A preliminary investigation of a pharmaceutical issueDownload PDF
We are experts in quality management and automation in GMP environments
Unique combination of GMP and automation specialists
We specialize in GMP-regulated manufacturing environments.
Our capable and highly experienced GMP consultants provide expert advice on quality management, production and processes within GxP-regulated environments.
Eltronic’s extensive experience with both GMP as well as IT & Automation makes us a preferred supplier of services and solutions within the medical device and pharmaceutical domains.
We offer specialist know-how in the fields of concept development, design and implementation of pharmaceutical production systems.
To learn more: Please read on or contact us
Our Chief GMP Consultants are highly qualified and have a well of experience working with management, QA and production in a GMP environment. We know the challenges that our customers are facing, and we are dedicated to focusing our efforts where they are needed.
By establishing a QMS system from scratch or by using our customer's already existing QMS system as our starting point, we help our customers with all aspects of quality management and GMP compliance and processes.
We work with the following GMP-controlled markets:
- Fill and finish pharmaceutical manufacturing
- API production
To ensure GMP inspection readiness, we deliver services within:
- Leading and strategizing
- Risk and change management
- Outsourced activities and quality agreements
- Project planning and execution
- QP/QA/QC services and clean-up projects
- Audits and inspections
- Training and coaching
- Operation excellence
Getting your pharmaceutical optimization started
Could your GMP setup benefit from a gap analysis, is your production in need of an inspection or would your flow of documents profit from an impartial assessment?
The extent of pharmaceutical issues can be difficult to grasp, making the estimation of a project impossible. Shedding extra light on the issue before turning it into a project is beneficial as it eliminates many unknowns. A potential project will thereby become more focused, saving you time and resources.
At Eltronic Pharma Engineering, we assist you in assesing the rootcause and extent of your issue with our one-day workshop.
We have a holistic and pragmatic approach
We are GMP experts
Our team includes specialists with extensive experience within QA, production and production technology in quality-controlled environments.
We identify gaps and improvement areas
Based on real work experience with GMP compliance and QMS systems, we are able to quickly identify gaps and areas of improvement.
We consider all aspects
We always consider all aspects of a process or production to ensure optimized and integrated solutions.
We have many years of management experience
Our Chief GMP consultants have many years of management experience and are able to offer qualified advice on quality management control and strategies.
We are pragmatists
We ensure that you meet the exact requirements in order to maintain GMP compliance for your specific business area.
We simplify the complex
We always aim at making things simple and eliminating all redundant processes.
IT & Automation solutions designed for pharma and devices
Eltronic is one of the largest automation companies in Denmark. Our IT & Automation department includes more than 75 highly specialized and experienced engineers and technicians.
Our services range from electrical hardware and PLC to HMI, SCADA, intelligent 2D- and 3D-vision systems for robots, serialization, MES and database solutions as well as configuration of software connecting the technical solutions.
A group of our automation specialists have thorough experience designing and implementing automation solutions complying with GAMP V.
Read more about our automation services here.
QMS is in our DNA
Quality Management Systems
- Designing and building new QMS systems
- Adjusting existing QMS systems to ensure adequate GMP compliance
- Support for processes, projects, production etc.
- Temporary stand-in consultants in production or QA
Gap and verification services
- Due diligence
- Inspection mock-up and support
Capability building and training
- CAPA and deviation training
- Seminars in GMP (Good Documentation Practice)
- CR cases - do's and don'ts
- Real time batch release and NCs