cromingo e.k., Fusion, Empower, Trainer, empower seminar, training

Standardized Seminars


If you wish a seminar with given topics, then an event from my catalog is the right choice. The seminars are standardized, there is a training documentation and ready-made exercises.

  • Empower™ for Beginners


    The entry-level seminar addresses Empower™ users with little or no prior knowledge. It explains the basics of the software, provides an orientation about the system and shows a basic workflow from the creation of a series of measurements, to the data acquisition and data analysis to the call of a ready-made report. The course offers the opportunity to get to know the basics of the software and to delve into examples. After this course, the user should be able to independently plan measurements, control measuring devices and start measurements, assess completed measurements, create simple evaluation methods and use them for evaluation, and report the results generated using existing report methods.


    topics in detail:


    Structure and structure of the software (projects, user administration, login)


    Function and content of the Empower™ project


    Data recording in the Run Samples window


    Build the Empower™ Review window and create a processing method


    Calibration


    Generation of Result Sets via Background Processing


    Definition of complex sample sets


    Use of view filters


    The course also provides the opportunity to address specific questions and requirements as needed.
    Recommended maximum number of participants: 10
    Prerequisites:

    Basic understanding of chromatography


    Experience with computer systems under Windows


    Price per course (regardless of the number of participants): On request

  • Empower™ for Intermediates


    The advanced seminar requires participation in the entry-level seminar or a comparable level of knowledge. The purpose of the seminar is to show all evaluation options the program for which no additional creation of Custom Fields is required. The settings for the peak integration, quantitative evaluation and system suitability of the Processing Method are discussed in detail and applied. After this course the participant should be able to fully exploit the possibilities of automatic peak integration, to create complex processing methods and to decide for which calculations additional calculation fields have to be created.


    topics in detail:


    Automatic integration via Traditional and Apex Track


    Setting integration events and manual peak integration


    Discussion of the Components, Impurity, Limits, Suitability, Named & Timed Groups and Noise and Drift tabs


    Processing of selected channels


    Reprocessing results after manual post-integration


    Versioning of Results


    The course also provides the opportunity to address specific questions and requirements as needed.

    Recommended maximum number of participants: 10
    Prerequisites:


    Participation in the entry-level seminar or equivalent prior knowledge and some weeks of experience in using the software


    Experience with computer systems under Windows


    Price per course (regardless of the number of participants): On request

  • Empower™ Report Course


    The Report Seminar is aimed at experienced Empower™ users who either want to customize and understand existing reports or want to design their own reports in Empower™. The seminar teaches the full scope of Empower™ report design, giving participants plenty of room to practice themselves in Empower™ reporting.


    topics in detail:


    Presentation of the Preview / Publishers


    Report Method Properties, Individual and Summary Report


    Finding and arranging report objects


    Peak Tables, Chromatogram and Calibration Plots


    Creation of composite groups


    Filter, sort and group report objects


    Hints for Validation of Report Methods


    Recommended maximum number of participants: 8
    Prerequisites:


    Participation in the Advanced Seminar or previous knowledge and already solid experience in using the software


    Experience with computer systems under Windows


    Price per course (regardless of the number of participants): On request

  • Empower™ Custom Field Course


    The Custom Field Seminar is designed for experienced Empower™ users or administrators who want to program their own calculation fields in Empower™ and provides the basic knowledge required to create Custom Fields. Based on practical examples, the topic will be taught and solutions discussed together. Creating Custom Fields requires programming skill. In the course of the course an attempt is made to point out basic approaches.


    topics in detail:


    Managing Custom Fields in in Empower™


    Data and field types


    Definition of input fields


    Simple calculation with Peak and Result Custom Fields


    Logical queries using Bool and Enum fields


    Definition of intersample calculations as a summary and non-summary function


    Hints for Validating Custom Fields


    Recommended maximum number of participants: 6
    Prerequisites:


    Participation in the intermediate course or previous knowledge and already solid experience in using the software


    Experience with computer systems under Windows


    Programming skills


    Price per course (regardless of the number of participants): On request

  • Empower™ for Administrators


    Chromatography skills are not mandatory for the Administrator course. It explains the basics of the software and discusses settings for configuring Empower™. After the course, the participant should be able to understand the setup and configuration of Empower™ and take on administrative responsibilities while operating Empower™.


    topics in detail:


