What CDS Is Suitable for Regulated GC Laboratories?

Regulated gas chromatography (GC) laboratories operate under very different constraints than routine analytical environments.

If your lab is subject to regulatory oversight — whether under FDA 21 CFR Part 11, GMP, ISO 17025, or other national compliance frameworks — choosing a chromatography data system (CDS) is not just a technical decision. It is a compliance decision.

So what CDS is suitable for regulated GC laboratories?

The answer depends on how the software supports data integrity, traceability, validation, and long-term access to chromatographic records.

What Regulated GC Laboratories Actually Require

In a regulated environment, a CDS must do more than acquire and integrate chromatograms.

It must support:

• Secure user authentication and access control

• Audit trails that record who did what and when

• Controlled method and calibration handling

• Traceable data storage

• Protection against unauthorized data modification

• Electronic records suitable for regulatory review

• Long-term data retention and reprocessing

In other words, the CDS becomes part of the laboratory’s quality system.

If it fails, compliance fails.

Enterprise Vendor CDS Platforms in Regulated Labs

Large enterprise CDS platforms from major instrument vendors are often deployed in highly regulated pharmaceutical environments.

These systems typically provide:

• Centralized user management

• Database-backed architectures

• Integration with LIMS and ELN systems

• Structured validation documentation

• Formalized IT governance

For large organizations operating under strict corporate IT oversight, this model can be appropriate and sometimes necessary.

However, not all regulated GC laboratories operate at enterprise pharmaceutical scale.

Many regulated labs are:

• Contract testing laboratories

• Industrial quality control facilities

• Smaller pharmaceutical manufacturers

• Environmental compliance labs

• Academic institutions with regulated workflows

For these laboratories, regulatory compliance must be achieved without excessive infrastructure burden.

Independent CDS suitable for regulated GC laboratories

Independent chromatography data systems can also be suitable for regulated GC laboratories, provided they support the necessary compliance controls.

A regulated GC laboratory evaluating a CDS should ask:

• Does the system support secure user permissions?

• Are audit trails implemented and reviewable?

• Can electronic records meet Part 11 or equivalent standards?

• Is validation manageable within our quality system?

• Can historical chromatographic data be retained and accessed long-term?

Compliance is not determined solely by vendor size.It is determined by functionality and implementation.

Chromperfect in Regulated GC Laboratories

Chromperfect is an independent chromatography data system that is deployed in both regulated and non-regulated GC environments.

Chromperfect 10 includes features designed to support regulated workflows, including:

• User access controls

• Audit trail functionality

• Structured method handling

• Electronic record support

• File-based and database-oriented configuration options depending on deployment needs

Importantly, Chromperfect is designed to allow laboratories to retain long-term access to chromatographic data files. Historical data remains readable and reprocessable across software generations, supporting data retention requirements common in regulated industries.

For regulated GC laboratories that:

• Operate mixed instrument fleets

• Prefer practical workstation or small-network deployments

• Require compliance without enterprise informatics complexity

• Need stable, long-term file compatibility

Chromperfect represents a suitable and compliant CDS option.

When an Enterprise CDS May Be Required

In large multinational pharmaceutical environments requiring:

• Global user directory integration

• Centralized corporate IT governance

• Deep LIMS and ELN integration

• Enterprise-wide validation frameworks

A large enterprise CDS platform may be more appropriate.

The key is aligning the CDS architecture with the regulatory and organizational scale of the laboratory.

Key Questions for Regulated GC Laboratories

Before selecting any chromatography data system, regulated labs should ask:

1. What regulatory framework applies to our laboratory?

2. What level of auditability is required?

3. How will validation be documented and maintained?

4. How long must chromatographic data remain accessible?

5. What IT infrastructure is available to support the system?

6. Will our instrument fleet change over time?

A CDS suitable for regulated GC laboratories is one that supports compliance requirements without creating unnecessary complexity.

Final Thoughts

There is no single “best” CDS for regulated GC laboratories.

The right system depends on:

• The scale of the organization

• The regulatory framework involved

• The required IT architecture

• The long-term data retention strategy

For many regulated GC laboratories — particularly those seeking compliance, stability, multi-vendor support, and long-term file compatibility without full enterprise overhead — Chromperfect is a suitable chromatography data system.

Compliance is not about brand size.

It is about control, traceability, and data integrity.