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Efficient IT for regulated companies

Is your IT adaptable and efficient enough?
Is your IT adaptable and efficient enough?

Rising cost pressure and increasing statutory requirements particularly in the life sciences industry mean that fast, efficient IT systems are a necessity, along with cleanly defined, streamlined workflows rigorously implemented in their management.

Your situation/motivation

Do these statements apply on a general basis?

  • Corporate IT systems are expensive and very complex!
  • IT must be available everywhere but should not be expensive!
  • Competitors, innovations and market changes force companies to invest in ITand to install streamlined, efficient processes!

What is «efficient IT»?
«Efficient IT» reconciles different perspectives of the IT system:

  • The company as user
  • IT as a service provider Ecology («green IT»)
  • Costs

Efficient IT interacts differently with each of these individual players.


The company's perspective
From the company's perspective, IT should primarily be geared to the future. Particularly important aspects are as follows:

Unlimited growth
In times of growth, IT should never be the bottleneck or even block growth because systems cannot be extended or cannot be configured for new requirements.

When IT systems face new requirements, it should be possible to quickly and efficiently adapt the IT systems exactly
to these requirements.

Security and availability
In times of constant availability, IT should permit precisely this. Data is available everywhere and at all times. However, this trend does involve a risk. Not only does data security now need to be guaranteed solely in the company's own rietwork, but you need to enable this for topics like cloud, lndustry 4.0, Mobile Computing and BIG DATA. Topics, which are currently very important in data security discussions. The focus is always on protecting one's own data against unauthorised access. The data-security aspect in relation to secure archiving and protection against data loss plays a particularly important role, specifically in the regulated sector.

Of course, it is in the company's interests if the IT system can perform more tasks for the company with a lower budget and less staff etc. in line with the phrase «efficiency = do more with less». At the same time, IT should be able to make resources available whent hey are needed. Conversely, this means plana­bility from the company 's perspective. IT resources are provided when and only when required. However, should a shortage of resources occur, it is the supreme aim to keep downtime as short as possible.


The perspective of IT as a service provider
The company's main demands on IT systems mean that IT must focus on topics such as structure, quality and ecology in particular.


  • Minimising system complexity
  • Modulisation of system components
  • Categorising and standardising the IT environment
  • Outsourcing IT services which do not have direct contact with the customer


  • Proactive and not reactive
  • Focus on service orientation and uality of service
  • Standardisation of software tools Integration and consolidation of new topics

Regulated sector

  • EU GMP Annex 11/15 and/or 21 CFR Part 11 Compliance of the systems and their lnfrastructure
  • Change management
  • Risk management
  • Compliance with the life-cycle princi­ples and the documents evidence axiom in regulated industries
  • Compliance with the IT governance regulations within the framework of company directives

What does this mean for IT management in a validated environment? lt means that the IT system must greatly standardise and tackle its tasks in process-orientated and risk-orientated manner.

The ecological perspective
Society's changed view in respect of natural resources and dealing with the environment leads to the requirement that IT systems have to be «green»:

  • Reduce energy consumption
  • Optimised ITservice processes for short reaction times
  • Optimum use of resources
  • Using state-of-the-art technology in day-to-day business
  • Avoiding electronic waste and using appropriately certified products


The cost perspective
IT is frequently viewed purely as a cost factor as already described in the company's perspective. However, if the aspects of ecology, efficiency, reliability and quality of service are implemented correctly, this also leads to cost-efficient usage of IT resources. lf the aspects of growth, adaptability, security and availability are implemented in a clear and systematised structure (allowing for he risk-based CSV approach in accordance with GAMP5), this turns IT as a  cost factor into IT as a benefit factor and business enabler. « Do more with less» is then a motto which is practised in the IT department.


What we offer and benefits you Analysis
Basic Audit
We offer a practically orientated GAP analysis of your IT situation allowing for GAMP 5 and 21 CFR Part 11 in order to determine the potentials for boosting efficienca.

You get to know your company and its IT status from an external point of view and uncover your strengths and weaknesses by yourself.

Management Consultancy
We offer to you strategic advice on setting up your IT strategy, your IT organisation, your IT workflows and cost estimations and deadlines.

Start-up assistance
You overcome the initial obstacles, familiarise yourself with our modes of operation and immediately initiate the required follow-up activities.

Tactica support
Let us shoulder management activities and persuasion effort! We monitor work progress and initiate only the steps required.

System consultancy
Together with you, we elaborate the implementation schedules, required documentation and procedures. We guide and assist your IT team in project work.

Time  = bottleneck
Practical work
We implement requirements, elaborate documents (e.g. SOPs), implement modes of operation, check them and release them together with you.

External Pressure
Taking the load off of your business departments
Save your own resources and invest only as much as absolutely necessary by using us for the day-to-day project work.


Efficient IT - the route to improvement
Phase 1: How do I achieve these goals?

1. Goal definition      
2. Fit-Gap analysis
3. SWOT analysis
4. ldentifying projects and actions
5. Plan - Do - Check - Act: initiating and implementing projects
6. Progress chasing
7. Ongoing monitoring and ongoing improvement

Phase 2: How do I  implement what has been planned?

1. Eperienced consultants and former IT managers for

  • analysis
  • action planning and implementation
  • project management
  • progress chasing
2. Interim IT managers/CIOs
3. Coaches for IT management.


Dr. Thomas Karlewski| Managing Consultant Efficient IT|Chemgineering|The Business Designers






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