EffiValidation 3.0 software basic training module

Transcription

1 EffiValidation 3.0 software basic training module Oct 3,

2 Agenda EffiChem company EffiValidation 3.0 software : overview International standards and guidelines Software features Structure Modules and algorithms Compliance Laboratory workflow and sw EffiValidation Training examples DEMO Any real data available?

3 EffiChem Company Started in 1999; more than 450 customers, 1050 users, 34 countries Our aim is to anticipate and solve issues, mitigate risks and to avoid deficiencies in laboratory quality We develop and supply statistical software for regulated analytical laboratories: Accredited according to the ISO/IEC standard (testing and calibration laboratories) Quality control laboratories in life science and other industries Main products/services: software EffiValidation, documentation, validation services, training

4 Software EffiValidation 3.0: Overview Software 7 modules: method validation, uncertainties, calibration, control charts, interlaboratory studies, software validation, electronic laboratory logbooks Setup: Stand-alone, Client-server or Terminal-server (one database to store data from all users) Access control: ensured using a User name and Password Compliance: fully validated, compliant with 21 CFR Part 11 (Full audit trial)

5 International Standards and Guidelines ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories general requirements that a laboratory has to meet if it is to be recognized as competent to carry out tests and/or calibrations, including sampling. Chapter 4: Management requirements 4.3 Document control MODULE electronic record books Chapter 5: Technical requirements 5.4 Test and calibration methods and method validation method validation, uncertainties 5.5 Equipment electronic record books 5.6 Measurement traceability electronic record books 5.7 Sampling electronic record books 5.8 Handling of tests and calibration items electronic record books 5.9 Assuring the quality of test and calibration results. control charts, inter-laboratory comparison 5.10 Reporting of results electronic record books, uncertainties, software validation

6 International Standards and Guidelines ISO/IEC 17025: chapter Validation of methods Validation is the confirmation by examination and the provision of effective evidence that the particular requirements for a specific intended use are fulfilled The laboratory shall validate non-standardized methods, laboratory designed/developed methods, standard methods used outside their intended scope, and amplifications and modifications of standard methods to confirm that the methods are fit for the intended use. Validation shall be as extensive as is necessary to meet the need of the given application or field of application. The laboratory shall record the results obtained, the procedure used for the validation, and a statement as to whether the method is fit for the intended use The range and accuracy of the values obtained from validated methods (e.g. uncertainty of the results, detection limit, selectivity of the method, linearity, limit of repeatability and or reproducibility, robustness against external influences and/or cross sensitivity against reference from the matrix of the sample/test object) as assessed for the intended use shall be relevant to the customers needs

7 International Standards and Guidelines ISO/IEC 17025: chapter Estimation of uncertainty of measurements Testing laboratories shall have and shall apply procedures for estimating uncertainty of measurement. In certain cases the nature of the test method may preclude rigorous, metrologically and statistically valid, calculation of uncertainty of measurement. In these cases the laboratory shall at least attempt to identify all the components of uncertainty and make a reasonable estimation, and shall ensure that the form of reporting of the result does not give a wrong impression of the uncertainty. Reasonable estimation shall be based on knowledge of the performance of the method and on the measurement scope and shall make use of, for example, previous experience and validation data.

8 International Standards and Guidelines ICH Q2 (R1): VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY The guideline presents a discussion of the characteristics for consideration during the validation of the analytical procedures The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. For details, see ICH Q2 (R1) Note: ICH = INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

9 Software Features Structure Database structure - Firebird or Oracle database All data stored at one location, well secured (backup and restore function) Basic structural element: an analytical method being validated, uncertainties estimated, control chart constructed, calibration model developed, etc.

10 Software Features Modules and algorithms method validation, uncertainties, calibration, control charts, inter-laboratory studies, software validation, electronic laboratory logbooks

11 Software Features Modules and Algorithms

12 Software Features Compliance ISO in chapter states: the commercial software (e.g. wordprocessing, database and statistical programmes) in general use within their designed application range may be considered to be sufficiently validated. For EffiValidation software development and validation, the V-model strategy was used. Full software validation and compliance with 21 CRF Part 11 (electronic records and signatures) is guaranteed.

13 Software features Compliance Software validation 21 CRF Part 11

14 Laboratory workflow and sw EffiValidation 3.0 Sampling, Handling, Transport and Storage Sampling plan Sampling documentation Sample identification Sample protection and integrity Transport conditions Storage conditions Testing Controlled environment. conditions Written procedures Qualification of personnel and material Equipment calibration and maintenance 5.5 and 5.6 Method validation, Reporting including uncertainty Test conditions Test results Estimated uncertainty, Traceability Control of nonconform. results Maintenance of records Record integrity Data security

15 Business advantages Continuous improvement of quality and laboratory effectiveness Better on-line overview of laboratory quality Improved effectives due to automatically generated validation and uncertainty reports, control charts, etc. Increased reputation to attract more customers and generate more contracts for testing and calibration services. Reliable test results including their uncertainties Inter-laboratory comparison Compliance with the most stringent requirements, enabling to defend laboratory results against any customer requirements, and regulatory or legal bodies

16 Training Objectives Gaining theoretical know-how Practicing DEMO and real examples Meeting ISO compliance training requirements Additional training objectives and expectations to be specified by the customer:

17 Conclusions and Action Points during Wrap-up Customer wishes (nice-to-have) Issues to be resolved or completed Evaluation of the training objectives EffiChem certified users