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Frequently Asked Questions

About ApprovalFlow

ApprovalFlow is a secure, cloud-based platform specifically designed to meet the rigorous demands of the pharmaceutical industry, streamlining the review and approval of documents, promotional materials, and artwork. Recognising the critical need for compliance in this regulated sector, ApprovalFlow allows users to easily upload their files and utilise a structured, sequential workflow that mirrors industry best practices for approval processes. Within this workflow, each reviewer can add annotations directly to the document. To maintain strict compliance and full traceability, ApprovalFlow securely locks these annotations to the individual user, preventing any unauthorised removal or alteration by others, thus ensuring adherence to pharmaceutical regulations like 21 CFR Part 11.

ApprovalFlow streamlines document approvals into three simple steps: upload your document, add comments and markup directly within the platform, and submit it for review. Reviewers can then select from "Approved," "Approved with Changes," or "Resubmit." Choosing "Resubmit" returns the document to the originator for further edits. Throughout the process, ApprovalFlow's automated email system keeps everyone on track, notifying each reviewer when it's their turn. Once all approvals are granted, a final version of the document is uploaded. To ensure ongoing accuracy, an expiry date is assigned to each document, triggering automated notifications to the originator when the document nears expiration and requires updating and resubmission for a new review cycle.

ApprovalFlow's structured approval workflow offers several benefits.

  • Improved compliance
  • Faster document review cycles
  • Cost savings
  • Enhanced team collaboration

ApprovalFlow improves compliance by providing a structured digital workflow and a detailed audit trail. Traditional word processors use "track changes" to manage version edits. When a reviewer accepts all changes, the comments are lost, and it becomes unclear what changes users made. The annotation view in ApprovalFlow enables users to add comments and markup to documents directly in the browser. These comments are locked to individual users, offering full traceability from an audit perspective.

ApprovalFlow's digital workflow speeds up the approval process. With drag-and-drop functionality, users can add new documents with ease. The automated email notification system alerts reviewers when it is their turn to approve a document.

ApprovalFlow removes the need to print, store and archive physical documents, which results in cost savings. The digital workflow in ApprovalFlow ensures that the entire document review and approval process is managed within the browser, without the need to download and re-upload documents.

The automated notification system and timeline feature optimise collaboration between team members. The notification system alerts reviewers when it is their turn to approve a document. The timeline feature in ApprovalFlow tracks all user interactions and keeps users informed throughout the process.

ApprovalFlow enhances compliance for pharmaceutical companies by providing a fully traceable and auditable history of all document approvals. Every step of the review process, including annotations, comments, approvals, and rejections, is meticulously recorded and time-stamped. This comprehensive audit trail ensures accountability, simplifies regulatory audits and demonstrates adherence to stringent industry standards like 21 CFR Part 11.

ApprovalFlow is committed to maintaining the highest standards of data security and compliance. The platform is hosted on Amazon Web Services (AWS), a leading cloud provider known for its robust security infrastructure. We leverage Amazon EC2 for hosting and Amazon S3 Glacier for reliable data backups. All customer data is protected with encryption, both in transit over public networks and at rest within our secure environment. Furthermore, ApprovalFlow supports multi-factor authentication (MFA) through integration with trusted providers like Microsoft Azure Active Directory (Authenticator) and Google Authenticator, providing an additional layer of security and ensuring that only authorized users can access sensitive information. This comprehensive approach to security helps our clients meet their compliance obligations and maintain the trust of their customers.

Review process

The document review process in ApprovalFlow is designed for clarity and control. It begins with the document originator uploading the file and initiating a review cycle. The system then automatically routes the document to the designated reviewers based on the pre-configured workflow. Reviewers can access the document directly in their browser, using integrated annotation tools to add comments, highlights, and markups. They can then choose to "Approve," "Approve with Changes," or "Resubmit" the document back to the originator for revisions. This process continues, guided by automated email notifications, until all required approvals are obtained, resulting in a finalised document with a complete audit trail.

ApprovalFlow includes workflow controls for skipping and delegating participants in a review.

SKIP:

The SKIP function in a workflow allows an assigned reviewer or approver to be bypassed in the approval process. This is useful when a specific individual is unavailable or their input is no longer required for a particular document or stage. When a user is skipped, the workflow automatically progresses to the next designated reviewer or approver, ensuring that the review process continues without unnecessary delays. The SKIP function maintains efficiency while providing flexibility to adapt to changing circumstances, but it is often subject to certain permissions or rules to prevent misuse and maintain proper control over the approval process. An audit trail would log any instance of a user being skipped.

