In yesterday's webcast "Dissecting ERP and CRM Vendors for Cost Effective Validation" we discussed what regulated companies
should be looking for when selecting ERP or CRM software and system integrators
in the Life Sciences industry.
Specifically, we looked at how the choice of software vendor
and system integrator affects the validation of the system, in terms of:
- Cost effective and efficient validation,
- Level of compliance achieved, both in terms of compliant business processes and compliant validation,
- The quality of the final solution delivered.
We also reviewed what regulated companies can do to ensure
that projects obtain the right balance between project cost, timescales and
quality.
Unfortunately we ran out of time to answers all of the
questions submitted during the webcast and our apologies to the person whose
question we didn't have time to get around to. As promised, here is our answers
to your question.
Q. How current is your data on cost, time, and quality?
A. In the webcast we showed a slide that inferred that time
and cost considerations are usually completely divorced from
quality/validation, where of course they should be balanced. Our experience is
that a small number of Life Sciences companies (mainly larger pharmaceuticals)
have invested significantly in adopting GAMP 5 risk-based validation and have
developed flexible SDLCs which can accommodate ERP/CRM implementation in a cost
effective and efficient manner.
However, this is still a small minority and as the later
vote showed, most companies are still struggling to achieve the proper balance
between time, cost and quality.
We also mentioned that it is possible to reduce the cost of
validation to around 2-3% of the overall project budget, but most projects are
still around 10-15%. The 2-3% figure assumes a well-defined SDLC that is
specific to the ERP/CRM system being validated and also a great deal of process
repeatability. In the case of Business & Decision, we can achieve those
figures because (a) with due modesty, we are experts in implementing ERP/CRM
and are also experts in risk-based validation and (b) we have done this dozens
and dozens of times before in Life Sciences.
Some large pharmaceutical companies are also quoting similar
single digit figures for the cost of validation, but the reality is that they
are being selective in the figures they are quoting i.e. they represent mature
processes for validating the roll-out of new phases of an existing system,
using a system specific, mature and well-understood SDLC.
For most companies implementing ERP or CRM for the first
time, 10-15% is more realistic. 5-10% can be achieved if you engage a
specialist who really knows ERP and CRM validation and you engage them early in
the project planning. 10-15% is more likely if your own validation staff work
it out with a less experienced system integrator.
These figure are based on experience over the last 3-5
years, since the publication of GAMP 5.
You can view the webcast and hear all the other questions - and answers - by viewing the recording of the webcast. We hope that people found the webcast useful and that you’ll
be able to join us for the remaining webcasts in the ERP/CRM series – details of
which can be found in the ‘webcasts’ page on the Business & Decision
Life Sciences website.
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