Eight Critical Success Factors to be considered in Times of Organizational Change and Transformation in Regulated Environment (Practical View)


“The Only Thing That Is Constant Is Change” (Heraclitus)

In today’s globalized and fast-changing world, it is very common that life science companies around the globe not only buy and sell entire subsidiaries but also single parts of their operations and business units.

In the highly regulated life science environment, such transactions should be compliant with local and global GxP regulations and in line with IT governance industry standards. For the information technology departments in the regulated life science space, this becomes more and more complex and of growing significance. One of the reasons for this is that IT is becoming an ever more important asset of business operations worldwide. In the life science sector, IT has become a key driver for the success of single products and whole companies. IT supports the daily business and helps regulated CMOs, pharma, medical device and food companies to build validated systems in compliance with health authority regulations and industry standards such as GMP, GLP, GCP, GVP, and FDA 21CFR Part 11 as well as EMA Annex 11.

For the success of a compliant portfolio transformation, the following factors are key:


1. Create an Overall Strategy – Portfolio Transformation Strategy Book

It is good practice to create and implement an overall strategy for a portfolio transformation because the work for such a transformation is not always business as usual. This strategy should provide an overview for which scenario of the transformation to which actions and/or documents are required to keep this transformation compliant and as smooth as possible.

2. Define the Roles and Responsibilities of All Parties Involved

All involved parties shall be aligned, so there is no misunderstanding of who provides what to whom and when. This alignment is also important to deal with upcoming problems proactively and to minimize risks that can occur in such a transformation. This alignment could be done by weekly meetings via telephone or video conferencing and status reports.

3. Alignment Meetings with the Transaction Partner

This is not a fact to underestimate, because it makes work much easier if every transaction partner knows which assets in which condition they will receive from the other party and what work both parties are carrying out.

4. Have a Project Plan in Place

A well organized project plan helps to keep an overview of which information and documents are required. It also helps to keep all parties aligned, such as when they have to complete actions and/or provide items for another action.

5. Provide Specific Templates to the People Who Do the Operational Work

This is very important because normally the templates which are used are not covering a transformation or movement of an asset from one company to another company. Therefore, it is good to provide specific templates for the portfolio transformation to all people who do the operational work to have all required information covered and to have the same format for the documents concerning different program/project parts and tasks like traceability and documentation.

6. Onboarding

People doing the portfolio transformation work shall be on-boarded according to the onboarding procedure of your organization, even if they will later belong to the other company where they will be transferred, before Day-1. After Day-1 new employees working for the divesting part must be onboarded according to the procedure of the new owner of the divested part. But employees who will still work for you in a portfolio transformation shall be on-boarded according to your onboarding procedure.

7. Training

Employees working as part of the team in a portfolio transformation must be got the training to do their role in a transformation as good as possible. This includes normal job role-based training and special portfolio transformation training. Depending on the cooperation of both transaction partners the training should be updated very frequently to reflect the current status and knowledge of transformation actions and deliverables.

8. Coaching

Coaching is as important as it is for a normal organizational change. The only difference is that you have to coach the people doing the transformation work, the people that will leave your organization and the people entering your organization.

We offer personalized services based on your individual needs in the area of transformation and organizational change with a special focus on quality and compliance.

Author: KVALITO Consulting Group


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