DELEGATE:

The DELEGATE function enables a user to temporarily assign their review or approval responsibilities to another authorised user. This is particularly helpful when someone is out of the office, on vacation, or otherwise unable to complete their tasks within the required timeframe. By delegating their authority, the original user ensures that their pending approvals don't become a bottleneck in the workflow. The delegated user can then review and approve documents on behalf of the original user, maintaining the flow of the approval process. Once the delegation period ends or the task is completed, the responsibility reverts back to the original user. The DELEGATE function promotes continuity and responsiveness, all while preserving accountability by keeping a record of the delegation in the audit trail.

The Reserve function enables an originator to essentially "pre-register" a document within the system by reserving a unique identification number. At this stage, the originator may only need to input minimal information, such as a document title or a brief description. The system then assigns the next available number in the designated sequence, preventing any other user from claiming it. This initial step ensures that the document's place in the numbering system is secured, even before the content or the review workflow is fully defined.

Benefits of the reserve function:
  • Sequential numbering integrity: This function is vital in industries or processes that require strict document control and sequential numbering. It guarantees that numbers are assigned chronologically and without gaps, even if the document creation and review process takes time.
  • Placeholding for future documents: Originators can reserve numbers for documents that are planned but not yet drafted, allowing them to organize and plan their documentation in advance.
  • Flexibility in workflow: It decouples document number assignment from the document upload and review process. This allows for greater flexibility, as originators can secure the number first and then finalize the document content and reviewer list later.

There may be times when the review of a specific document is no longer required. The withdraw function in ApprovalFlow enables the originator to withdraw the document. When the withdraw function is triggered, the timeline is updated, and the document is moved from active documents to completed documents.

The recall function enables the originator to stop the current review cycle. New information may require changes to the document. Instead of wasting the reviewers time with an incorrect version of the document, the originator recalls the document and resubmits the updated version. When the recall function is triggered, the timeline is updated, and the review step reverts to the originator.

ApprovalFlow's "Share" function enables originators and reviewers to grant read-only access to a document review with other system users. Once shared, the recipient receives an automated email notification, allowing them to view the document, its current status, and all associated comments. This "watcher" role provides visibility into the review process without granting annotation or approval privileges, making it ideal for keeping stakeholders informed without impacting the defined workflow. The originator or reviewer retains the ability to revoke this access (un-share) at any time.

ApprovalFlow offers a flexible document numbering system, automatically assigning a unique identifier to each new document. While the standard format includes the product name, country code, and a sequential five-digit number (e.g., ABC-AU-00001), this can be tailored to your specific needs. The general settings page provides options to simplify the document number by removing the product and country codes, leaving only the sequential number.

Recognising the importance of compliance in regulated industries, ApprovalFlow incorporates rigorous version control into its document review workflow. Each review iteration requires the originator to upload a new version of the document, ensuring a clear history of changes. To maintain an audit-ready record, comments and markup applied to earlier versions are locked and preserved. This provides a complete, chronological trail of all user interactions with the document, demonstrating adherence to regulatory requirements.

At the conclusion of a review cycle, ApprovalFlow enables originators to easily share a comprehensive PDF version of the marked-up document with stakeholders or external agencies. The platform's export function compiles all comments, annotations, and markup elements into a single, downloadable PDF file. This ensures that all feedback and changes are captured in a readily shareable format.

ApprovalFlow equips administrators with powerful reporting tools to monitor system usage and performance. Individual user dashboards provide a real-time view of each user's activity, including their active and completed document count and average monthly processing rate. The platform also offers a centralized reporting dashboard that aggregates data across all users, providing a holistic view of system-wide document activity. All this data is readily available for download in CSV format, enabling detailed analysis and reporting.

Subscription information

ApprovalFlow offers both a cost-effective monthly subscription and a scalable Enterprise solution. The monthly subscription, with its fixed per-user fee, provides an accessible entry point for teams of all sizes. Our Enterprise plan, designed for larger organizations, includes a dedicated server instance and a fixed monthly fee, ensuring optimal performance and security. To discuss your specific needs and receive Enterprise pricing details, please reach out to our sales team at sales@approvalflow.net.

Our monthly subscription is based on the number of users who will need access to ApprovalFlow. Each user will require a separate license, and the monthly fee is calculated accordingly.

Yes, you can easily add or remove users from your monthly subscription as your team's needs change. Your monthly fee will be adjusted accordingly. Please refer to your account settings for user management.

The monthly subscription is a cost-effective solution suitable for most teams. The Enterprise plan offers a dedicated server instance, advanced customization options, and enhanced support, making it ideal for larger organizations with specific security or performance requirements.

Pharmaceutical companies operate in a highly regulated environment with stringent compliance requirements, making ApprovalFlow's Enterprise model the ideal solution. This plan provides a dedicated server instance, ensuring data isolation and enhanced security, crucial for safeguarding sensitive information and meeting regulatory demands like 21 CFR Part 11. The Enterprise model also offers advanced customization options, allowing companies to tailor the platform to their specific compliance workflows and validation procedures, simplifying audits and demonstrating adherence to industry best practices.

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