Understanding FDA Expectations
Organizations operating under FDA regulations should consult their internal Quality Assurance (QA), Regulatory Affairs, or Compliance departments when determining the suitability of software tools for regulated workflows.
Acceptance of software used in qualification programs depends on how the software is implemented, validated, controlled, and documented within the organization's quality system.
Is Excel Accepted in Regulated Laboratories?
Microsoft Excel is widely used throughout pharmaceutical, biotechnology, environmental, academic, and analytical laboratories.
In general, FDA-regulated organizations may utilize Excel-based tools when appropriate controls are established to ensure data integrity, traceability, accuracy, and compliance with applicable regulations.
Examples of commonly implemented controls include:
- User access controls
- Version management
- Validation procedures
- Document control systems
- Data backup procedures
- Audit trail controls where applicable
- Quality Assurance oversight
The suitability of Excel within a regulated environment ultimately depends on the laboratory's internal compliance framework and operating procedures.
Excel Software Included with Chemical Solutions™ Qualification Kits
The Excel software supplied with Chemical Solutions™ HSQ Kit™ and PQ Kit™ products is designed to assist laboratories with qualification workflows and data analysis.
These spreadsheets support:
- Qualification calculations
- Performance data evaluation
- Result documentation
- Standardized reporting
The software is intended to work alongside established laboratory procedures and validated chromatography data systems.
Data Integrity and Quality System Considerations
Data integrity remains the responsibility of the laboratory using the qualification software.
Organizations should establish procedures that address:
Software Validation
Qualification spreadsheets should be evaluated according to internal validation requirements and quality procedures.
User Access Control
Organizations should manage access to qualification files according to their established policies.
Change Management
Revisions and modifications should be documented and controlled where required by laboratory procedures.
Record Retention
Qualification data and associated records should be maintained in accordance with applicable regulatory requirements and company policies.
Relationship to 21 CFR Part 11
Many laboratories operate under 21 CFR Part 11 requirements for electronic records and electronic signatures.
Compliance with Part 11 involves more than the spreadsheet itself and typically includes:
- Controlled electronic systems
- User authentication
- Electronic signatures
- Audit trails
- Validation protocols
- Procedural controls
Laboratories should determine how qualification software fits within their overall compliance strategy and quality management system.
Validation Documentation
To support quality and compliance reviews, validation documentation may be available for qualification software used with Chemical Solutions™ Qualification Kits.
This information can assist organizations during:
- Internal quality reviews
- Qualification audits
- Validation assessments
- Regulatory inspections
- SOP development
Laboratories should evaluate available documentation according to their internal review procedures.
Key Takeaways
- FDA acceptance depends on how Excel is controlled and managed within a laboratory's quality system.
- Excel is commonly used in regulated analytical laboratories.
- Data integrity, validation, and procedural controls are essential considerations.
- Chemical Solutions™ qualification spreadsheets support qualification calculations and reporting activities.
- Organizations should consult their QA and regulatory teams regarding internal compliance requirements.
- Validation documentation may be available to support qualification and review activities.