Comprehensive Sample Workflow
CaliberLIMS® achieves the prime objective of total automation of the Sample Workflow, with accountability and authentication by electronic signatures. Registration of Masters (like Tests with complex formulae and evaluation methods)and changes thereto are fully authenticated and version-controlled. Time & Date Stamping facilitates dynamic and copy-controlled generation of Worksheets and COAs.
Trace-ability and accountability, GLP, and Compliance are ensured throughout the sample life cycle. With specially designed Interfaces, Caliber LIMS can also acquire and process external data like that from sophisticated Instruments.CaliberLIMS comes with the following tightly integrated modules and these modules can be configured at any point of implementation.
The Sample Workflow functionality deals with all the activities involved during the life cycle of a sample in the laboratory. For clarity and easy understanding CaliberLIMS treats important activities like Sample Login, Sample Acceptance, Sampling and Sample Allotment, which may involve a set of Tasks and Actions to register and to continue to their logical conclusion, as Database Entities.
The life cycle of a Sample in the Laboratory starts with Sample Login (Registration) and ends with the generation and printing of Certificate of Analysis (COA). The Sample Workflow functionality in CaliberLIMS covers Sample Login, Sample Acceptance, Sampling, Sample Allotment, Test Allotment, Test Results Submission and Approval, COA Printing, and also all the incidental and auxiliary activities like Worksheet Execution, Raw Data Generation, Investigation Routine Performance in case of failed tests, Outsourcing of Samples, Test Trend Analyses, generation of Audit Trails for all important events, etc.
Product Registration facilitates to have product information like generic names, supplier, etc. Specification Registration shall maintain information like, specification number, type such as regulatory, release or can be restricted from use when obsolete. System shall prompt on obsolescence. Test Registration shall facilitate information management like type of test, pass limits, formula, multi formulae for a single set of data and other statistical functions.
Protocol Sheets: Controlled Protocol sheet generation as per the quality system needs can be generated dynamically or an adopted template with dynamic headers and footers. This proves to be very good value addition to the quality systems.
Defined audit trail sequence is maintained and all the changes are preserved for verification with old data, date and time stamp and authority of the person who made the changes. This can be implemented on any desired module. All the committed documents shall bear the date and time stamps of the personnel involved in the change process, shall be recorded,and can be viewed as and when required.
Easy admin tools provide a faster setup of Role and responsibilities to new users and profile setting to the individual user level. Security profile facilitates to set the security level as per the policy defined by the user company. Users and Password management to suite the 21CFR part 11 requirements. Security alerts on important issues and audit trail of all the important Admin activities makes the product secure and robust.