    Definition of system policies


    Create and manage Empower™ projects


    User management (user accounts, groups and roles)


    EEmpower™ Audit Trails


    Basics of setting up measuring instruments and LAC/Es


    Message Center and Monitoring


    Configuration of the electronic signature


    Recommended maximum number of participants: 6
    Prerequisites:


    Experience with computer systems under Windows

    Price per course (regardless of the number of participants): On request

  • Data Review& Audit Trail in Empower™


    This training module is designed for Empower™ users who have a testing function in laboratory management and quality assurance. First, the basic features of the software are presented and the processes outlined from the point of view of the laboratory staff. Subsequently, the procedure for checking data is discussed, the required contents of an audit trail report are presented and the realization of a periodic audit trail review. The course does not require Empower™ prior knowledge.


    topics in detail:


    Foundations of the software


    Empower™ workflow in the laboratory


    Identify results


    Versioning of methods and results, detection of changes


    ID concept in the Empower™ project


    Audit trails in the Empower™ project


    If required: Selection and display of chromatograms and UV spectra


    Recommended maximum number of participants: 10
    Prerequisites:


    Knowledge of the current regulations for data integrity


    Experience with computer systems under Windows


    Price per course (regardless of the number of participants): On request

  • Dioden Array Evaluation in Empower™


    In contrast to conventional single wavelength detection, the analysis of a sample with a PDA/DAD detector provides a 3-dimensional data set as output. These data provide much more information than the 2-dimensional data and can be used, for example, for the 3D display of chromatograms, for determining peak purity (i.e. spectral homogeneity) and for comparing an unknown component spectrum with a reference spectrum to identify a substance. The course also uses practical examples to demonstrate the use of Empower to view and evaluate these data.


    topics in detail:


    Display of 3D data


    Evaluation of 3D data


    Determination of the spectral purity ("peak purity")


    Spectrum Libraries


    Manage Spectrum Libraries


    Reporting of 3D evaluations


    Recommended maximum number of participants: 10
    Prerequisites


    Participation in the intermediate course or previous knowledge and already solid experience in using the software


    Experience with computer systems under Windows


    Programming skills


    Price per course (regardless of the number of participants): On request

Fusion QbD® LC Method Development Training Program


As certified S-Matrix® training partner cromingo® currently offers the following Fusion QbD® training programs:


Fusion QbD LC Method Development

  • Day 1 Topics


    General Software Operation


    Automated DoE Framework


    Supported LC Instruments/Platforms


    Method Development: Part 1 - Chemistry Screening


    Column/Solvent Screening


    Data Exchange Automation Framework


    Export Designs


    Import Results


    Understanding Trend Responses


    Chromatogram Processing for Trend Responses


    Data Analysis


    Best Overall Answer - Numerical Search


    Acceptable Performance Region - Graphical Search

  • Day 2 Topics


    Method Development: Part 2.A - Mean Performance


    Method Optimization - Mean Performance


    Chromatogram Processing for Tracked Peak Results


    Using Peak Tracking Results


    Method Development: Part 2.B - Robustness

    Method Optimizastion - Robustness


    The ReguOpen+Sansry Guidance


    The Meaning of Robustness


    Quantifying Method Robustness


    Final Method - QbD Design Space and PAR (MODR) Reporting

    Defining the Optimum Method


    Defining the Final Design Space


    Defining the Proven Acceptable Ranges (Operating Space)

  • Conditions


    2-Days Onsite-Course


    Recommended Number of Participants: 10


    For Each Participant a Training Laptop is provided


    Price pro course (independent from the number of participants): On request

I would like to discuss your concerns personally with you. Since I am mostly on the road, contact me best by e-mail and give me dates, to which I can reach you by phone.



Participation in the formal training program is highly recommended to learn the best use of the software. In addition, however, further training in the form of workshops or customized training can be arranged as needed. Let us identify your training needs together and take the appropriate measures to qualify your employees.

Made-to-measure Trainings



You think the trainings in my catalog are too general and you need a concept adapted to your processes? Or you need a training on such a very special topic? Maybe just a question-and-answer session across various topics? Gladly I discuss with you your training needs and what implementation options are available.



I would like to discuss your concerns personally with you. Since I am mostly on the road, contact me best by e-mail and give me dates, to which I can reach you by phone.

