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Market: Life Sciences - Pharma Sector: Pharmaceutical Production

Digitization of Standard Operating Procedures, Paperless Corporate SOPs

Digitization of Quality documents and sharing of controlled content and documents at all production sites.

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Success Stories

Market: Life Sciences - Pharma / Sector: Pharmaceutical Production
Application Areas: Quality, Production, Logistics, Environment and Safety, Compliance

Company Profile

Multi company pharmaceutical leader in the antibiotic sector with 10 sites throughout Italy with over 2,000 employees.

Adiuto Analysis

Our Method for Success Stories.

Criticality Highlighted (Weaknesses/Threats)

Different procedures for the same activity

The standard operating procedures drawn up by individual sites for corporate activities were different from each other

Low Perceived Quality Level

Difficulty in carrying out checks and negative perception of the expressed quality

Different people's activities at different production sites

Production workers working on multiple sites must operate differently to perform the same task

Regulatory Inspections / Controls

Low quality standard due to lack of corporate documents.

Opportunity Emerged (Strength/Opportunity)

Quality

The corporate management of procedures generates a stronger and transversal quality on all sites. The opportunity lies in the use of Adiuto in digitization and multi-site standardization of SOPs

Standardization of documents

All production sites adopt the same way of working as the headquarters. The Adiuto solution allows reaping the technological benefits of collaboration, sharing, and standardized digitization of documents

Time to time

The corporate strength is to allow each site to transpose content and documents with their natural organization times. Adiuto takes care of sorting SOPs for local transposition for all sites automatically and selectively.

Waste mapping according to the Lean approach

Identification of waste areas on which to make processes more efficient.

Defects

Time for the resolution of processing errors

Overproduction

Unnecessary production or incorrect planning

Waste of time

Waste of time in the process steps

Talent waste

Inefficient allocation of resources

Extra Processes

More work or higher quality not required

Useless Mobility

Inefficient handling of resources

Disorganization

Inefficient archiving or inventory

Transport not necessary

Unnecessary handling of products and materials

Waste of Time

Document duplication

Each SOP had been drafted, reviewed, and approved at each site, multiplying the time wasted by the number of locations. Adiuto has made it possible to centralize the document lifecycle, dramatically decreasing the workload at sites.

Extra Processes

Lack of corporate SOPs

There were no corporate SOPs, lacking due to the difficult paper management of documents between sites scattered throughout Italy. Adiuto has made it possible to standardize the documentation in each location by zeroing the distances between the sites.

Adiuto Approach

Solutions are identified, implemented, and customized.

What

Document lifecycle management.

Instant dissemination of documents and information to peripheral sites for the correct standardization of SOPs.

Lowering the time it takes for peripheral sites to transpose procedures approved by Headquarters.

How

Adiuto manages the assignment of the document drafting activities and the electronic approval signatures at the corporate level; it deals with the distribution of the document to the sites and the local transposition.

Who

The multisite operators, the Corporate Quality Assurance department, each site's local Quality Assurance Departments are the beneficiaries of Adiuto's solution.

Solutions

Enabled key users can launch a new Corporate SOP or revise a SOP currently in effect. The flow proceeds with a drafting phase with conversion of the draft to PDF. The Editors, the Reviewers and all the QPs of each site affix their signatures.

The flow continues allowing the upload of any forms (which will await the SOPs entry into effect) and the language version of the SOP. When all modules are approved, SOPs and Modules are put into effect and distributed to all plants for local transposition of the SOP.

Each QA at each site signs off on transposition, manages training, and chooses the effective date and possible destruction of previous editions of the SOP. At the end of the local approvals, each site has available the document in effect with all the corporate and local signatures.