CLIA Regulations with Document Control Software

Laboratories must control their business content in accordance with the Clinical Laboratory Improvement Amendments (CLIA). Many labs must also comply with FDA regulations such as 21 CFR Part 11 for maintaining their electronic records. Their commitment to quality is critical to their success since a significant percentage of all medical decisions are based on quality results from clinical laboratories.

Medical laboratory and testing companies may also follow the quality guidelines documented in other government regulations such as:

  • 21 CFR Part 58 (Good Laboratory Practices for Non-Clinical Laboratory Studies)
  • 42 CFR Part 493 (Laboratory Requirements)
  • ISO/IEC 17025:2005 (General Requirements for Competence of Laboratories)
  • ISO 15189:2007 (Medical Laboratories – Requirements for quality and compliance)

Growing laboratory companies that are currently managing their critical content manually or through the use of spreadsheets may be looking for ways to reduce costs, become more efficient, and establish standards while being able to respond to external audits for the Clinical Laboratory Improvement Amendments. These facilities often look for ways to improve the record-keeping of;

  • Performing periodic calibration and preventative maintenance of equipment
  • Maintaining the review and approvals of SOPs and laboratory procedures
  • Making sure personnel is working from the correct version of policies
  • Establishing, updating, and keeping current training records of technicians and laboratory employees
  • Documenting and managing incidents, deviations, and corrective actions

ENSUR offers a centralized platform for laboratory, analytical, and testing companies that automates these document control and quality management tasks.  Using the configurable power of our quality management software, laboratory companies can automate many, if not all, of the functions of a quality program, improving efficiency and eliminating the chance of human error.

Whether you are an established multi-facility laboratory company looking for ways to reduce your costs and improve your record-keeping, or a single growing facility with the stresses of more documents than you can handle manually, ENSUR can help. We’re happy to discuss your requirements and ways to improve your internal documentation processes. Contact us today!