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CMC Process Timeline

This project timeline, created in OnePager for Smartsheet, tracks the chemistry, manufacturing, and controls (CMC) process for a portfolio of drugs.

Chemistry, Manufacturing, and Controls (CMC) timeline for a drug development program.


Download CMC Process Timeline as PDF      Download CMC Process Timeline as Image


OnePager Project Timeline

This project timeline features:

  • Swimlanes based on the delivery system so that injectables, controlled release, topicals, and orals are all grouped together in the same section.
  • Assignment of unique colors to each CMC phase: clinical batch, pilot batch, engineering batch, process validation batch, commercial batch.
  • All CMC activities for a given drug are lined up left-to-right in a single row, creating a timeline view of each project.
  • The time axis shows a long-range drug development plan that spans almost ten years.
  • The legend makes it easy to identify the same CMC activity across multiple projects.

This CMC Process Timeline was created in OnePager, timeline software for Smartsheet.

To learn more about how OnePager can help you keep track of your CMC requirements, get started today by downloading a free trial.

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Sample Files

This CMC Process Timeline was built using the following files, which you can download if you'd like to create something similar:

Smartsheet Samples

CMC Process Timeline (Smartsheet).xlsx (Excel for import into Smartsheet)

CMC Process Timeline (Smartsheet).tat (OnePager Template for Smartsheet)


Smartsheet Instructions

To build a CMC process timeline timeline like the example above, follow these instructions:

  1. Download the sample files above. The Excel file contains all of the different phases of the CMC process, and will be imported into your Smartsheet account, while the OnePager template will help define the layout of the timeline itself. Save both files to your desktop.

  2. To import the Excel file into Smartsheet, first log into your Smartsheet account.

  3. In Smartsheet, click on + Solution Center, and then on the Import screen, choose Microsoft Excel:

    Import from Excel into Smartsheet

  4. Point Smartsheet to the Excel file that you downloaded above and press Continue. On the Import Settings, review the name of your sheet, and then click Import::

    Finish importing from Excel into Smartsheet

  5. Now that the sample project has been imported into your Smartsheet account, go to your desktop, and click the OnePager button.

  6. On the OnePager start screen, click NEW to build a new timeline.

  7. Go to Select > BROWSE Smartsheet, log into your Smartsheet account, and then point OnePager to the example project.

  8. We need to change OnePager's default template to the one downloaded above. To do this, click on Change, and then BROWSE FILES to the OnePager template (*.tat) file. This OnePager template contains all of the data-driven formatting (styles, layout, etc.) that make the timeline look the way that it does.

  9. Once the custom OnePager template is selected, click on Create New Chart to build your timeline. It should look like the example at the top of this article.

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Microsoft Project Samples

CMC Process Timeline.mpp (Microsoft Project Plan)

CMC Process Timeline (Project).tat (OnePager Template for Project)


Microsoft Project Instructions

To build a CMC process timeline timeline like the example above, follow these instructions:

  1. Download the sample files above. The Microsoft Project file contains all of the different phases of the CMC process, while the OnePager template will help define the layout of the timeline itself. Save both files to your desktop.

  2. Open the Microsoft Project file

  3. Now that the sample project has been imported into Microsoft Project, go to your Add-Ins tab, and click the OnePager button.

  4. On the OnePager start screen, click NEW to build a new timeline.

  5. We need to change OnePager's default template to the one downloaded above. To do this, click on Change, and then BROWSE FILES to the OnePager template (*.tat) file. This OnePager template contains all of the data-driven formatting (styles, layout, etc.) that make the timeline look the way that it does.

  6. Once the custom OnePager template is selected, click on Create New Chart to build your timeline. It should look like the example at the top of this article.

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Free Trial

Planisware Enterprise Samples

CMC Process Timeline.xml (XML for import into Planisware Enterprise)

CMC Process Timeline (Planisware).tat (OnePager Template for Planisware Enterprise)


Planisware Enterprise Instructions

To build a CMC process timeline timeline like the example above, follow these instructions:

  1. Download the sample files above. The XML file contains all of the different phases of the CMC process, and will be imported into your Planisware account, while the OnePager template will help define the layout of the timeline itself. Save both files to your desktop.

  2. To import the XML file, log into your Planisware account, and create a new project.

  3. In Planisware, locate the menu on the right-hand side of the screen, and then click on the Import button:

    Import from Project XML into Planisware

  4. Click the Search for... button and browse to the XML file that you downloaded. For the Format, be sure to specify MSP (xml), and then click Import::

    Finish importing from Project XML into Planisware

  5. Now that the sample project has been imported into your Planisware account, go to your desktop, and click the OnePager button.

  6. On the OnePager start screen, click NEW to build a new timeline.

  7. Go to Select > BROWSE Planisware Enterprise, log into your Planisware account, and then point OnePager to the example project.

  8. We need to change OnePager's default template to the one downloaded above. To do this, click on Change, and then BROWSE FILES to the OnePager template (*.tat) file. This OnePager template contains all of the data-driven formatting (styles, layout, etc.) that make the timeline look the way that it does.

  9. Once the custom OnePager template is selected, click on Create New Chart to build your timeline. It should look similar to the example at the top of this article.

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Free Trial

Primavera P6 Samples

CMC Process Timeline.xer (Primavera P6 Schedule)

CMC Process Timeline (Primavera P6).tat (OnePager Template for Primavera P6)


Primavera P6 Instructions

To build a CMC process timeline timeline like the example above, follow these instructions:

  1. Download the sample files above. The Primavera P6 file contains all of the different phases of the CMC process, while the OnePager template will help define the layout of the timeline itself. Save both files to your desktop.

  2. Go to your desktop, and double-click the OnePager button.

  3. On the OnePager start screen, click NEW to build a new timeline.

  4. Go to Select > BROWSE Primavera P6 Files, and select the XER file that you downloaded in the first step.

  5. We need to change OnePager's default template to the one downloaded above. To do this, click on Change, and then BROWSE FILES to the OnePager template (*.tat) file. This OnePager template contains all of the data-driven formatting (styles, layout, etc.) that make the timeline look the way that it does.

  6. Once the custom OnePager template is selected, click on Create New Chart to build your timeline. It should look like the example at the top of this article.

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Free Trial

Excel Samples

CMC Process Timeline.xlsx (Excel Plan)

CMC Process Timeline (Excel).tat (OnePager Template for Excel)


Excel Instructions

To build a CMC Process Timeline like the example above, follow these instructions:

  1. Download the sample files listed above. The Excel files contains the CMC activities themselves, and the matching OnePager template file has most of the settings that drive the look and feel of the timeline based on the data from or Excel. Save both files to your desktop.

  2. Open the Excel plan.

  3. Once the project plan is open, go to Add-Ins and click the OnePager button.

  4. When the start screen appears, click NEW to build a new chart.

  5. Change OnePager's default template to the one downloaded above, making sure that you pick the template that matches the Excel plan that you downloaded. To do this, click on Change, and then BROWSE FILES to the OnePager template (*.tat) file. This OnePager template contains most of the data-driven formatting (colors, layout, etc.) that give this CMC Process Timeline its specific look.

  6. With the template loaded, click on Create New Chart. It should closely match the example at the top of this article.

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Free Trial