Posts in Category "Electronic Submissions"

Design a Document review & approval workflow using eSubmissions – Part 2

In the first article, we discussed how to create a review commenting and approval template. In this article, we will talk about “how to initiate a Review Commenting and Approval process

Initiating a Review Commenting and Approval process
To initiate a RCA process, you can log in to eSubmissions’ review portal using your credentials. Review Portal is a one step portal for authoring, initiating and tracking review, commenting and approval (referred as RCA hereafter in this document) workflow.

Once you log in to review portal, navigate to “Initiate Review” tab. You would see a list of all the active templates.

To initiate a RCA process, please select desired review template.

Selecting a template
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Once you select a template, initiate wizard would start.

Defining the Review Title and Description

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Provide a title for the Review Title and description and click next. Please note that regulation value can not be changed here, values entered at RCA template creation level can not be edited or modified while initiating the RCA process.

Stages and Timelines
Next screen would display the list of stages and speculated timelines for each participant in every stage. In case of serial review/approval stage, total duration of stage would be equally divided in all the participant. Please note that this is not the actual time line, only speculated time based on the total duration of the stage.

In a serial review/approval, if a participant consumes most of the time allotted to that stage, then moderator/initiator can use review dashboard and increase the duration of the stage on need basis.

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Adding Participants
You can add more reviewers/approvers/moderators by clicking “Add Participant” button on the above screen.
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Please note that you can not remove/modify the participants added template creation level.

Supporting Documents
You can add supporting documents at the time of initiation, to read more about supporting documents. Please read part1 of this series.

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After adding supporting document, click next to go to next step.

Adding Content for Review Commenting and Approval
The final step is to add main content that is to be reviewed and/or approved. You can browse and add multiple documents on this screen, those documents will be converted to pdf. And, combined into a single document. That final master document will be passed to RCA workflow.

Please note that for PDF conversion to work, necessary LiveCycle components should be installed on server.
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Once you click finish button, RCA workflow would be triggered. Required participants in RCA process would receive email notifications from time to time about the progress of the process.
Upon initiation, stages would execute in sequence. First the reviewer/approvers in the first stage would be assigned the tasks. To see the task, user would have to login to LiveCycle Workspace. To see the progress of RCA process, you can use eSubmissions Dashboard. Dashboard applications is just another tab within review portal.

In coming articles, we would try some more advanced options while creating RCA template.

Design a Document review & approval workflow using eSubmissions- Part 1

Electronic Submissions Solution Accelerator enables the rapid delivery of managed and auditable review, commenting and approval solutions.

In this article (first in its series), I will explain how to design a multi-user and multi-stage review and approval workflow.

First Step
First Step in defining a review and approval workflow is to define a review template.

Review Template
A review template can be considered as a logical grouping of the review attributes and is identified with a user friendly name, for example, Floor Plan Review Template.

The review administrator will define multiple such review templates. These templates can be modified or deleted if needed.

Defining a Review Template
To create a review template, you can log in to eSubmissions’ review portal using your credentials. Review Portal is a one step portal for authoring, initiating and tracking review, commenting and approval (referred as RCA hereafter in this document) workflow.

Once you log in to review portal, navigate to Templates tab. It will show you all the existing templates. To define a new template, click on new. Clicking on new would start the following wizard that would guide you through creating a review template.

Template Definition

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Enter Template Name say “Demo Template” and description on the “Template Definition” screen and click next.

If you do not want this template to be used for initiating RCA processes. You can uncheck “Active” checkbox, this would keep the RCA template in kinda of draft state (upon saving). Or in other words, only active templates would be available while initiating a RCA process, So, to avoid your template appearing in the list of available templates under “Initiate Review” tab, you can uncheck the “Active” checkbox.

Leave other fields as it is, we will discuss these in later articles in the series.

Commenting
On the next screen in the wizard, define the comments visibility. For now, you can just click next and let the default value be taken. We will come back to this a little later.
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Stage Building
An Enterprise can define multiple stages of review for a kind of review. Each stage may involve one or many reviewers.

For example, a new business plan may require following reviews:

  1. Technical review – to assess the technical feasibility of the business plan
  2. Business review – to assess the business viability of the business plan
  3. Legal review – to assess if the business plan is legally sound in the jurisdiction where the business is supposed to take place

Each stage of review/approval is carried out in sequence. Each stage will have at-least one moderator. Within each stage, there can be one or many reviewers. Each stage may define the review/approval to be sequential or parallel.

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Select Stage type as “Parallel Review” from the type drop down.
Provide a name to the stage “Frist Review Stage”.
Click on “create” button. This will take you to next screen to define other stage attributes like duration, pre/post process, reminder configuration etc.

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Provide duration for the review, enter number of days. Reminder can be configured additionally if you want. Click on next to go to next step

You can leave pre-review process and post-review process as it is, we will discuss these more advanced options in coming articles in this series.

Next Step is to Add Reviewers

On this screen, you can search for users configured in your LiveCycle Server and add those users as reviewers or moderators. Please note that a stage require at least one moderator and one reviewer to initiate a review. So, you can choose not to select any moderator or reviewer at template creation level, but then you must select at least one moderator and one reviewer at the RCA initiation time. We will again discuss this, when we will talk about initiating a RCA process.

