Services offered

Project definition

In the project definition phase, the project goal and scope are defined, the key user requirements developed, the main project risks identified, the validation strategy proposed, and the project plan developed.

Project goal

The project goal describes what is expected to be achieved with the project. E.g. move from a paper-based to a paper-less laboratory, or migrate all laboratory agendas and records to an electronic system meeting the data integrity requirements and regulations.

Scope and functionalities

Assessment of modules and functionalities needed to meet the project goal and the customer expectations – key requirements for LIMS, QMS, DMS, LMS, Statistical Data Evaluation, and data integrity.

User Requirements Specification (URS)

User requirements specification (URS) is a basic document created according to customer and/or EffiChem policies and templates. URS specifies the functional, technical, regulatory, security, validation, and documentation requirements of the user on the system. URS is the basis for subsequent validation activities – installation qualification, operational qualification, and performance qualification. Requirements in the URS should be clearly defined and should be structured to provide traceability to the validation tests executed in the validation phase.

Risk Assessment (RA)

Risk assessment (RA) is an exercise aiming to identify risks related to the introduction and implementation of the system. RA usually is developed in cooperation between the customer and the vendor. RA addresses risks that should be covered and mitigated with validation tests and standard operating procedures, resulting in an acceptable level of remaining risk. RA, URS, and Validation Master Plan (VMP) are the primary documents, ensuring a secure performance of the system and compliance with the regulatory requirements and expectations of the authorities.

Validation Master Plan (VMP)

The VMP is a basic validation document that specifies the purpose, methodology, and scope of validation activities, including qualification of infrastructure and validation of the application. VMP describes the validation approach, planning and responsibilities, milestones and timelines, the composition of the validation team, the use of the supplier’s documentation, the structure of validation documentation, and the review and approval process.

Project implementation

The implementation of the project begins with the translation of user requirements to functional, technical, and configuration requirements. This is followed by the corresponding development and testing in the test environment. That is done in an iterative way, resulting in an agreed/frozen final configuration. In addition, a preparation of static and master data is initiated, or a migration/ import from a lower version or supporting databases is arranged.

Configuration workbook

Based on URS, RA, and VMP, EffiChem creates a configuration workbook. This is a document, translating the user requirements into configuration requirements at the level of individual modules, functionalities, and workflows

Freezing of configuration

After the testing of the application in the test environment, the required changes are implemented and the configuration frozen. The frozen configuration is populated in the validation environment and the validation test scripts are executed.

Static and master data

Before going live with the validated application, the system needs to be filled with static data and master data. Static data is supporting modules, including data such as the list of test parameters, list of units, list acceptance criteria, list of customers, etc. Master is pre-filled templates, typically master specifications for samples, enabling the speeding-up of sample logging or other repeatedly occurring operations.

Static data and master data import

To simplify and speed up the static and master data preparation, the process can be replaced or combined with an import of data from excel or other supporting files.

Testing and validation before go-live

Pre-launch software testing and validation is designed to ensure that the application performs as intended and that validation documentation is created for the application in accordance with the requirements of software validation regulations.

GAMP V-Model

EffiChem’s policy is to implement and follow processes that are in line with the GAMP 5 Guide: Compliant GxP Computerized Systems and the V-model described here.

Factory Acceptance Test (FAT)

Factory Acceptance Testing is the process of validating that the developers wrote the code in the way that the customer expects it to function. To complete the FAT, the end user will often visit the vendor to receive a presentation of the software functionality.

Test script

Test script is a document describing a test to be executed in order to demonstrate correct functioning of a software or its part during FAT or installation qualification, operational qualification or performance qualification.

Installation qualification (IQ)

Installation qualification is a process to confirm and document that the application was installed on  sufficient hardware and in an intended environment, all components of the application (installed files) have the correct version, date of origin, and size. All this is adequately documented.

Operational qualification (OQ)

OQ is a process that verifies by means of executed test scripts that the application is working according to requirements specified in the OQ protocol and comply with the defined acceptance criteria. Any deviation from the OQ protocol is documented, the impact is assessed and the deviation is resolved.

Performance qualification (PQ)

PQ is a process to verify and document that the software application is consistently performing to the specifications for its day-to-day use (routine). This is monitored over a certain period when the application is running. Any possible errors or deviations are recorded, assessed and follow up actions determined and implemented.

Validation documentation

EffiChem helps customers and validation teams to develop validation documentation in a way preferred by the client. The documentation can be based on the EffiChem template and best practices, or the customer’s template.


By means of workshops and using the EffiChem URS template, we can help to prepare customer URS, covering regulatory, functional, security, validation, documentation, and technical requirements for the electronic system that becomes a departure point for the project. URS, projects objectives, RA, and VMP establish the definition phase of the project.

Risk analysis

EffiChem helps to develop a risk analysis that enables users to identify, describe, and classify risks, sort them, and guides the team to propose corrective and preventive actions to mitigate the risks from the functional, security, data integrity, and software validation perspective.


EffiChem, together with the client’s team, develops the validation strategy, validation approach, validation team, validation objectives, responsibilities, planning, timelines, validation documentation structure, and reporting.


EffiChem can, in line with the customer requirements, suggest the scope and content of validation protocols and validation reports for IQ, OQ, and PQ.

Traceability matrix

Traceability matrix is a summary document depicting how the URS requirements were reflected in the validation protocols and the corresponding test scripts, and where the results of the tests were reported in the validation reports.

User and admin training

EffiChem offers user, admin and IT training, documented by a EffiChem training certificate.

Key-user training

The training for key users is designed according to the scope of application – LIMS, QMS, DMS, LMS, and Statistical data evaluation

Administrator training

Training for admin functions, including application settings, configuration of roles and users privileges, preparation of static data, and master data.

IT and QA training

IT and QA training, including software validation and data integrity, software life cycle management, maintenance, and coordination of application support.

Maintenance, support and functional enhancements

EffiChem can provide support starting from the preparation of the IT infrastructure, during the entire product life cycle, covering the software installation, qualification, operation and maintenance, incl. tasks related to data security, including backup and restore.

Infrastructure preparation

Depending on the intended application scope and use, EffiChem provides a list of minimal IT requirements for hardware and software, ensuring the application will operate efficiently and securely.


EffiChem coordinates the preparation of the customer’s IT infrastructure with the customer’s IT department, in line with customer policies.

Backup and recovery

EffiChem can help the customer to define the security policies and procedures, including data/system backup and recovery.


Depending on the security policies of the customer, EffiChem can help recommend security measures for software operation on premise or in the cloud.

Functional enhancements

EffiChem helps with the project planning, phasing, and with functional enhancements. All this depends on the size of the organization, size of the implementation team, and resources available.