ecoSPECS supports companies in optimizing and complying with their processes and quality standards according to the applicable guidelines and standards.
UNLEASHING
EFFICIENCY +
ENSURING
COMPLIANCE
UNLEASHING
EFFICIENCY +
ENSURING
COMPLIANCE
ecoSPECS supports companies in optimizing and complying with their processes and quality standards according to the applicable guidelines and standards.
AN OVERVIEW OF OUR SPECTRUM
Our focus is on regulatory quality management, which includes the planning, implementation and and monitoring of quality standards and compliance with GxP requirements. In addition to this, we take on the coordination of technical trades and project management.
We offer customized solutions and focus on continuous training to ensure sustainable success.
AN OVERVIEW OF OUR SPECTRUM
Our focus is on regulatory quality management, which includes the planning, implementation and and monitoring of quality standards and compliance with GxP requirements. In addition to this, we take on the coordination of technical trades and project management.
We offer customized solutions and focus on continuous training to ensure sustainable success.
Q
QUALIFICATION
We test and qualify the conformity of production facilities, rooms air technology systems, and clean media so that they fulfill the relevant requirements and specifications. We also accompany the regular inspections and updates during ongoing operations.
_ Design phase: SMFSite Master File, VMPValidation Master Plan, FSFunctional Specification, DSDesign Specification, HDS+SDSHardware Design Specification
+ Software Design Specification, RARisk Assessment, VAPValidation plan
_ Test phase: SATSite Acceptance Test, FATFactory Acceptance Test, DQDesign Qualification, IQInstallation Qualification, OQOperational Qualification, PQPerformance Qualification
_ Final phase: VSRValidation Summary Report, RTMRequirement Traceability Matrix
_ Periodic tests: PRPeriodic Review, RQRequalification
E
ENGINEERING
ecoSPECS Engineering is a partner for plant managers and engineers in the life science sector and offers GxP-compliant realization of your projects. Our range of services in the field of piping-based energy and media supply systems includes technical building equipment and laboratory equipment.
_ Work safety
_ Project planning and control
_ Project management
_ Construction owner representation
_ Software-supported planning
_ Energy and media data analyses (balance sheets, determination of characteristic values, efficiency analysis)
_ Monitoring concepts for water media (e.g. in accordance with TrinkwV, 42nd BImSchV)
T
TRAINING
Our training courses are aimed at improving or expanding the knowledge, skills, and competences of your team. Continuous development and customization of our training is a high priority for us.
We create training materials that are customized to your company and meet the latest standards.
_ GxP basic training
_ Topic-specific training courses
_ Customised training courses
V
VALIDATION
Validation is the systematic process of ensuring that a system or process fulfills the specified requirements and its function consistently and reliably. Validation ensures compliance with standards and regulations, including transport, cleaning, computer software as well as data integrity.
_ Design phase: VMPValidation Master Plan, URSUser Requirement Specification, RARisk Assessment, VAPValidation plan
_ Test phase: IQInstallation Qualification, OQOperational Qualification, PQPerformance Qualification
_ Final phase: VSRValidation Summary Report, RTMRequirement Traceability Matrix
_ Periodic tests: PRPeriodic Review, RQRequalification
C
COMPLIANCE
Implies compliance with laws, regulations, standards, and internal guidelines. This includes internal controls and processes to minimize potential risks and ensure integrity and reliability. Implementation of internal controls and processes to minimize potential risks and ensure integrity and reliability.
Accompanied by the qualification and validation process, this ensures that internal processes comply with processes and standards and are implemented effectively.
_ Definition of requirement profiles
_ Definition of requirement and functional specifications
_ Creation of risk analyses (FMEAFailure Mode and Effects Analysis)
_ Process optimization
_ Quality control
_ Regulatory support and advice
_ Project management
_ GxP consulting
_ Preparation, support, and implementation of audits
_ Quality assurance
_ Change management (deviations, CAPACorrective and Preventive Actions)
_ Preparation and processing of regulations (SOPStandard Operating Procedure)
P
PROJECT MANAGEMENT
We take on the management of major projects in the industrial/laboratory/production sector, project management of major projects, engineering in the construction and technical trades and represent the client. In addition, we offer consulting and the determination of optimization measures for major projects.
_ Scheduling
_ Cost management
_ Contract management
_ Procurement management/claims management
_ Construction Management
_ Commissioning management
_ Management of qualification
_ Organization of acceptance and handover to company
TOGETHER
WE ARE
AWESOME.
