Page 47 - Creative Ebook
P. 47

OpenText Electronic Lab Notebook for Content Suite by KineMatik



 Use Case


                                                                                                                                                                                                                                       Life Sciences





               Company: Global Diagnostics Company




               Location:  US





               State of Play





               • The capturing and searching of research data was

                    manual and therefore slow and prone to error


               • Poor collaboration between departments such as Quality

                    and Production and sites. There was no way to reuse

                    data



               • Regulatory compliance was difficult to maintain and it

                    was difficult to comply with Intellectual Property best

                    practices


               Requirements
                                                                                                                                      Impact/Value



               • Needed an automated system to capture and find

                    research data faster                                                                                              • Organization configured workflows to meet regulatory (e.g. 21

                                                                                                                                           CFR Part 11) requirements
               • Wanted to be able to share data between multiple


                    research projects, departments and sites                                                                          • Regulated environment compliance


               • Needed a system to help protect Intellectual Property                                                                • Search capabilities mean time and money savings

                    and assist with Compliance                                                                                        • Historical record of all research related activities and a full



               • Needed to ensure that regulatory audits were efficiently                                                                  audit trail which helped to maintain regulatory compliance
                    carried out                                                                                                       • Integration to other systems, e.g. calibration database



               • Support a user community of both staff and contractors

                    in a global multidisciplinary manner




                                                                                                                                                                                                                                                47
   42   43   44   45   46   47   48   49   50   51   52