Compliance

One of the most pressing challenges labs face is ensuring that they meet critical compliance standards, both for the security of their data, and to avoid costly audit problems. RURO includes support for 21 CFR Part 11 and Annex 11 Electronic Signature & Audit Trail requirements in all its applications. RURO compliance services also include in-house validation and more through RURO’s ISO 9001 certified operational teams. By collaborating closely with your facility, RURO ensures that your solution meets your functionality objectives and that your labs fulfills its requirements to maintain or achieve compliance.

Perhaps the most valuable aspect of RURO compliance is its complement to the company’s services and software portfolio. Customers requiring nearly any level of industry compliance support, including 21 CFR Part 11, HIPAA, FISMA, Section 508 or who are pending certification in CLIA, CAP or COLA will find that RURO provides all the software and services they require. Contact us for more information on RURO compliance.

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Supporting CLIA Compliance

Quality Control

RURO products can be configured to generate Levey-Jennings reports for Quality Control using the
data stored securely within your solution. This eliminates the needs for secondary software or manual
data compilation.

Security

Access permissions ensure that only certain users have access to sensitive information and functionality elements in RURO software. The client can determine each user’s level of access.

Confirmation

RURO software enforces manual review of results that are flagged as positive or abnormal. Appropriate
flags and ranges are determined by the relevant laboratory and can be changed as necessary.

Documentation

Electronic records are securely maintained for patients, tests, accessions, and test results, and RURO’s solutions maintain an audit log for every record in the system.

Authorization

RURO solutions are able to capture and document physician signatures on every authorized test order.
This allows each record to be examined and compared for consistency.

Cloud Storage

RURO offers HIPAA-compliant could storage through our solutions, making records accessible from any location while still maintaining the highest confidentiality standards.


 

Interested In RURO Solutions?

If you think compliance and validation services from RURO are right for your facility, contact us for more information!