Statistica in regulated Industries (like Pharma) 

Many com­pa­nies in regu­la­ted indus­tries such as phar­maceu­ti­cal manu­fac­tu­ring or life-sci­en­ces are using Sta­tis­ti­ca suc­cessful­ly in the domains of qua­li­ty assu­rance & con­trol and pro­cess moni­to­ring. 
We as Stat­Soft would in fact cla­im that the­se are the are­as whe­re Sta­tis­ti­ca deli­vers the hig­hest return on invest­ment. Why is that?  

  1. Sta­tis­ti­ca offers the ana­ly­ti­cal func­tion­a­li­ty that is requi­red in the­se fields. Loa­ding data, pre­pa­ring it, and ana­ly­zing it with the requi­red and other methods and to docu­ment the results pro­per­ly is ful­ly sup­port­ed by Sta­tis­ti­ca. All of that can be auto­ma­ted and manu­al modi­fi­ca­ti­ons can be redu­ced to a mini­mum. 
  2. Sta­tis­ti­ca offers a plat­form that satis­fies the requi­re­ments (stem­ming from regu­la­ti­on) regar­ding cor­rect­ness, pre­ven­ting mani­pu­la­ti­on and avo­i­ding pro­cess inter­rup­ti­ons (e.g. 21 CFR Part 11) and pro­ces­ses can be desi­gned in a way that they can pass a vali­da­ti­on.  

How does Sta­tis­ti­ca satis­fy the requi­re­ments that are given in (for exam­p­le) phar­maceu­ti­cal pro­duc­tion? 
Com­ple­te ana­ly­ses and ana­ly­ti­cal buil­ding blocks, data sources and models are mana­ged by Sta­tis­ti­ca Ser­ver in a cen­tra­li­zed repo­si­to­ry. Ser­ver has the fol­lo­wing fea­tures: 

  • Access rest­ric­tions with user rights and groups 
  • Appr­oval mecha­nisms ensu­re that chan­ges can only be made with a four-eyes prin­ci­ple. 
  • Ver­sio­ning of all ele­ments to let pre­vious ver­si­ons stay available. This way sys­tem modi­fi­ca­ti­ons can also be docu­men­ted. 
  • Audit Trails can be used to track chan­ges. 
  • The sys­tem can be deploy­ed on mul­ti­ple stages (e.g. DTAP or Deve­lo­p­ment + Pro­duc­tion).
  • Various ways to exe­cu­te pro­ces­ses: Manu­al­ly, sche­du­led or via Web­Ser­vice.
  • All ele­ments can be docu­men­ted to make team­work easier. 

In addi­ti­on, Sta­tis­ti­ca offers fea­tures that are very valuable in the­se indus­tries: 

  • A sys­tem for manu­al data ent­ry (for exam­p­le in the lab). With it you can digi­ti­ze data ent­ry, and avo­id mista­kes with various mecha­nisms like type checks, dou­ble blind ent­ry, and four-eyes prin­ci­ple. 
  • Sta­tis­ti­ca is a low code / no code envi­ron­ment that enables users to set up ana­ly­ses wit­hout any pro­gramming skills. This acce­le­ra­tes onboar­ding of new team mem­bers and can redu­ce the vali­da­ti­on efforts dra­sti­cal­ly. 
  • Sta­tis­ti­ca sup­ports all ana­ly­ti­cal methods that experts requi­re: Regres­si­on ana­ly­sis, com­pa­ri­son of means, non-para­me­tri­cal tests, sta­tis­ti­cal pro­cess con­trol, capa­bi­li­ty ana­ly­sis, qua­li­ty con­trol charts, design of expe­ri­ments, and many more. 
  • Pro­per docu­men­ta­ti­on of the algo­rithm ensu­res that the cal­cu­la­ti­ons lead to the expec­ted results. Sta­tis­ti­ca can be nume­ri­cal­ly vali­da­ted. 

The­re is much more in Sta­tis­ti­ca to ensu­re that cus­to­mers can make their pro­duc­tion more robust and gain insights. 

Don’t hesi­ta­te to get in touch! 

Learn more about Sta­tis­ti­ca here  

Latest News
Your contact

If you have any ques­ti­ons about our pro­ducts or need advice, plea­se do not hesi­ta­te to cont­act us direct­ly.

Tel.: +49 40 22 85 900-0

Sasha Shiran­gi (Head of Sales)