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. Conform to ISO standards, EU-GMP, FDA CFR & more.
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.
Start your digital transformation with our powerful, modular SOP management software solution
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)
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:
- Create | Revise
- Review
- Approve
- Release
- Train
- Enact
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.
Learn how the process can be implemented digitally:
Learn how the process can be implemented digitally:
Learn how the process can be implemented digitally:
Learn how the process can be implemented digitally:
Learn how the process can be implemented digitally:
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:
- Create | Revise
- Review
- Approve
- Release
- Train
- Enact
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.
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:
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:
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:
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:
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: