Accreditation Body Assessment of LIMS
Laboratory Informatics
Oral Presentation
Prepared by M. Sica1, M. Ross2
1 - ANSI National Accreditation Board, 11617 Coldwater Rd., Suite 101, Fort Wayne, IN, 46845, United States
2 - ANSI National Accreditation Board, 500 Montgomery Street, Suite 625, Alexandria, VA, 22314, United States
Contact Information: msica@anab.org; 414-501-5356
ABSTRACT
Assembling, organizing and controlling` data that is generated by laboratories can be challenging. As the national and international standards for laboratories advance, so does the need for improved quality laboratory information management systems (LIMS). Systems that were efficient and effective 10 years ago, may no longer meet the demanding national and international accreditation standards.
Laboratories are required to manage and maintain procedures that accurately reflect all phases of current laboratory activities such as assessing data integrity, taking corrective actions, handling customer complaints, test methods, and managing all documents pertaining to quality. This can all be accomplished by the use of a LIMS.
In addition, all contact with clients, including contract review documentation, can be recorded and kept with the project documentation for access by the staff performing the work. A LIMS can provide extensive options for tracking and maintaining all correspondence, such as the ability to attach electronic files.
This presentation can help a laboratory to determine if a laboratory’s current LIMS meets accreditation standard requirement, including those standard specific requirements to LIMs. These requirements include protection from unauthorized access, safeguarding data, maintaining data integrity as well as recording of system failures.
Laboratory Informatics
Oral Presentation
Prepared by M. Sica1, M. Ross2
1 - ANSI National Accreditation Board, 11617 Coldwater Rd., Suite 101, Fort Wayne, IN, 46845, United States
2 - ANSI National Accreditation Board, 500 Montgomery Street, Suite 625, Alexandria, VA, 22314, United States
Contact Information: msica@anab.org; 414-501-5356
ABSTRACT
Assembling, organizing and controlling` data that is generated by laboratories can be challenging. As the national and international standards for laboratories advance, so does the need for improved quality laboratory information management systems (LIMS). Systems that were efficient and effective 10 years ago, may no longer meet the demanding national and international accreditation standards.
Laboratories are required to manage and maintain procedures that accurately reflect all phases of current laboratory activities such as assessing data integrity, taking corrective actions, handling customer complaints, test methods, and managing all documents pertaining to quality. This can all be accomplished by the use of a LIMS.
In addition, all contact with clients, including contract review documentation, can be recorded and kept with the project documentation for access by the staff performing the work. A LIMS can provide extensive options for tracking and maintaining all correspondence, such as the ability to attach electronic files.
This presentation can help a laboratory to determine if a laboratory’s current LIMS meets accreditation standard requirement, including those standard specific requirements to LIMs. These requirements include protection from unauthorized access, safeguarding data, maintaining data integrity as well as recording of system failures.