Qualification and Implementation



By workshops, I understand events that not only qualify your employees, but in which they also actively participate. For example, we can jointly develop a concept for the handling of custom fields or the calculations for specific test methods. The experience gained by your employees should enable them to find their own solutions without support in the future. Workshops are also available to discuss validation concepts.



You want to improve the ability to create peak integration methods? How to define robust automatic integrations and where are the boundaries? How can a manual integration be justified? How can the integration process be understood? When to use which integration algorithm? With chromatograms from your everyday life we can discuss these questions together.



I would like to discuss your concerns personally with you. Since I am mostly on the road, contact me best by e-mail and give me dates, to which I can reach you by phone.

Keyword Data Integrity



In 2016, different drug agencies issued updated darft guidelines on data integrity of computer systems. Inspectors are also becoming increasingly familiar with the Empower ™ software as it is one of the most widely used chromatography data systems in the pharmaceutical sector. Due to the timeliness of the topic, there is an increased demand for support on this topic also for Empower ™. Here I can substantially assist with my background of experience background. You can find the latest versions of the relevant guidelines here:









What does this mean in practical terms?



There is already a wealth of literature covering the topic of data integrity for the chromatography lab in the GxP area. Helpful are the publications of M.E. Newton and R.D. McDowall, who appeared in a series of six articles on ChromatographyOnline in 2018, analyzing and discussing the topic for the different phases of the analytical lifecycle.









Why Empower™ ?



The Empower ™ software is based on a database technology. Apart from the recorded measurement signals, all data is stored in an Oracle database. With this software architecture, the applicable data integrity standards can be implemented in the best possible way..



Empower ™ Data Integrity Functions at a Glance



Database Technology


Each object is uniquely identifiable.


Overwriting of data is not possible.


Clear reference to which data was generated by which methods



Automated Versioning of Results and Methods


complete electronic audit trail


WHO changed WHEN WHAT and WHY.



Assignment of unique Ids


Every object and every result receives a unique identification number.


Uniqueness is given within a project.


Changes to the objects result in the assignment of a new ID.




Questions that we can discuss



What data verification procedure in Empower is recommended?


How can a secure audit of the audit trail be ensured?


Which data should be reported in a report?


How should the roles be defined in Empower?


How can manipulations be revealed?


Which approach to the validation of reports and custom fields is recommended and are there any pragmatic approaches?


and much more....




Configuration



System Policies


audit trail definition


user management


permissions


organization of Empower projects

Operation


defining processes


operation manual


technical and functional support

Custom Fields and Reports


concept for administration and validation


mapping custom field libraries


master templates


design of universally applicable fields and report templates


Talking about Custom Calculations


To map custom calculations in Empower requires a high level of expertise. It's not enough just to work on custom field formulas. You also have to understand which formulas are already present in the Empower software and how the interplay of presets in the Sample Set and settings in the Processing Method work. How can you Use the existing Impurity function sensibly, what settings are required to determine the suitability of the system? Anyone who has ever started to deal with this issue, will quickly realize that there is a lot of literature to sift through this and much will be brought to you only by your own experience. In addition, Empower is not free of errors that, even if reported, must first be learned how to get handled.


Finally, the whole thing must be mapped in a report.


Get someone to help you with this professionally. This saves your resources and you can be sure that your needs have been sustainably translated into Empower.


I not only educate you, I can also take care of the implementation myself or we discuss a concept that enables you to make later adjustments yourself.


The implementation must be done according to GMP specifications? No problem, that's what I'm familiar with!


Just contact me for further questions. Then we can clarify how I can best help you.


getting in contact

Validation of Computerized Systems (CSV)



GAMP 5 describes a validation approach according to the V-model, in which each specification phase is compared to a verification phase. In addition, categories are defined for different software systems But there are usually considerable differences between theory and practice. In most cases, the phases can not be so clearly contrasted or separated. In particular, OQ and PQ often merge in practice into a UAT (User Acceptance Tests) phase. Therefore, it must be ensured that the processes described in the V-Modell interact effectively with each other. Also, systems can not usually be uniformly assigned to a single category, since a computer system usually consists of several hardware and software components that have to be evaluated differently. For a commercially available system with a configuration portion, as is the case with a CDS, the validation phases given below may result.

cromingo e.k., Fusion, Empower, Trainer, V-Modell

cromingo can support, advise or take over all phases with own documents. We can discuss the form of participation together.

