SOP Management and Re-engineering

In the GxP area, the need for SOPs is undisputed. However, many organisations – large and small – struggle with determining the appropriate SOP content. Few manage to resolve the intrinsic conundrum well: some SOP users ask for detailed SOPs, others in the same organisations reject too detailed SOPs.

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More or less detail is not a question of right versus wrong, and this makes the dispute between the two groups difficult to resolve: depending on the organisational set-up, e.g. heavily relying on contract staff, operating in an area with frequent staff turn-over or using less skilled staff, detailed SOPs make much sense. Conversely, tasks performed by very skilled staff, especially if there is good business and process continuity, in-depth training can replace the detail in SOPs . Maintenance of SOPs to keep abreast of regulatory or organisational change is another challenge many companies struggle with. Considering that SOPs are generally the first documents that inspectors request and want to review, giving the right first impression with clear and up-to-date SOPs can determine the outcome of an inspection.

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How can Widler & Schiemann assist with your SOP management?
We have developed and successfully deployed a new approach to SOP management: first, the regulatory, legal and company policy “musts” are identified. In this project definition phase, your organisation benefits from Widler & Schiemann experience by our support to your teams, concentrating on “true regulatory and legal musts” for the procedure. To solve the SOP conundrum, we established a partnership with IMS Health, which brings Structured Content Management (SCM) expertise and technology to an SOP project. SCM allows the content of an SOP to be tailored to the specific needs of each user group, i.e. those groups or functions wanting a high level of detail will get detailed SOPs , those who prefer more streamlined ones won't be distracted by unwanted or “confusing” detail.

Widler & Schiemann will work with your experts and process owners to determine the essential process, as well as input and output that needs to be documented in an SOP . You will be able to draw from a library of standard SOP elements and templates to accelerate production of, and standardise management of, your SOPs . Widler & Schiemann together with IMS Health can bring your SOPs to the next level of simplicity and excellence by managing them in an SCM environment.

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