Compliance Package for VisualSpreadsheet

Ensure 21 CFR Part 11 compliance with FlowCam subvisible particle analysis

The Compliance Package for VisualSpreadsheet® is a software add-on for FlowCam instruments to enable regulatory compliance and enhance data integrity for subvisible particle analysis. The 21 CFR Part 11 software package adds several technical controls to VisualSpreadsheet for regulatory compliance, including a user login, a customizable user permission system, electronic signatures, a searchable audit trail, and secure data archival.

With the 21 CFR Part 11 Compliance Package, you can rest assured with the ability to control system access, log user actions, and safeguard FlowCam data. This add-on enables organizations to meet regulatory requirements while enhancing the security, traceability, and integrity of their particle measurements.

Request a Quote

Download the White Paper

A scientist in a lab coat in a biopharmaceutical laboratory setting using a laptop computer This photostyle image should be overlaid with imagery conveying software compliance That imagery should include the text 21 CFR Part 11 Compliance The scienti-3

The Compliance Package: Meeting Federal Data Regulations

  • Ensure Data Security: Prevent unauthorized access to and manipulation of FlowCam data with a secure user login system. Detect invalid, corrupted, or altered files using an automated checksum whenever data is accessed.

  • Enforce Standard Operating Procedures: Tailor each user’s software access to organizational needs with a customizable permissions system. Require authentication or supervisor approval for certain actions through electronic signatures.

  • Capture Data with Integrity: Document all system activity in detail within a timestamped audit trail. Use search tools to reconstruct the who, what, where, when, why, and how of data collection activities.

  • Store Data Securely: Retain and recall all FlowCam data for its retention period, and beyond, through a secure archival process.

The Compliance Package enables researchers to operate FlowCam instruments and process FIM data in a secure, traceable, and auditable manner per 21 CFR Part 11 requirements.

Our white paper, Ensuring 21 CFR Part 11 Compliance with FlowCam, provides an overview of the regulation and describes how the Compliance Package’s technical features align with the requirements outlined in 21 CFR Part 11 Subparts B and C. 

Download the White Paper

pdf-thumbnail-compliance-package-white-paper

Is FlowCam right for you?

  • Get in Touch

    Tell us about your application and particle characterization needs.

  • Have a conversation

    We're happy to set up a call to discuss the proper FlowCam configuration for your application.

  • We'll send you a quote

    We'll follow up to discuss the quote and can set up a seminar, demonstration, or sample analysis

Request a Quote