Validated Reporting with StatSoft  

Offe­ring phar­maceu­ti­cal pro­ducts in the US or Euro­pean mar­kets, requi­res the pro­du­cing com­pa­nies to adhe­re to GMP (Good Manu­fac­tu­ring Prac­ti­ces) stan­dards. This includes a con­ti­nuous moni­to­ring of the pro­duc­tion and pro­duct qua­li­ty levels. The fin­dings are coll­ec­ted in reports (e.g. CPV, APR, APQR) that are filed and pro­vi­ded  to the regu­la­to­ry aut­ho­ri­ties like FDA and EMA. 

The moni­to­ring of the pro­duc­tion and qua­li­ty is accom­plished via sta­tis­ti­cal metho­do­lo­gy (like SPC). The results of the­se methods (dia­grams, KPIs, tabu­lar data) are trans­fer­red to reports. This is a reoc­cur­ring, labo­rious task that requi­res expert per­son­nel. 

The moni­to­ring pro­ces­ses - accor­ding to 21 CFR Part 11 – must be reason­ab­ly robust and have mecha­nisms to pre­vent mani­pu­la­ti­on. Only aut­ho­ri­zed per­son­nel should be able to make chan­ges to the pro­cess and inter­rup­ti­ons must be avo­ided. 

Orga­niza­ti­ons face many addi­tio­nal chal­lenges: 

  • Dis­pa­ra­te data sources and low data qua­li­ty  
  • Many reports must be crea­ted, a tem­p­la­te-based solu­ti­on is nee­ded 
  • Reports should be dis­tri­bu­ted to the stake­hol­ders auto­ma­ti­cal­ly 
  • Trans­pa­rent and repro­du­ci­b­le crea­ti­on of reports 
  • Results need to be available in inter­ac­ti­ve dash­boards to enable root cau­se ana­ly­sis 
Our Solution 

Stat­Soft sup­pli­es cus­to­mers in the phar­maceu­ti­cal indus­try (and life sci­en­ces) with tools and ser­vices to enable a con­ti­nuous and auto­ma­ted moni­to­ring of pro­duc­tion and pro­duct qua­li­ty. 

This includes a matu­re and estab­lished ana­ly­ti­cal plat­form (Sta­tis­ti­ca), that is enhan­ced with Stat­Soft-deve­lo­ped com­pon­ents and can exten­ded with visu­al data science dash­boar­ding (Spot­fi­re). 

The­se buil­ding-blocks form a powerful ana­ly­ti­cal plat­form whe­re the cus­to­mers stay in con­trol. Cus­to­mers can easi­ly use it and can harness it’s capa­bi­li­ties to tack­le many other ana­ly­ti­cal use cases as well. 

Stat­Soft has a long-run­ning expe­ri­ence with cus­to­mers in this indus­try and knows how to sol­ve indus­try-needs in the plat­form. This expe­ri­ence and the pre-built natu­re of the com­pon­ents gua­ran­tee a quick go-live, a tail­o­red set­up and relia­ble ope­ra­ti­on. 

 Approach 

As every cus­to­mer is uni­que, Stat­Soft sup­ports them along the way as a fair part­ner: 

  • Assess­ment and sel­ec­tion of soft­ware  
  • Archi­tec­tu­re of the sys­tem 
  • Instal­la­ti­on and set­up of soft­ware com­pon­ents 
  • Trai­ning of users regar­ding usa­ge and main­ten­an­ce 
  • Cus­to­miza­ti­on  
  • Docu­men­ta­ti­on rele­vant for the vali­da­ti­on of the plat­form  

 The main­ten­an­ce of the sys­tem can be sup­port­ed by Stat­Soft or stay ful­ly in con­trol of the cus­to­mer. Expan­si­ons to the sys­tem can be done by the cus­to­mer or with StatSoft’s help. 

The benefits 

StatSoft’s cus­to­mers for vali­da­ted report­ing are satis­fied cus­to­mers, becau­se chal­lenges are over­co­me quick­ly with joint forces.  

Some cus­to­mers have told us what expect to gain as effi­ci­en­cy boost from auto­ma­ted vali­da­ted report­ing: 

  • 35% redu­ced efforts for a sta­bi­li­ty stu­dy 
  • 75% reduc­tion for APR and MTR 
  • “Thou­sands” of work­hours saved for CPV 
  • Savings of 3.500 per­son hours in the par­ti­ci­pa­ting depart­ments 

Gains in effi­ci­en­cy in the­se depart­ments through auto­ma­ti­on can be very bene­fi­ci­al to the orga­niza­ti­on as expert per­son­nel can be assi­gned to much more valuable acti­vi­ties in R&D or for root cau­se ana­ly­sis. In addi­ti­on to the­se bene­fits, auto­ma­ti­on can help to redu­ce the likeli­hood of errors in the moni­to­ring pro­ces­ses and cor­re­spon­ding report­ing pro­ces­ses. 

Interested in validated reporting? We’re here to help!
Whether it’s implementing automated reporting, optimizing production monitoring, or ensuring GMP compliance, the StatSoft team is your trusted partner. Let’s work together to boost efficiency and future-proof your processes.
Contact us today!
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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
E-mail: info@statsoft.de

Sasha Shiran­gi (Head of Sales)