E
ENGINEERING
ecoSPECS Engineering is a partner for plant managers and engineers in the life science sector and offers GxP-compliant realization of your projects. Our range of services in the field of piping-based energy and media supply systems includes technical building equipment and laboratory equipment.
_ Work safety
_ Project planning and control
_ Project management
_ Construction owner representation
_ Software-supported planning
_ Energy and media data analyses (balance sheets, determination of characteristic values, efficiency analysis)
_ Monitoring concepts for water media (e.g. in accordance with TrinkwV, 42nd BImSchV)
TOGETHER
WE ARE
AWESOME.
T
TRAINING
Our training courses are aimed at improving or expanding the knowledge, skills, and competences of your team. Continuous development and customization of our training is a high priority for us.
We create training materials that are customized to your company and meet the latest standards.
_ GxP basic training
_ Topic-specific training courses
_ Customised training courses
Q
QUALIFICATION
We test and qualify the conformity of production facilities, rooms air technology systems, and clean media so that they fulfill the relevant requirements and specifications. We also accompany the regular inspections and updates during ongoing operations.
_ Design phase: SMFSite Master File, VMPValidation Master Plan, FSFunctional Specification, DSDesign Specification, HDS+SDSHardware Design Specification + Software Design Specification, RARisk Assessment, VAPValidation plan
_ Test phase: SATSite Acceptance Test, FATFactory Acceptance Test, DQDesign Qualification, IQInstallation Qualification, OQOperational Qualification, PQPerformance Qualification
_ Final phase: VSRValidation Summary Report, RTMRequirement Traceability Matrix
_ Periodic tests: PRPeriodic Review, RQRequalification
V
VALIDATION
Validation is the systematic process of ensuring that a system or process fulfills the specified requirements and its function consistently and reliably. Validation ensures compliance with standards and regulations, including transport, cleaning, computer software as well as data integrity.
_ Design phase: VMPValidation Master Plan, URSUser Requirement Specification, RARisk Assessment, VAPValidation plan
_ Test phase: IQInstallation Qualification, OQOperational Qualification, PQPerformance Qualification
_ Final phase: VSRValidation Summary Report, RTMRequirement Traceability Matrix
_ Periodic tests: PRPeriodic Review, RQRequalification
C
COMPLIANCE
Implies compliance with laws, regulations, standards, and internal guidelines. This includes internal controls and processes to minimize potential risks and ensure integrity and reliability. Implementation of internal controls and processes to minimize potential risks and ensure integrity and reliability.
Accompanied by the qualification and validation process, this ensures that internal processes comply with processes and standards and are implemented effectively.
_ Definition of requirement profiles
_ Definition of requirement and functional specifications
_ Creation of risk analyses (FMEAFailure Mode and Effects Analysis)
_ Process optimization
_ Quality control
_ Regulatory support and advice
_ Project management
_ GxP consulting
_ Preparation, support, and implementation of audits
_ Quality assurance
_ Change management (deviations, CAPACorrective and Preventive Actions)
_ Preparation and processing of regulations (SOPStandard Operating Procedure)
P
PROJECT MANAGEMENT
We take on the management of major projects in the industrial/laboratory/production sector, project management of major projects, engineering in the construction and technical trades and represent the client. In addition, we offer consulting and the determination of optimization measures for major projects.
_ Scheduling
_ Cost management
_ Contract management
_ Procurement management/claims management
_ Construction Management
_ Commissioning management
_ Management of qualification
_ Organization of acceptance and handover to company
E
ENGINEERING
ecoSPECS Engineering is a partner for plant managers and engineers in the life science sector and offers GxP-compliant realization of your projects. Our range of services in the field of piping-based energy and media supply systems includes technical building equipment and laboratory equipment.
_ Work safety
_ Project planning and control
_ Project management
_ Construction owner representation
_ Software-supported planning
_ Energy and media data analyses (balance sheets, determination of characteristic values, efficiency analysis)
_ Monitoring concepts for water media (e.g. in accordance with TrinkwV, 42nd BImSchV)
T
TRAINING
Our training courses are aimed at improving or expanding the knowledge, skills, and competences of your team. Continuous development and customization of our training is a high priority for us.
We create training materials that are customized to your company and meet the latest standards.
_ GxP basic training
_ Topic-specific training courses
_ Customised training courses
COLLAB?
Wir freuen uns auf Ihre Anfrage
We are looking forward to your inquiry and will get back as soon as possible.