Client is an Asia-based Healthcare organization involved in the discovery, research, development, validation and commercialization of unique, safe, natural compounds that have therapeutic properties in the human and animal health markets. Client is focused on strategy development to generate compounds for development into natural and safe therapeutic products for commercialization.
Client was processing Regulatory Affairs or RA request and RA initiation through manual approval forms for review and approval of various departments. They were maintaining request status and remarks of each department through excel spreadsheet. This manual process was inefficient, complex and long to achieve desired business objectives.
To overcome through this inefficiency, the client decided to develop a cloud-based RA Process Automation application using Salesforce platform. The application needed to be innovative to accommodate growth to evolve business.
The objectives of the RA Process Automation application is to automate current manual process and implementation of standardized business rules and terminology across departments. It included development of the following functionalities:
Creation of RA request and RA initiation forms
Capability to raise RA requests for product registration or notification and RA initiation for regulatory activities
Creation of request approval history to log steps of approval process
User category to manage RA request and RA initiation forms and approval process access
Visualforce
Apex
Eternus Solutions team reviewed the objectives and worked with the client to implement the RA Process Automation application, leveraging Visualforce and Approval Processes within Salesforce as the implementation technology stack.
User Category Management: User categories were developed using Profiles to provide defined access to the RA user and Business Development (BD) user. RA request form was made accessible to both RA and BD user and RA initiation form only to the RA user by configuring record types and access permissions.
RA Request Form: RA Request form was developed using Visualforce, which would be used to create Product Registration and Notification requests. It enabled the users to –
Create RA requests for product registration and notification
Select the product distribution county viz. European or other countries
Select the type of agreement signed between client and customer viz. Non-Disclosure Agreement, Term Sheet or Distribution Agreement
Add multiple BSKU information, which included item number, default item group, product family, brand name etc.
Add remarks for the created RA request
RA Initiation Form: RA Initiation form was developed using Visualforce, which would be used to create Project and Country regulatory activity requests. It enabled the users to –
Create project regulatory activity initiation requests for CE (Conformité Européenne) certification and product classification
Select the product distribution county viz. European or other countries
Select the type of agreement signed between client and customer viz. Non-Disclosure Agreement, Term Sheet or Distribution Agreement
Add multiple BSKU information, which included item number, default item group, product family, brand name etc.
Select a person in-charge for the RA initiation
Add remarks for the initiated activity
Request Approval History: Request Approval History functionality was developed to keep a log of approval process steps for originated RA requests and RA initiation requests. RA request form is accessible to a BD and RA users for approval whether RA initiation form is accessible to RA usera for approval.
Development and testing on the Developer Sandbox and moving to the Production Org
Extensive use of Visualforce pages, apex classes, validation rules, triggers and email templates
Deployment plans and change sets to deploy the application once completed
Coding using SFDC standards and best practices