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while adding a reviewer, you can select whether the review is mandatory or optional. By default every reviewer is mandatory, you can choose to make some reviewer optional by selecting optional from the drop down.

A review stage is marked as complete only when all the mandatory reviewers have completed their review tasks. If a stage duration is expired, the stage is marked as expired and all tasks assigned to reviewers are pulled back from their queues. if any stage in a RCA process expires, the complete RCA process is marked as expired.

So, this means RCA process would proceed to next stage, when all the mandatory reviewers have completed their review task. If instead, you want RCA process to wait till the full duration of stage, irrespective of whether all the reviewers have completed, you can select “continue review for specified duration regardless of completion” on previous stage definition screen.

After adding the reviewers on this screen, you can click “Add New Stage” button to add another stage.

On the screen add, stage name as “Second Stage-Approval” and select type as “Parallel Approval” from the drop down. Adding an approval stage is almost similar to adding review stage, only some of the terminology changes. Click on create button to take you to the next screen.

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In case of approval , you can also define what type of signature is required. We will discuss use of signature in approval in coming articles, for now, we can leave it as “None” and proceed to next screen.

On the next screen you can add and select approvers and moderators for this stage. Please note that a stage require at least one moderator and one approver to initiate a RCA process. So, you can choose not to select any moderator or approver at template creation level, but then you must select at least one moderator and one approver at the RCA initiation time. We will again discuss this, when we will talk about initiating a RCA process. After adding approvers and moderators, you can click next to go to next step in defining template.

Supporting Documents
Supporting documents serves the purpose of reference documents for the main document in the RCA process. Supporting document can be a link also, to support cases, where may be an already existing link on intranet or internet is to be used as supporting document. Alternatively, supporting document can be uploaded from your local system as well.

Supporting documents can be supplied at the template creation level or at the RCA initiation level. Supporting documents, supplied at template creation level, are available to all the RCA processes which are initiated from that template. So, at template creation level, you might want to supply those supporting documents that applies to all RCA processes initiated from that template e.g. any compliance code specification document, any other protocol specification document etc.

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After adding supporting documents, click next to reach next step. This screen can be skipped as of now, we will discuss this in coming articles. To skip the screen click next and we reach the final screen.

Audit Levels
You can select any of the existing Audit Levels and click finish to save the template. You can also define your custom audit levels, but that is outside the scope of this article series.
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You can verify that newly created template appears on first screen under “Templates” tab in review portal. You can modify/view/delete the template from there.

Now, you have created a RCA template. The next step is to initiate a RCA process using this template. How to initiate a RCA Process will be covered in part 2 of this article.

Review Commenting and Approval Building Block

This series of articles provides you with tips, tricks and all you wanted to know about the Review Commenting and Approval Building Block.

Following new entries have been added:
Create custom process to initiate a RCA process

Electronic Submissions Solution Accelerator

Read on to find out more on Electronic Submissions Solution Accelerator.

eSubmissions Solution Accelerator is built on the Review Commenting and Approval and On Demand Assembly building blocks.

To learn how to design and initiate a Review Commenting and Approval workflow using eSubmissions, you can read the following article series:
Part-1
Part -2

Announcing the release of the eSubmissions Solution Accelerator v1.0

The extended eSubmissions solution accelerator team is pleased to announce the immediate availability of eSubmissions 1.0. Building on the foundation of LiveCycle ES, the eSubmissions Solution Accelerator enables the rapid delivery of managed and auditable review, commenting and approval solutions for life sciences. The eSubmissions Solution Accelerator will help Adobe’s life sciences customers bring new drugs and devices to market faster and with better oversight, and will help them reduce the burdens of their regulatory compliance efforts. Beyond life sciences, the eSubmissions Solution Accelerator can help Adobe systems integrators, partners, professional services, and customers rapidly deliver managed review, commenting, and approval solutions built on LiveCycle ES, for applications such as legal/contract review, manufacturing design reviews, and any other procedure-based review and approval process.

Along with life sciences-specific samples and documentation, the eSubmissions Solution Accelerator is built on the new Review, Commenting, and Approval and the updated On-Demand Assembly building-blocks. The Review, Commenting, and Approval building block combines the PDF collaboration tools of Acrobat and Reader with the structure and process management of LiveCycle in an auditable environment. The eSubmissions Solution Accelerator also includes the latest version of the On-Demand Assembly building block. The On-Demand Assembly building block enables forms and documents to be assembled into PDF Portfolios and documents based on business rules. These new technology building blocks add value to LiveCycle ES by enabling the rapid development of enterprise applications targeting the needs of Adobe’s enterprise customers.

eSubmissions Solution Accelerator:

http://www.adobe.com/devnet/livecycle/solutions/ls_esubmissions.html

More information about the Solution Accelerator program and other Solution Accelerators:
http://www.adobe.com/devnet/livecycle/solution_accelerators.html

Your feedback, suggestions, and questions are greatly appreciated, and can be made via the user forums.

With the formal announcement of eSubmissions v1.0, we’d like to add a note of thanks and acknowledgement to the many people who downloaded the pre-release version and provided feedback.

Ed Chase
Solutions Architect, Life Sciences & Manufacturing

Ashish Agrawal
Group Product Manager