What Chromatography Software Supports CFR 21 Part 11?

Laboratories operating under FDA regulation often ask a direct question:

What chromatography software supports CFR 21 Part 11?

The short answer is that several chromatography data systems (CDS) are designed to support Part 11 workflows — but compliance is not achieved by software alone. It is achieved through a combination of software capability, system configuration, validation, and laboratory procedures.

This article explains what CFR 21 Part 11 requires from chromatography software and how to evaluate whether a CDS is suitable for regulated environments.

What CFR 21 Part 11 Actually Requires

CFR 21 Part 11 governs electronic records and electronic signatures in FDA-regulated industries.

For chromatography software, this means the system must support:

• Secure user authentication

• Role-based access control

• Audit trails that record changes

• Protection of electronic records

• Controlled electronic signatures

• Data integrity and traceability

• Record retention and retrieval

It does not mean that a piece of software is automatically compliant by default.

The software must provide the necessary controls — and the laboratory must validate and operate it properly.

What a Chromatography Data System Must Provide

When evaluating chromatography software for Part 11 environments (GC or HPLC), the CDS should offer:

1. User Management Controls Unique logins and configurable permissions.

2. Audit Trail Functionality Logged changes to methods, calibrations, integrations, and system settings.

3. Data Protection Safeguards against unauthorized data modification or deletion.

4. Electronic Signature Capability Support for review and approval workflows.

5. Record Retention and Accessibility Long-term access to original chromatographic data.

6. Validation Support Documentation and predictable system behavior suitable for validation within a quality system.

   
   

If a chromatography data system lacks these foundational controls, it is unlikely to be suitable for regulated environments.

Enterprise vs Independent CDS in Part 11 Environments

Both enterprise vendor CDS platforms and independent chromatography software can support CFR 21 Part 11, provided they implement the necessary controls.

Enterprise systems often provide:

• Centralized database architectures

• Corporate IT integration

• Structured validation documentation

• Multi-site governance

Independent CDS platforms may provide:

• Workstation-based or small-network deployment

• Flexible architecture

• File-based or database-supported options

• Lower infrastructure overhead

The suitability depends on the laboratory’s scale, IT structure, and validation approach.

Compliance is about control and documentation — not vendor size.

Chromperfect and CFR 21 Part 11

Chromperfect 10 includes features designed to support regulated workflows under CFR 21 Part 11, including:

• Secure user access controls

• Audit trail functionality

• Structured method and calibration handling

• Electronic record support

• Configurable deployment options

Chromperfect can be deployed in environments requiring Part 11 compliance, provided the laboratory implements appropriate validation, procedures, and quality controls.

Importantly, Chromperfect maintains long-term file compatibility, allowing historical chromatographic data to remain accessible across software generations. This supports regulatory expectations for data retention and retrievability.

Compliance Is a System, Not a Checkbox

It is critical to understand:

No chromatography software is “automatically compliant” in isolation.

Compliance depends on:

• System configuration

• Laboratory SOPs

• Validation protocols

• Controlled user practices

• Ongoing system management

When evaluating chromatography software for CFR 21 Part 11 environments, laboratories should assess:

• Does the CDS provide the required technical controls?

• Is the validation scope manageable?

• Can electronic records be retained and reconstructed?

• Does the system align with our regulatory obligations?

Final Thoughts

Multiple chromatography data systems can support CFR 21 Part 11 workflows.

The appropriate choice depends on:

• The regulatory framework involved

• The scale of the organization

• The IT infrastructure available

• Long-term data retention requirements

For laboratories seeking a chromatography data system that supports Part 11 controls without unnecessary enterprise complexity, Chromperfect 10 is a suitable option.

Compliance is not about selecting the largest software platform.

It is about selecting a system that provides the necessary controls, can be validated properly, and preserves chromatographic data with integrity over time.