Flexible Manufacturing System
Poor performing Manufacturing Documentation leads to quality risk, release delays, higher cycle times and costs. Kneat’s Manufacturing solution is a flexible approach to paperless manufacturing and it helps to address these challenges.
A barrier to more efficient Right First Time manufacturing in the pharmaceutical industry is the use of paper-based documentation processes. Some Life Science companies have goals to become fully paperless, where they fully integrate their manufacturing record with the Process Control System (PCS), the Laboratory Information Management System (LIMS) and the Enterprise Resource Planning System (ERP). While some have achieved this goal for select processes where the benefits clearly justify the very significant expenditure, others are reluctant to introduce such systems on a large scale due to concerns regarding the actual costs, risks, and benefits.
For manufacturing processes that cannot justify a vertically integrated manufacturing execution system, Kneat provides an economical and flexible alternative to becoming a paperless environment, albeit not integrated with the PCS, LIMS or the ERP layers. If you are paper driven right now then Kneat can quickly and economically deliver an end-to-end paperless process for all the production records associated with a batch from dispensing to manufacturing record, sampling, artwork management, packing record, packing inspection, batch audit and release checklists, etc.
• Record each batch (auto assign batch no) in the Batch record logbook complete with all the key batch attributes.
• Based on the master records, quickly generate every record that must be executed in order to successfully disposition the batch. No records will be omitted and they can quickly be released to all those responsible for their execution, e.g. batch history record, packing history record will be released to production etc.
• One time entry of data across all records for the batch. Where data is repeated then it can be auto-populated across many records.
• Execute all records complete with e-signature. In the batch record, production will enter data, attach relevant evidence if requested and sign with their e-signature. Corrections may be made and a full clear audit trail complete with reason for change will be captured.
• Deviations/Exceptions associated with the batch record step can be created seamlessly and routed through workflow as per company procedure.
• Those with correct permissions can see into every record from any device in real time. You can see production operators entering the data.
• e-Batch history record is a part 11 and annex 11 compliant digital record that provides:
• Real time data entry
• Real time access control and traceability for person entering data by time/date sign off and verification (when required)
• Real time information access • real time status information
• Efficient and compliant record review, approval, issue processing & remediation
• After execution, a record can be routed seamlessly for post review and approval.
• Central one click access to every disposition record, ever exception every report, every status greatly speeds up the review cycle.