long periods of time to test how long they last at certain temperatures. The data gathered from these tests determine the warnings put on drugs. Use the Stability Summary to report on the state of a stability chamber. Related Documents Figure 10: Stability Summary Report Table 5 lists the documents for products related to the Validated Environments Data Center. Table 5: Related Documents Document Facility Explorer Administrator Tool for Validated Environments User s Guide Installing Facility Explorer for Validated Environments Technical Bulletin Installing Microsoft SQL Server 2000 Technical Bulletin Converting AspenTech to SQL Server Technical Bulletin LIT Number -- LIT LIT LIT

17 Facility Explorer for Validated Environments User s Guide 17 Detailed Procedures Generating a Report To generate a report: 1. Click. The Select View drop-down list appears (Figure 11). Figure 11: Select View Drop-Down List 2. Click the down arrow to display a list of views (Figure 12). Note: Click to return to the main toolbar. Figure 12: List of Views 3. Click a view. The tree and its sites and groups appear (Figure 13). Figure 13: Tree Sample 4. Select the point type from the drop-down list (Figure 14). Note: [No Selection Filter] allows you to choose any combination of points on the tree.

18 18 Facility Explorer for Validated Environments User s Guide Figure 14: Points List 5. Select the points on the tree. Note: To enable multiple point selection, click to toggle to multi-selection mode. 6. Select the report parameters on the Report Options form (Figure 15). Refer to Table 2 for descriptions of these fields. Note: Figure 15: Report Options Form You can select multiple report types from the Available Reports list and multiple graph types from the Graph Type list.

19 Facility Explorer for Validated Environments User s Guide Click Submit Report Request The reports and graphs you selected as part of your parameters are generated. 8. Click to cycle through and view the selected graphs. 9. Click to view the selected reports. Note: If data exceeds the size of a cell, it displays as a series of pound signs (#). To view the actual data, expand the column width. Retrieving Exception Report Details To retrieve Exception report details: 1. Select the exception line. (Figure 16). Figure 16: Exception Report Line Item 2. Click the Retrieve Details button. The exception details appear in graph format in a separate browser window (Figure 17).

20 20 Facility Explorer for Validated Environments User s Guide Figure 17: Exception Details Graph 3. Click to display the data details as a spreadsheet (Figure 18).

21 Facility Explorer for Validated Environments User s Guide 21 Figure 18: Exception Details Report 4. Click Close Window to close the details window and return to the Exception report. Attaching Exception Details to a Report To attach exception details to a report: 1. Click on the exception line. 2. Click the Toggle Attach to Current Report button. An asterisk appears next to the line item (Figure 19).

22 22 Facility Explorer for Validated Environments User s Guide Figure 19: Exception Report with Attached Line Item 3. the report. (Refer to the ing a Report section.) Downloading a Report To download a report: 1. Generate a report. (Refer to the Generating a Report section.) 2. After your report is generated, click. The Facility Explorer Download screen displays (Figure 20).

23 Facility Explorer for Validated Environments User s Guide 23 Figure 20: Facility Explorer Download 3. From the list, click the file you want to download. A dialog box appears, and the report name defaults to FxReport.xls. (Figure 21). Note: The dialog box that appears varies depending on your browser and operating system. The example outlined here is for Internet Explorer 5.0 and Windows Figure 21: Save As Dialog 4. Change the file name and file location, if desired, and click the Save button. The report is saved. 5. Open the file in the appropriate application to view and work with the report.

24 24 Facility Explorer for Validated Environments User s Guide ing a Report To a report: 1. Click. The Current Report form appears (Figure 22). Figure 22: Current Report Form 2. Complete the form and click the Report as xls or Report as pdf button. The report is ed. A message saying the mail has been sent displays. Note: To clear the form, click the Reset Form button. Controls Group 507 E. Michigan Street P.O. Box 423 Milwaukee, WI Printed in U.S.A.