Digital Calibration Certificates (DCC)
Definition, benefits, and implementation guide for GxP
Jakob Konradsen
Digital Calibration Certificates can replace manual PDF processing with machine-readable XML files that feed directly into your quality system. This guide explains what DCCs are, their benefits and risks for pharmaceutical and healthcare logistics operations, and what to consider before implementation.
Get a practical tool to assess your operation's readiness.
What are Digital Calibration Certificates?
A Digital Calibration Certificate (DCC) is a machine-readable calibration certificate in XML format that meets the ISO/IEC 17025 requirements (in terms of required contents in a calibration certificate) and can be automatically processed by IT systems.
DCCs differ from PDF certificates in three critical ways:
Machine-readable: Data can be automatically extracted and transferred into your CMMS, ERP, or quality management systems without manual entry.
Machine-interpretable: The system understands what each data point means (measured value, uncertainty, calibration date, equipment ID) and can correctly assign and process it without human interpretation. Each DCC has a unique identifier, and furthermore holds specific identification of the equipment that was calibrated.
Cryptographically signed: Digital signatures can ensure authenticity and integrity, making tampering immediately detectable.
The DCC schema has been co-developed under the leadership of Germany's Physikalisch-Technische Bundesanstalt (PTB) with input from national metrology institutes, accreditation bodies, and industry stakeholders worldwide. The current version (3.3.0) provides long-term stability and is already being offered by some calibration providers globally.
Also read: ISO 17025 in temperature compliance: what you need to know
Why pharmaceutical companies could benefit from using DCCs
Pharmaceutical manufacturers and healthcare logistics operators manage calibration at scale. A mid-sized pharmaceutical company may require hundreds of thousands of calibration certificates annually across multiple sites, equipment types, and regulatory jurisdictions.
Current manual processes create several pain points:
Time-consuming data entry: Calibration results must be manually transcribed from PDF certificates into quality management systems, often requiring four-eyes verification to ensure accuracy.
Data integrity risk: Manual transcription introduces the possibility of data entry errors, which can compromise ALCOA+ principles and create compliance gaps during audits.
Complex traceability: Tracking calibration chains across multiple vendors, sites, and equipment becomes difficult when data exists in disconnected PDF files rather than structured database records.
Audit burden: Auditors (both internal and external) must manually verify calibration records, cross-reference equipment IDs, check dates, and confirm traceability – a process that can take hours per audit.
Vendor fragmentation: Large operations typically work with 15–50 different calibration providers, each with slightly different certificate formats despite following the same ISO/IEC 17025 standard.
Requirements drifting: International large organizations with distributed quality roles in different countries and regions have an inherent risk of calibration requirements drift. By having a global repository of digital calibration requirements, compliance and harmonization can be ensured across the organization.
DCCs address these challenges by enabling end-to-end digitalization of calibration data workflows. The impact is particularly significant in GMP and GDP environments where data integrity requirements are stringent, and audit frequency is high.
6 benefits and 6 risks of implementing DCCs
Benefits
- Automated data transfer: Calibration results flow directly from the calibration provider into your CMMS or ERP system, eliminating manual entry and four-eyes verification.
- Error elimination: Machine-to-machine data transfer removes transcription errors. Data integrity is cryptographically guaranteed rather than dependent on manual verification processes.
- Complete digital traceability: Digital records create an unbroken calibration chain from your equipment through reference standards to national measurement standards.
- Faster audit preparation: Auditors can query digital records directly, verify cryptographic signatures, and trace calibration chains without manually reviewing individual certificates. Organizations report audit preparation time reductions from days to hours.
- Improved ALCOA+ compliance: DCCs inherently support Attributable, Legible, Contemporaneous, Original, and Accurate principles through their structured format, digital signatures, and audit trail capabilities.
- Better calibration management: Structured data enables trend analysis, predictive maintenance scheduling, and data-driven decisions about calibration intervals and equipment performance.
Risks
- Format fragmentation: Multiple DCC implementations exist. While the PTB-led schema is the most widely adopted, regional variations and proprietary formats create interoperability concerns. Choosing the wrong format may require future migration.
- System compatibility requirements: Your current CMMS, ERP, or quality management system may not support DCC import without middleware or software updates. Integration requirements vary significantly by platform and vendor.
- Standardization uncertainty: International standardization efforts are ongoing but not complete. The format continues to evolve, and backward compatibility – while prioritized – is not guaranteed across major version changes.
- Validation workload: In GxP environments, implementing DCCs typically requires validation of the entire digital workflow, something that can be time-consuming and would require updating when new schemas are released.
- Provider readiness varies: Not all calibration laboratories offer DCCs. Those that do may use different schema versions or regional implementations, creating a patchwork of formats if you work with multiple providers.
- Change management complexity: Moving from paper or PDF workflows to fully digital processes requires careful planning, staff training, SOP updates, and parallel operations during transition.
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Where Digital Calibration Certificates provide the most value
DCCs deliver the greatest benefits in operations with high calibration volumes, multiple sites, or complex regulatory requirements.
Multi-site pharmaceutical manufacturing
Companies operating production facilities across multiple countries face the challenge of harmonizing quality processes while complying with local regulations. DCCs enable centralized quality teams to monitor calibration status across all sites in real time, identify outliers, and ensure consistent documentation standards without manual consolidation.
With the use of digital calibration requirements (DCRs), these requirements can be made global; thereby harmonized with global QA requirements.
Healthcare logistics with CEIV Pharma certification
Pharmaceutical logistics operators pursuing or maintaining CEIV Pharma certification must demonstrate robust temperature monitoring and calibration programs across their network. DCCs simplify the documentation burden by providing auditors with complete, structured calibration records for all monitoring equipment at every facility.
