Services offered

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.

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) 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) 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.

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.

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 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 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 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.

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.

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.

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

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

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