Compliance

Audit Security, Traceability, Integrity, CLIA, HIPAA Compliant

QMSQC understands how critical quality assurance and compliance information are to you, and offers included full auditing with training, and optional compliance management support to ensure that corrective and preventive actions are identified and performed quickly and efficiently. We provide direction to ensure quality systems are in full compliance with the regulations.  QMSQC helps laboratories meet federal and state regulatory and compliance measures with formal policies, systems, and procedures to assure quality test results are within acceptable limits of accuracy and precision.  

Methods, procedures, management of each analytical procedure, purpose of each test, standards, and assessment of test results with applicable quality procedures ensure accountability of data that maintains confidentiality and practice to the highest ethical standards. The validity and reliability of lab data are maximized by the ease of adherence QMSQC offers to allow QC procedures and QMS protocols based upon principles of data quality indicators to be used that end up as good laboratory practices (GLP).

QMSQC can audit for compliance and to stay compliant throughout the process, ensures compliance at minimum, 21 CFR Part 11, and provides audit trails, secure recordkeeping, maintains full Chain of Custody procedures and audit records for Internal, external audits, and Management reviews.  All necessary patient and Quality Control documentation is maintained within the program and Patient and Quality Control reports are available at any time to meet inspection needs.  HIPAA regulations regarding privacy are easy to implement. Passwords and Access levels can be defined for each user.   QMSQC features a comprehensive audit trail system to properly comply with the FDA 21 CFR Part 11 and the EU Annex 11 guidelines. By having all the audit information available centrally, it is possible to greatly reduce the time for audit prep.

QMSQC allows for archiving of data from the system for the purpose of maintaining system performance and to ensure that backup windows can be maintained over time. This allows configuration of how often to archive data and the rue for what data should be archived. QMSQC allows viewing and reporting of archived data.