FDA 21 CFR Part 11

Definition of the term (“What is FDA 21 CFR Part 11?”)

FDA 21 CFR Part 11 is a set of re­gu­la­ti­ons in­tro­du­ced by the US Food and Drug Ad­mi­nis­tra­ti­on (FDA) in 1997. It de­fi­nes the cri­te­ria un­der which elec­tro­nic re­cords and elec­tro­nic si­gna­tures are con­side­red trust­wor­t­hy, re­lia­ble and equi­va­lent to pa­per re­cords and hand­writ­ten si­gna­tures. Es­sen­ti­al­ly, it sets the ru­les for the use of elec­tro­nic sys­tems in in­dus­tries re­gu­la­ted by the FDA. 

The in­tro­duc­tion of Part 11 was ai­med at mo­der­ni­s­ing and stream­li­ning re­cord-kee­ping pro­ces­ses in the phar­maceu­ti­cal and life sci­en­ces sec­tors. It should uti­li­ze the tech­no­lo­gy, but at the same time en­su­re data se­cu­ri­ty and in­te­gri­ty. The ne­ces­si­ty for such re­gu­la­ti­ons aro­se when the­se in­dus­tries in­cre­asing­ly in­tro­du­ced elec­tro­nic me­thods for recording.

What are the main requirements of FDA 21 CFR Part 11?

  • Elec­tro­nic si­gna­tures: One of the cen­tral com­pon­ents of FDA 21 CFR Part 11 is the use of elec­tro­nic si­gna­tures. The re­qui­re­ments for the use of elec­tro­nic si­gna­tures are de­fi­ned in or­der to be equi­va­lent to hand­writ­ten si­gna­tures. This in­cludes en­su­ring the se­cu­ri­ty and au­then­ti­ci­ty of the­se signatures.

  • Au­dit trails: FDA 21 CFR Part 11 re­qui­res the crea­ti­on of au­dit trails for elec­tro­nic re­cords. The­se au­dit trails ser­ve as a chro­no­lo­gi­cal re­cord of sys­tem ac­ti­vi­ties, en­ab­ling tracea­bi­li­ty and accountability.

  • Va­li­da­ti­on of elec­tro­nic sys­tems: Com­pa­nies must va­li­da­te their elec­tro­nic sys­tems to en­su­re that they meet the re­qui­re­ments of Part 11. This in­cludes ex­ten­si­ve test­ing and do­cu­men­ta­ti­on to pro­ve the re­lia­bi­li­ty and ac­cu­ra­cy of the system.

  • Ac­cess con­trols: FDA 21 CFR Part 11 also em­pha­si­zes ac­cess con­trols to en­su­re that only aut­ho­ri­zed in­di­vi­du­als have ac­cess to elec­tro­nic re­cords and sys­tems. This im­pro­ves data se­cu­ri­ty and pre­vents un­aut­ho­ri­zed changes.

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Achieve compliance

Steps to achie­ve com­pli­ance with FDA 21 CFR Part 11:

  1. Eva­lua­ti­on: Start by eva­lua­ting your cur­rent sys­tems and pro­ces­ses to iden­ti­fy com­pli­ance gaps. 
  2. Va­li­da­ti­on: En­su­re that your elec­tro­nic sys­tems are va­li­da­ted and that all soft­ware is pro­per­ly tes­ted and documented. 
  3. Ac­cess con­trol: Im­ple­ment strict ac­cess con­trols to pro­tect elec­tro­nic records. 
  4. Trai­ning: Train your staff on Part 11 re­qui­re­ments and best prac­ti­ces for elec­tro­nic re­cord keeping. 
  5. Au­dit trails: Es­tab­lish com­pre­hen­si­ve au­dit trails for elec­tro­nic records. 
  6. Do­cu­men­ta­ti­on: Main­tain de­tail­ed do­cu­men­ta­ti­on of all pro­ces­ses and sys­tem validations.

Advantages of compliance

Com­pli­ance with FDA 21 CFR Part 11 holds num­e­rous advantages:

  • Im­pro­ved data security
  • In­creased data security
  • Sim­pli­fied re­cor­ding management
  • Lower risk of re­gu­la­to­ry violations
  • In­crease in ope­ra­ting efficiency


In a di­gi­tal age whe­re data is king, FDA 21 CFR Part 11 plays a cri­ti­cal role in en­su­ring the in­te­gri­ty and se­cu­ri­ty of elec­tro­nic re­cords in the phar­maceu­ti­cal and life sci­en­ces in­dus­tries. By com­ply­ing with their re­qui­re­ments, or­ga­niza­ti­ons can not only meet re­gu­la­to­ry stan­dards, but also streng­then their data ma­nage­ment prac­ti­ces, ul­ti­m­ate­ly lea­ding to more se­cu­re and ef­fi­ci­ent operations.

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Frequently Asked Questions (FAQs)

To which in­dus­tries does FDA 21 CFR Part 11 ap­p­ly?
FDA 21 CFR Part 11 ap­pli­es pri­ma­ri­ly to the phar­maceu­ti­cal, bio­tech­no­lo­gy and me­di­cal de­vice industries.

Is com­pli­ance with Part 11 man­da­to­ry?
Yes, com­pli­ance with FDA 21 CFR Part 11 is man­da­to­ry for or­ga­niza­ti­ons ope­ra­ting wi­thin its scope.

What are the con­se­quen­ces of non-com­pli­ance with FDA 21 CFR Part 11?
Non-com­pli­ance may re­sult in re­gu­la­to­ry me­a­su­res, in­clu­ding fi­nes and pro­duct recalls.

Are the­re spe­ci­fic soft­ware tools de­ve­lo­ped for Part 11 com­pli­ance?
Yes, the­re are soft­ware so­lu­ti­ons ai­med at hel­ping com­pa­nies achie­ve and main­tain Part 11 com­pli­ance. You can find some of the­se tools here.

How of­ten should au­dit trails be che­cked?
Au­dit trails should be re­view­ed re­gu­lar­ly, with the fre­quen­cy de­ter­mi­ned by the organization’s risk eva­lua­ti­on and com­pli­ance policies.

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