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.
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.
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
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.
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
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.
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
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.
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
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™.
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
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.
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
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.
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
As certified S-Matrix® training partner cromingo® currently offers the following Fusion QbD® training programs:
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
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)
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.
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.
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.
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:
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.
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..
Each object is uniquely identifiable.
Overwriting of data is not possible.
Clear reference to which data was generated by which methods
complete electronic audit trail
WHO changed WHEN WHAT and WHY.
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.
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....
audit trail definition
user management
permissions
organization of Empower projects
defining processes
operation manual
technical and functional support
concept for administration and validation
mapping custom field libraries
master templates
design of universally applicable fields and report templates
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.
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 can support, advise or take over all phases with own documents. We can discuss the form of participation together.
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
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.
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:
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.
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).
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.
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.
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.
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
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.
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.
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.
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