Laboratory Compliance Risk Assessment Guide
Having confidence in the quality, reliability, and integrity of laboratory data and reported results is a requirement for all analytical laboratories across all industries. The fundamental business need to satisfy both data integrity and regulatory requirements appropriate to the decisions made on the results is essential for continued operation.
Balancing essential standards of compliance with appropriate cost effectiveness is challenging to get right. To help laboratories understand potential laboratory compliance risks, Agilent has developed two risk evaluation tools:
This tool is focused on regulated laboratories that align their quality policies and workflow with pharmaceutical and biopharmaceutical requirements. Typically, these laboratories are audited by pharmaceutical regulators such as the FDA or members of PIC/S.
If your laboratory is audited by regulatory authorities such as this – select this GxP Risk Tool and follow the instructions to evaluate your potential compliance risks.
This tool was written to support laboratories in the food, chemical and energy, forensics, environmental, and contract testing laboratories to provide relevant proof of system verification — especially those that may be working under ISO 17025 or similar quality management conditions
If the work of your laboratory is closer to this description, select this Instrument Verification Tool and follow the instructions.
FDA, members of PIC/S, and other regulatory bodies are still identifying fundamental compliance and data integrity findings during audits and inspections, promoting a continued focus on these subjects. This has globally elevated the profile of laboratory compliance in pharma, biopharma, and other GxP-regulated industries.
Laboratories in many regulated industries must find a way of balancing continued efficient operation with identifying areas of potential high risk that need to be addressed to minimize potential regulatory findings.
Agilent developed this GxP Risk Tool to help GxP regulated laboratories evaluate and better understand and identify potential aspects compliance risk exposure for analytical instruments, laboratory software, or aspects of laboratory audit preparation for regulated labs.
There are three different components of this GxP Risk Tool, focusing on instruments, software, and audit readiness. Please select one or more of the three risk areas to evaluate your risk profile.
For each risk area of interest, read and answer ALL the questions in that section. Then click “Submit”.
Risk assessment is well established for GxP compliant laboratories, but the principles apply to all laboratories, particularly data integrity and the scientific validity of the analysis. For laboratories in the food, chemical and energy, forensics, environmental, and contract testing laboratories, many may work to ISO 17025 or similar quality standards/management conditions.
The detailed structure of quality systems based on satisfying ISO clauses can leave laboratories unsure and unaware of the potential scientific risks associated with the analysis. This Instrument Verification Tool was developed to help laboratories identify areas of higher risk associated with verification of instrument performance.
For verification-related risks, read and answer ALL the questions in that section. Then click “Submit”.