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The Countable PCR platform supports your 21 CFR Part 11 compliance – with key features built right into the software
Countable Control Software, part of the Countable PCR platform, now provides technical capabilities that support your compliance with 21 CFR Part 11 — such as secure audit trails, electronic signatures, and access controls.
Unlike in other genomics platforms, Countable Control Software has many 21 CFR Part 11 supporting features built right into the software — helping you stay compliant and eliminating the need for an extra software package or overlay.
Learn how the Countable PCR platform supports your organization’s adherence to the key regulatory requirements, so your team can focus on science, not software gaps.
Compliance with 21 CFR Part 11 involves both technical and procedural requirements
Countable Control Software contributes to fulfilling key technical requirements with:
- Centralized user management — one set of user permissions is used across multiple devices to save time, reduce redundancy, and lower the risk of mismatched permissions
- Signatures are appended directly to summary reports — approvals and attestations are done without exporting or moving data to another system, ensuring a seamless, auditable record trail
- Captured and easy to interpret changes with who, what, and when — users and auditors never have to worry about data source ambiguity
- Data protection against unauthorized edits — your results are safe and traceable in regulated settings
Integrated 21 CFR Part 11 technical features give you peace of mind
Let us help you meet complex regulatory requirements more confidently — with embedded compliance features that support your internal quality systems.
Learn more about how Countable Control Software satisfies 21 CFR Part 11 requirements.
