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  • Market: Life Sciences - Pharma / Sector: Distribution
  • Application Areas: Quality, Production, Compliance

Company Profile

Analytical laboratory that deals with the quality control of different companies' pharmaceutical products.

Adiuto Analysis

Our Method for Success Stories.

Criticality Highlighted (Weaknesses/Threats)

GMP Regulations

GMP Regulations for the management of electronic files require an unmodifiable file verified and approved by electronic signatures; in the specific case of Excel files, the file must be rendered unmodifiable in all its parts and unique in the system.

Management of disorganized documents

The management of disorganized laboratory documents risks handing over incorrect data to customers and control bodies.

Security of completed documents

The documents contain sensitive data that risks being counterfeited.

 

Opportunity Emerged (Strength/Opportunity)

Validated process

Adiuto allows a GMP validated management of the approval flow and compilation of Excel files.

Organized approval flow

Adiuto manages file archiving, their review, and approval flow.

Bulletproof Excel

Adiuto takes care of making the file unmodifiable, avoiding counterfeits and increasing its security.

Waste mapping according to the Lean approach

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

Difetti
Defects

Time for the resolution of processing errors

Descrizione
Overproduction

Unnecessary production or incorrect planning

Perdita di tempo
Waste of time

Waste of time in the process steps

Spreco del Talento
Talent waste

Inefficient allocation of resources

Processi Extra
Extra Processes

More work or higher quality not required

Mobilità Inutile
Useless Mobility

Inefficient handling of resources

Disorganizzazione
Disorganization

Inefficient archiving or inventory

Trasporto non necessario
Transport not necessary

Unnecessary handling of products and materials

Defects

Excel file security

The Quality Assurance office is responsible for converting Excel files compiled in the laboratory to PDF to make them unmodifiable; this file format change results in a loss of information related to the file type: the structure and formulas.

Adiuto manages the compiled Excel files' protocol, making them unique, writes the protocol code directly to the file, and makes it unmodifiable in all its parts; in this way, converting the file to PDF is avoided.

 

Waste of Time

Obsolete Master compilation

The compilation of an Excel by the technician requires subsequent quality control, first of all on the correct edition of the compiled file: if the latter is incorrect, the technician will have to repeat the compilation.
Adiuto makes only the current Master file available to the technician, avoiding the waste of time both in the incorrect compilation of an obsolete Master, and in the quality control.

 

Extra Processes

Technical checks on compiled files

The Excel file compiled by the laboratory technician is checked and approved by Quality. Many verifications made by the Quality Assurance office are technical checks that can be automated.

Adiuto automatically verifies that the sheet compiled in the laboratory is the edition of the Master in force and makes it unmodifiable in all its parts; it is no longer necessary to do technical checks on the file.

 

Disorganization

Disorganized management of the Master files

Managing valid versions and revisions of Master documents in shared network folders is at risk of accidental and unchecked changes and deletions. 
Adiuto manages the Master archive, the revision flow and entry into effect, and controls and manages accesses.

 

Adiuto Approach

Solutions are identified, implemented, and customized.

What

Management of Excel Master files and Excel files compiled in the laboratory.

 

How

Adiuto manages the entire life cycle of the Master: creation, entry into effect, revision, and disposal.
Adiuto takes care of tracing, making it secure and allowing the approval of Excel files compiled in the laboratory.

 

Who

The laboratory technicians and the Quality Assurance department.

Solutions

Masters are created and uploaded to Adiuto, where they are approved and put into effect.
Masters are downloaded by laboratory technicians and compiled. Once completed, the technician uploads the document.

Adiuto takes care of making the Excel file non-editable in all its parts, and verifies that it originates from a Master in effect.

If the master of the compiled file is not in effect, it is discarded and the laboratory technician is advised to report the data on the valid Master.

If the master of the compiled file is in effect, it is signed electronically by the technician, verified and signed by the Quality Assurance.

Advantages

A summary of the main advantages of the Adiuto solution presented.

  • A summary of the main advantages of the Adiuto solution presented.
  • Data security
  • GMP Compliance
  • Smart Repository
  • Organization of business flows
  • Automated controls
  • Protocol and uniqueness of the document

Content and Process Management

Technological and methodological solutions for each critical process.

GMP - Quality Assurance Digital Solution
GMP - Quality Assurance Digital Solution

The solution for digitizing GxP & GMP Compliant processes

Read more
DMS - Document Management
DMS - Document Management

The Document Management Solution

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Processes Managed by Area

Application Areas of Process Management solutions.

Quality & Compliance
Quality & Compliance

Standard processes, standard activities, controls and inspections: digital quality according to Adiuto

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Production / Research and Development
Production / Research and Development

Industry 4.0 as a paradigm enabling the advantages of digital in production processes

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