  • Planning

    Validation Plan


    Reason and goal of the validation


    Project organization - planning and responsibilities


    Risk management: system selection and supplier evaluation, GxP relevance of the system, classification of the system in a GAMP5 category and determination of the resulting validation measures, functional risk analysis according to FMEA


    Description of the phases of the validation process and control measures during the operational phase


    Determining the deliverables



    User Requirement Specification (URS)


    Phase I: System selection document based on essential requirements for the intended business purpose (Supported Devices, Basic Functions, Regulatory Requirements, Manufacturer Support).


    Phase II: Validation Document: After system selection, knowledge of the system is required (training and own experience with the system, external expertise (manufacturer, independent consultant), detailed analysis of the customer requirements on which the overall validation is based one should pay attention to the fact that one differentiates between requirement and design. The formulation of a requirement should actually be able to be formulated independently of the knowledge of a product. Then this document is also well usable for software upgrades.

  • Specification Phase

    In the specification phase, referring to the list of requirements, it is documented how the requirements in the system are met or implemented in concrete terms, with three different phases:


    Functional Specification (FS)


    For commercially available products, the product specification is the responsibility of the manufacturer and manufacturer documentation should be available. If there is no appropriate documentation because the specifications may consist of many individual documents (multiple software components, no accumulated capture of specifications on successive versions of the software), it may make sense to summarize them in a compact customer document, with reference to the individual documentation.



    Configuration Specification (CS)


    Here you define the configuration of the application required for your business purposes based on your requirements (for example, Audit Trail Settings, Electronic Signature, User Administration, Authorization Concept).



    Design Specification (CS)


    Here you define the design of the technical infrastructure for your system, i.e. computer hardware, software, network, data backup concept, but also authorizations in the network. This phase is ultimately the basis and prescription for installing the system.



    Design Review (DR)


    This phase is completed by a Design Review, in which a list and comparison of all specifications is compiled and reviewed with the project team.



    After completion of these phases, the system should be set up and the test cases developed (valley point in the V model). For the beginning of the test phase, a test plan should be drawn up, which shows the procedure and strategy of the test phase. Measures in the form of test cases, procedures, technical controls or staff training should be established based on a risk analysis taking into account the risk to humans, product and data. Most of the time you will take into account business-related risks. All test cases are already specified in the test plan.

  • Verification Phase

    Installation Qualification (IQ)


    Check whether the technical infrastructure of the system has been set up in accordance with the plan. This phase thus forms the counterpart to the design specification.


    Operational Qualification (OQ)


    Checking the functions of the system. For a category 3 product, manufacturer tests can be incorporated or referenced here. The pure functionality is checked without considering the intended regulatory and business application purpose.


    Note: The manufacturer often offers standardized and automated procedures for the IQ/OQ phase. It is the responsibility of the customer to evaluate and, if necessary, supplement it with appropriate in-house tests to verify the full scope of requirements and specifications. This is done in the next phase, often referred to as Performance Qualification. In the meantime, the term UAT is often used for user acceptance tests, as it is difficult to distinguish between individual phases


    User Acceptance Tests/Performance Qualification (UAT/PQ)


    Implementation / verification of the configuration specification as the first test case Reviewing and / or controlling user requirements through appropriate measures, based on the identified risk to humans, product, data and economic aspects.


  • Conclusion and System Release

    Traceability Matrix (TM)


    Follow-up of all URS points through the specification phase and verification phase. Ensuring that each URS was followed, evaluated, implemented and verified based on the risk rating during the validation process. Indication of measures or controls that have been taken.


    Validation Summary Report (VSR)


    Summary and evaluation of the validation. Compilation of all deliverables. Information on deviations and measures taken in this regard. Indication of follow-up measures. Release of the system for operational use.

External Experience & Expertise



Are you planning for an Empower™ project and you do not want to risk reinventing the wheel? All Empower™ customers ask similar questions. I am happy to lead your project to success with my expertise. I can support your project with expert advice on all Empower™ topics


Definition of user requirements, specifications and risk assessment


Creating test cases


Creating Empower™ report templates and custom calculations


Validation concept for reports and custom fields


User management


Operating SOP


Compliance strategy


Evaluation of device drivers


Rollout training concept and implementation of employee training at all levels


User support and thus ensuring laboratory operation


references to projects already managed