Also read: Good Distribution Practice (GDP): requirements and guidelines for pharma
Contract development and manufacturing organizations (CDMOs)
CDMOs serve multiple clients with different quality agreements and calibration requirements. DCCs make it easier to customize reports, prove compliance with client-specific standards, and provide transparent traceability without manual document preparation for each customer.
High-throughput laboratory environments
Analytical laboratories operating hundreds of instruments (balances, pipettes, temperature chambers, analytical equipment) benefit significantly from automated calibration data management. DCCs enable efficient scheduling, automatic flagging of out-of-tolerance conditions, and streamlined recalibration workflows.
Validation-intensive startups
Emerging pharmaceutical and biotech companies building their quality infrastructure from scratch can implement DCC-based workflows from day one, avoiding the technical debt and process inefficiencies that come from paper-based systems.
Are DCC formats standardized?
The DCC concept has matured significantly, but full global harmonization remains a work in progress as of January 2026.
Current standardization status
The PTB-led DCC schema (version 3.3.0) is the most widely recognized format and has been adopted by metrology institutes and calibration laboratories in Germany, Denmark, Finland, and other European countries. The schema meets ISO/IEC 17025 requirements and has been validated in industrial pilot projects across automotive, pharmaceutical, and process industries.
European standardization is advancing through EURAMET's TC-IM working group 1448, chaired by Denmark's DFM (Danish Fundamental Metrology). This group focuses on harmonizing DCC implementation across EU member states.
Why harmonization matters
Without standardized formats, efficiency gains erode. If your calibration providers use three different DCC formats, you need three different integration solutions – or middleware that can translate between formats. Harmonized standards ensure universal machine readability, reduced integration costs, long-term stability through coordinated version management, and regulatory acceptance by authorities like FDA, EMA, and MHRA.
Competing approaches
Several regional and industry-specific variations exist:
DCX format: Developed by DFM in Denmark, this format addresses specific use cases not fully covered by the PTB schema.
National implementations: Some countries have created their own DCC specifications that are compatible with but not identical to the PTB schema.
Vendor-specific formats: Some calibration equipment manufacturers and software providers have developed proprietary digital certificate formats that may or may not be compatible with the standardized DCC schema.
The metrology community is actively working to converge these approaches. The 5th International DCC Conference in February 2025 brought together stakeholders to address interoperability, share implementation experiences, and coordinate future development.
What you need to implement Digital Calibration Certificates
Implementing DCCs successfully requires planning across technical, compliance, and operational dimensions.
1. Technical readiness
System compatibility assessment: Evaluate whether your current CMMS, ERP, or quality management system can import and process XML-based DCCs. Laboratory Information Management Systems (LIMS) typically have better XML handling, while enterprise systems may require middleware or custom development.
Key questions: Can our system parse XML files automatically? Do we have validation frameworks for new data import methods? What is our approach to digital signature verification?
Data mapping requirements: Determine how DCC fields map to your existing database schema. Equipment IDs, calibration point labels, and uncertainty expressions may need translation logic.
Infrastructure for digital signatures: DCCs rely on cryptographic digital signatures for authenticity. Your IT infrastructure must be able to validate these signatures, which may require certificate authority integration and public key infrastructure (PKI) setup.
Storage and archiving strategy: Plan for long-term storage of both the XML files and human-readable versions. GxP regulations typically require retention periods of 5–10+ years with full audit trail capabilities.
2. Compliance validation requirements
In GxP environments, changes to data workflows typically require validation. This includes system qualification (validating software that generates, transfers, and processes DCCs according to GAMP 5 principles), data integrity controls (demonstrating ALCOA+ compliance throughout the DCC lifecycle), audit trail requirements (logging all interactions with DCC data), and electronic signature compliance (21 CFR Part 11 or EU Annex 11).
3. Provider coordination
Format alignment verification: Confirm which DCC schema version your calibration providers support. Ask: Which DCC schema version do you use? Can you provide sample DCCs for testing? Do you support both accredited and traceable calibrations in DCC format?
Transition planning: Establish a realistic timeline for moving from PDF to DCC delivery. Most organizations run parallel processes during transition periods of 6–12 months.
Service agreement updates: Update contracts and quality agreements to specify DCC delivery, schema versions, signature requirements, and validation documentation needs.
4. Organizational change management
Staff need training on DCC authenticity verification, troubleshooting import issues, and system alert response. Update SOPs to reflect digital workflows, including system interactions, error handling, and deviation management. Engage QA managers, IT teams, calibration coordinators, validation specialists, and auditors early to reduce resistance and identify issues before they become blockers.
Easy transfer to DCCs with Eupry
How it works
Eupry's calibration solution includes DCC delivery as part of our integrated compliance platform.
When we calibrate your data loggers – either as part of continuous monitoring setups or mapping studies – calibration data is available in both traditional PDF format and machine-readable DCC format.
This means you can transition to digital workflows at your own pace, expanding as your systems and processes are ready.
Our approach addresses several common implementation challenges:
- Format stability: We follow the PTB-led DCC schema and maintain backward compatibility as the standard evolves.
- Validation support: We provide the documentation and testing support needed for GxP system qualification, including sample DCCs, validation protocols, and technical specifications.
- Integrated platform: Calibration data flows directly into our monitoring and mapping platform, creating a unified source of truth for all temperature compliance activities.
- Flexible delivery: You receive both the XML DCC file and a human-readable PDF, giving you the machine-readable benefits without losing the familiar certificate format during your transition.
Ready to transition to digital calibration workflows?
DCCs are being implemented by pharmaceutical manufacturers and logistics operators worldwide. The question is not whether to adopt digital calibration certificates, but when and how to do it strategically.
Download our DCC implementation checklist to evaluate your organization's readiness, identify system requirements, and build a practical transition plan.
