If we think of Documentation as a SPRINT deliverable, can we indeed have Agile and CSV?

Question on a LinkedIn group:

V model for Agile?

Life Science industry is using traditional V model for CSV. Should this model be changed for Agile based development, testing and validation.
I believe we should be able to use the user stories instead URS as the basis of V model. Please share your thought. Thanks

PJ Singh, PMP
Co-Founder & Director – Quality, Compliance, Validation, and Technology Integration

I’ve found out, during my tenure as Scrum PO for a GxP regulated product, that if you have a documentation resource, usually a Business Analyst, embedded in the SCRUM team, constantly making sure that there is documentation alignment between URS and User Stories, and make the documentation part of the Definition of Done, you can have a very strong alignment between V model and Agile practices.

I’m willing to propose and defend that, for implementing CSV while practicing Agile, one needs to have Documentation as a SPRINT deliverable.

A Portuguese abroad

Let it be known that the Minister who told the Portuguese people to seek a job abroad … was perfectly right! We are as good as anyone else in Europe, and probably in the world. Our great professionals are as good as the great professional of any other country.

Those who stay in Portugal deserve each other company… politicians more that the citizens.

After all, Portugal is today, what was made by those who did not participate in multiple Diasporas of the Portuguese peoples… Portugal is what the “Old Men from Restelo” built! We usually pride ourselves on the Discoveries… but we are descendants of those who stayed, who did not participate in the adventure.

On the other hand I miss Portugal dearly… and that is Saudade.

Travel

Traveling all the time… both for work and for family… 5 in the morning is now usual for me. Almost achieved Platinum level on KLM

 

Saudades

O melhor remédio é o Skype.

A seguir é a APP Sapo Jornais… Capas de jornais e notícias fresquinhas todas as manhãs.

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Que tal viver na Holanda? Clima

Quando faz frio, faz a sério. Quando faz vento… idem idem aspas aspas, que para as massas de ar que vêm do Árctico ou da Sibéria, a diferença entre a Holanda e o Mar do Norte é nenhuma.

O primeiro inverno foi um suplicio.

O de 2014 foi mais fácil, principalmente pela ausência de neve… mas chuva não faltou. O de 2015 ainda não teve neve a sério…

Calor… nunca tive. Seria mesmo capaz de jurar que nunca vi mais de 28 graus… e mesmo isso é mau: as casas estão feitas para manter o calor dentro… não sabem refrescar.

Outra coisa interessante: é possível saber, quase ao minuto, quando vai chover: O site Buienradar.nl mantém uma imagem completa e actualizada em tempo real de onde está a cair água em todo o Benelux. As previsões horárias (com 5 dias de antecedência) dão para programar uma ida ao supermercado ou uma volta ao lago!

New year, new life…

After a very hard year came evaluation season, and it was positive … in fact very positive …

The bosses clearly thought I was ready for new challenges. They have changed my job and I am now what I never thought I would become: a consultant. And a consultant who instead of having only customers in EMEA, is now responding to customers worldwide.

Interesting, too, that in the new roles I have, once again, to learn a lot of new things. This time around its the Code of Federal Regulations Ttitle 21, Chapter 11, EUudraLex Volume 4 Annex 11 and also PIC/S GMP GUIDE Annex 11. This more or less shows what I am doing, although it make no sense (at first glance) for a publisher editor of scientific journals and books.

Plus, all I learned last year about GAMP, is to be certified this year.

Regardless of the work ahead it is good to see that if it is recognized.

 

Primeira avaliação…

Ano novo, vida nova, etc, etc, mas  o que me faz mesmo arrancar hoje é o resultado positivo da minha primeira avaliação na empresa, hoje de tarde…

Um balanço de seis meses de aprendizagem e aferição da produtividade… com saldo positivo… e com o qual vieram também novas responsabilidades, objectivos e desafios.

אל על