Standard Operating Procedure (SOP)

Definition of the term (“What is an SOP?”) 

SOP (Stan­dard Ope­ra­ting Pro­ce­du­re) is the Eng­lish term for the Ger­man term “Stan­dard­ar­beits­an­wei­sung”. This is to be un­ders­tood as a ty­pi­cal pro­ce­du­re or a stan­dar­di­zed se­quence of ac­tions de­scrib­ing pro­ces­ses with re­spect to va­li­da­ting the re­sults and do­cu­men­ting them, espe­cial­ly in cri­ti­cal sec­tors with po­ten­ti­al ef­fects on the en­vi­ron­ment, he­alth and safety.

Which sectors/industries need it? 

They are a re­qui­re­ment for the of­fi­cial aut­ho­riz­a­ti­on, espe­cial­ly in the phar­maceu­ti­cal in­dus­try. This espe­cial­ly af­fects the cer­ti­fi­ca­ti­on of pro­ducts and ser­vices. Sin­ce this is a re­gu­la­to­ry ap­pro­val, the aut­ho­ri­ty also checks the con­tent. It is in­ves­ti­ga­ted whe­ther the­re are vio­la­ti­ons of cor­re­spon­ding pro­ce­du­res. If this is the case, this can re­sult in va­rious con­se­quen­ces down to the pro­hi­bi­ti­on of sel­ling pro­duct or services.

Discover the right software for your SOP management

Whe­ther work / pro­cess in­st­ruc­tions (SOPs), pro­cess de­scrip­ti­ons, test spe­ci­fi­ca­ti­ons, ope­ra­ting in­st­ruc­tions, con­tracts or any other ty­pes of do­cu­ments — you can crea­te, re­vi­se and sign them di­gi­tal­ly with our “Do­cu­ment Con­trol” mo­du­le. Com­pli­ant with ISO stan­dards, EU-GMP, FDA CFR & more.

Live insight into the GxP-compliant document management system of d.velop Life Sciences

What are the benefits? 

Due to the pos­si­ble aut­ho­ri­ta­ti­ve sanc­tions, stan­dard ope­ra­ting pro­ce­du­res are stron­ger than or­di­na­ry work in­st­ruc­tions de­scrib­ing the pro­ce­du­res wi­t­hin an or­ga­niz­a­ti­on etc. Ad­di­tio­nal ad­van­ta­ges of elec­tro­ni­cal­ly do­cu­men­ted SOPs (en­ab­led by the mo­du­le Do­cu­ment Con­trol) are:

  • Ve­ri­fi­ca­ti­on and re­lease pro­ces­ses con­troll­ab­le with workflows
  • Com­pre­hen­si­ve do­cu­ment ma­nage­ment incl. versioning
  • Com­pli­an­ce with all requirements/regulations
  • Elec­tro­nic ma­nage­ment of your spe­ci­fi­ca­ti­ons (e.g. work /process in­st­ruc­tions, test spe­ci­fi­ca­ti­ons, hy­gie­ne plans, ope­ra­ting in­st­ruc­tions), form she­ets, con­tracts and other do­cu­ment types
  • Re­duc­tion of pro­cess run­ti­mes for crea­ti­on, re­vi­si­on, re­lease and dis­tri­bu­ti­on of specifications
  • Easy dis­tri­bu­ti­on of do­cu­ments and use of the si­gna­tu­re circulation
  • Re­duc­tion of un­ne­cessa­ry prin­touts and paper

What are the steps from the creation of an ASOP to it implementation? 

  • Do­cu­men­ta­ti­on (or pro­cess description),
  • Ve­ri­fi­ca­ti­on by a se­cond per­son with si­gna­tu­re and ap­p­lied ve­ri­fi­ca­ti­on criteria
  • No­ti­fi­ca­ti­on and trai­ning of af­fec­ted per­sons as well as
  • Chan­ge ma­nage­ment with op­ti­mi­zed do­cu­men­ta­ti­on and pos­si­b­ly in­for­ma­ti­on on the training

An SOP is do­cu­men­ted in a hand­book. It con­tains a dis­tinct ID, a ver­si­on num­ber, a date or pe­ri­od of va­li­di­ty and the na­mes and si­gna­tures of the creator, ap­pro­ver and re­lea­ser. This in­for­ma­ti­on en­su­red a com­pre­hen­si­ve tracea­bi­li­ty of a do­cu­ment. Mo­reo­ver, it must be re­cor­ded that the em­ployees of the or­ga­niz­a­ti­on were in­for­med of the con­tent of an SOP and must be no­ti­fied in case of a chan­ge to an SOP.

Discover the right software for your SOP management

Practical example of SOP management in the company:

Our com­pa­ny ex­amp­le is Mus­ter­mann GmbH. The last in­ter­nal au­dit in the pro­duc­tion de­part­ment re­sul­ted in ne­cessa­ry chan­ges and im­pro­ve­ments in the main­ten­an­ce pro­cess. In this case Er­win Er­stel­ler is re­spon­si­ble for this pro­cess. The company’s do­cu­ment con­trol sys­tem spe­ci­fies exact­ly which steps the do­cu­ment must go through be­fo­re the new ver­si­on is pu­blis­hed. The de­scrip­ti­on of the main­ten­an­ce pro­cess is de­fi­ned as a 4‑level do­cu­ment and the­re­fo­re goes through the fol­lowing steps:

1. Create/revise     2. Re­view     3. Ap­pro­ve     4. Re­lease     5. Train     6. En­act

(Click on the pro­cess steps be­low for more information)

