VisualSpreadsheet 6.1 Comprehensively Supports 21 CFR Part 11 Compliance
Operating in a GMP environment requires more than accurate particle measurements – it demands confidence in data integrity, traceability, and regulatory compliance. For pharmaceutical manufacturers and QC laboratories, this means ensuring that all electronic records and signatures meet the standards outlined in 21 CFR Part 11, a regulation enforced by the FDA.
To support these requirements, VisualSpreadsheet 6.1 now offers an optional Compliance Package that enables secure, auditable, and fully traceable data handling. Designed for use with flow imaging microscopy (FIM) instruments such as FlowCam 8100 and FlowCam LO, which are often incorporated into lot release testing, this package provides the technical controls needed to confidently operate in FDA-regulated environments.
For a detailed review, see our white paper:
Ensuring 21 CFR Part 11 Compliance with FlowCam
Why 21 CFR Part 11 Matters
21 CFR Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. To comply, systems must:
- Attribute actions to specific users
- Restrict access to authorized personnel
- Control access to records and software features
- Maintain a secure, timestamped audit trail
- Support electronic signatures that are secure, verifiable, and legally binding
Read the full guidance from the FDA here
How the Compliance Package Supports GMP Workflows
The Compliance Package for VisualSpreadsheet goes beyond minimum regulatory requirements to help users meet their data integrity goals with confidence. Key features of 21 CFR Part 11 include:
- Electronic Signature System: Log user actions and supervisor approvals on record creation and modification, ensuring accountability and traceability.
- Role-Based Access Control: Restrict access to sensitive features by assigning permissions based on user roles.
- Tamper-Evident Audit Trail: Automatically record all user actions with time stamps in a secure, searchable format.
- Customizable User Permissions: Define who can acquire, access, modify, approve, or view data - and when electronic signatures are required.
- Data Archival and Retention Tools: Securely store and retrieve instrument records throughout their retention period to support inspections and audits.
Together, these features enable pharmaceutical teams to maintain compliance while streamlining workflows and minimizing risks.
Pharmaceutical Quality Control Testing with FlowCam LO and the 21 CFR Part 11 Compliance Package
Monitoring subvisible particulates (SVPs) is essential for ensuring the safety and quality of protein-based therapies and other biologics. USP <788> mandates the use of light obscuration (LO) for quantifying particles ≥10 µm and ≥25 µm in parenteral products. FIM, recommended in USP <1788>, complements LO by capturing high-resolution images and detailed morphological data. This enables researchers to distinguish between protein aggregates, silicone oil droplets, and other particulate matter, providing critical insights for enhancing quality control and root cause analysis.
FlowCam LO combines both techniques in a single instrument, enabling users to collect USP <788> compliant LO data and USP <1788> recommended FIM data from the same sample. This dual capability:
- Streamlines workflows
- Reduces sample consumption
- Enhances data richness
- Improves confidence in particle characterization
When coupled with the 21 CFR Part 11 Compliance Package for VisualSpreadsheet, FlowCam LO becomes a powerful solution for GMP environments. The Compliance Package enables:
- Electronic Signature System:
Securely log user actions and supervisor approvals on record creation and modification. Signatures are permanently linked ot records and include the user's name, timestamp, and purpose of action. - Role-Based Access Control:
Assign users to predefined or custom roles that define which features they can access, modify, or approve - ensuring only authorized personnel can perform critical actions. - Custom Role Creation:
Administrators can create new roles tailored to organizational SOPs, enabling granular control over permissions and workflows. - Tamper-Evident Audit Trail:
Automatically record all user actions in a secure, time-stamped, append-only audit trail. Prior entries are never overwritten or deleted. - Automated Data Integrity Checks:
Each time a record is accessed, VisualSpreadsheet performs a checksum-based validation to detect tampering or corruption. Altered records are automatically flagged, and a warning message is displayed whenever that record is opened. - Secure Data Archival and Retention:
Store FlowCam data and audit trails in encrypted archives or local databases. Records are retained indefinitely and can be exported in human-readable formats (PDF, CSV) for regulatory review. - Closed System Architecture:
Designed to operate as a closed system per 21 CFR Part 11 definitions, the system minimizes risk and simplifies compliance. - Unique User Credentials:
Each user is assigned a unique ID and password. The system prevents reuse or reassignment of credentials.
Below is a table of default roles and permissions for a select subset of highlighted features of the 21 CFR Part 11 Compliance Package for VisualSpreadsheet (an additional 'Viewer' role, which can only view records and the audit trail, is not reflected in the table):
FlowCam provides a highly integrated and flexible solution for regulated environments. Its ability to perform both LO and FIM in one workflow - combined with robust compliance features - makes it uniquely suited for lot release testing, stability studies, and other FDA-regulated environments.
For more information, download our whitepaper:
