The Good Practice Approach to LIMS Validation

Good practice for the use of computer systems in laboratory applications is now well established and based on many years of experience. The LIMS is simply another modern use of the power and flexibility of computer systems and, therefore, may be approached in a similar manner to other systems utilized within the pharmaceutical industry. Specifically, the LIMS is deemed to he a 

Code of Federal Regulations, Title 21, 211.68 and Part 11 U.S. Code of Federal Regulations, Title 21, Part 58 European Union Directive 91/356/EEC, Annex 11 

Building/facility Facility management Equipment siting 

Equipment design Equipment design Validation life cycle 

Equipment maintenance Equipment maintenance Contracted-out services 

---