Dokumentenumlauf d.3 life science sop management
SOP ma­nage­ment example

Our com­pa­ny ex­amp­le is Mus­ter­mann GmbH. The last in­ter­nal au­dit in the pro­duc­tion de­part­ment re­sul­ted in ne­cessa­ry chan­ges and im­pro­ve­ments in the main­ten­an­ce pro­cess. In this case Er­win Er­stel­ler is re­spon­si­ble for this pro­cess. The company’s do­cu­ment con­trol sys­tem spe­ci­fies exact­ly which steps the do­cu­ment must go through be­fo­re the new ver­si­on is pu­blis­hed. The de­scrip­ti­on of the main­ten­an­ce pro­cess is de­fi­ned as a 4‑level do­cu­ment and the­re­fo­re goes through the fol­lowing steps:

  1. Create/revise
  2. Re­view
  3. Ap­pro­ve
  4. Re­lease
  5. Train
  6. En­act
1. Crea­te | Revise

Er­win Er­stel­ler crea­tes a new do­cu­ment ba­sed on a tem­pla­te or an exis­ting do­cu­ment, or crea­tes a new ver­si­on of an exis­ting SOP, for ex­amp­le. Of cour­se, he can also in­vol­ve several edi­tors in the crea­ti­on pro­cess. Af­ter crea­ting or mo­di­fy­ing the do­cu­ment, Er­win Er­stel­ler sets the do­cu­ment cir­cu­la­ti­on (re­view, ap­pro­val and re­lease) and fi­nis­hes the edi­t­ing. Using the work­flow sys­tem, the do­cu­ment is au­to­ma­ti­cal­ly for­war­ded to the re­spon­si­ble re­view­er (one or more), who re­cei­ves a cor­re­spon­ding task.

2. Re­view

In this step, the con­tent check ta­kes place. Paul Prü­fer, the re­spon­si­ble re­view­er of the do­cu­ment, opens his task and stu­dies the con­tents of the do­cu­ment sent to him. He has the pos­si­bi­li­ty to ap­pro­ve the do­cu­ment and thus pass it on to the next stee­ring step or to re­ject the do­cu­ment, to add comments/comments/wishes for chan­ges and to send it back to Er­win Er­stel­ler. In ad­di­ti­on, en­qui­ries can be pla­ced about the do­cu­ment. If the do­cu­ment is ap­pro­ved it will be for­war­ded to Ge­rold Ge­neh­mi­ger.


Learn how the pro­cess can be im­ple­men­ted digitally:

d.3 life science document circulation: step Review

3. Ap­pro­ve

In the cour­se of the ap­pro­val Ge­rold Ge­neh­mi­ger has the same options/functions as Paul Prü­fer. If he dis­co­vers for­mal er­rors or ge­ne­ral­ly ne­cessa­ry cor­rec­tions need to be made, he can add his comments and send the do­cu­ment back to the creator. If Ge­rold Ge­neh­mi­ger ap­pro­ves the do­cu­ment it will be sent to Fried­rich Frei­ge­ber for approval.


Learn how the pro­cess can be im­ple­men­ted digitally:

d.3 life science document circulation: step Approval

4. Re­lease

The de­part­ment head Fried­rich Frei­ge­ber is re­spon­si­ble for the re­lease of the do­cu­ment or the new re­vi­si­on. If the­re are no ob­jec­tions, he con­firms the re­lease by me­ans of a di­gi­tal si­gna­tu­re and com­ple­tes the work­flow for the do­cu­ment as such. In the re­lease, Fried­rich Frei­ge­ber can de­fi­ne va­li­di­ty dates such as va­lid from, va­lid un­til (pe­rio­dic re­view) with re­fe­rence to the do­cu­ment and, among other things, de­fi­ne trai­ning coordinators.


Learn how the pro­cess can be im­ple­men­ted digitally:

d.3 life science document circulation: step Release

5. Train

With the re­lease of a new do­cu­ment or re­vi­si­on, a trai­ning re­qui­re­ment is ge­ne­ra­ted. All em­ployees who need to know this do­cu­ment will re­cei­ve a trai­ning task wi­t­hin the sys­tem. The au­to­ma­ti­cal­ly for­med qua­li­fi­ca­ti­on ma­trix shows you at any time at the push of a but­ton which trai­ning le­vel your em­ployees have. In the area of trai­ning, a va­rie­ty of trai­ning ty­pes (rea­ding trai­ning, rea­ding trai­ning with elec­tro­nic exam, e‑learning, face-to-face trai­ning, etc.) are available.


Learn how the pro­cess can be im­ple­men­ted digitally:

6. En­act

Af­ter the de­fi­ned trai­ning pha­se, the do­cu­ment au­to­ma­ti­cal­ly ta­kes ef­fect (un­less con­fi­gu­red other­wi­se). The do­cu­ment re­mains va­lid un­til a new ver­si­on is crea­ted and the do­cu­ment cir­cu­la­ti­on starts again. Short­ly be­fo­re reaching (time pe­ri­od in­di­vi­du­al­ly selec­ta­ble) the spe­ci­fied va­li­di­ty date of the do­cu­ment, a task for pe­rio­dic re­view is au­to­ma­ti­cal­ly sent, usual­ly to the creator. The re­ci­pi­ent can, if no chan­ges are ne­cessa­ry, ex­tend the run­ti­me of the do­cu­ment by ano­t­her cy­cle. If chan­ges are ne­cessa­ry, a new ver­si­on is created.


Learn how the pro­cess can be im­ple­men­ted digitally:

d.3 life science document circulation: document circulation

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