Basic Information

Abstract Number: 1520-5     Author Name: Kevin Rawls Affiliation: PerkinElmer Session Title: Laboratory Management Event Type: Oral Event Title: Robust Reporting Tools in a Controlled Environment Presider(s): Barber, William Start Time: 03:05 PM ( Slot # 6 ) Date: Tuesday, March 10th, 2009 Location: S505b Keywords: Laboratory Automation, Laboratory Informatics, LIMS, Quality

Abstract Content

Laboratories today need the ability to show compliance with a number of regulatory agencies from the local to federal governing levels. There is also the challenge of meeting strict document control regulations in order to keep company certifications (ISO, 21 CFR, etc.) current. Controlling the circulation of various documentation (including LIMS production reports) is vital in an environment where any unauthorized paperwork could cause a serious problem. In a controlled environment where there are mandatory document control procedures, you must define: • How you approve system output / documents • How you update or re-approve amended output / documents • How you identify changes • How you ensure the RIGHT people are involved in the RIGHT approval process before something is used in production • How you control report formats or documents of external origin • How you prevent the inadvertent usage of obsolete report formats How do laboratories accomplish this feat? LABWORKS™ LIMS 6.0, from PerkinElmer provides the report management capabilities needed to achieve compliance in these controlled environments. It offers the Workflow Architect and Object Publisher to facilitate required compliance with these agencies. This presentation will detail the process and results achieved by using these applications.