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- Market: Life Sciences - Pharma / Sector: Pharmaceutical Production
- Application Areas: Quality, Production, Compliance
Company Profile
Italian company that is part of a leading international pharmaceutical group. Not only pharmaceuticals, but also solutions and services that can improve the quality of life of patients suffering from disorders of the nervous system.
Adiuto Analysis
Our Method for Success Stories.
Criticality Highlighted (Weaknesses/Threats)
Paper Distribution
Documents no longer in use remained in the corporate areas.
Manual selection of the batch number
The choice of batch number, which was manual, could recover a batch that was no longer active.
Opportunity Emerged (Strength/Opportunity)
Improved inspection management
During inspections, the validated system, also through Adiuto's Audit Trail, allows transparency of the process.
Digital selection of batch number
The batch list is now updated with the production management system.
Best Quality Assurance work
Some activities (controlled/non-controlled printing, batch selection, electronic distribution, etc..) originally the responsibility of Quality Assurance are now delegated to other operating units, in full compliance with Quality and Regulations.
Inspections: Date Certainty
Documents through the Adiuto digital solution can be managed with a validated system that guarantees the secure date and veracity of the signatory through an electronic signature.
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
Defects
Distribution of Documents
The electronic distribution of documents "in use" allows the secure use of only the correct versions of the documents. The Master Batch Record is the product "recipe" - always having the correct recipe avoids errors during production.
Waste of Time
Paper distribution of documents is long and time consuming.
Printing and manual signatures, for each page, are very long processes. With the introduction of electronic distribution processes, everything happens automatically.
Extra Processes
Hard copy MBR
The QA was obliged to create a controlled paper copy of the MBR whenever it was to be used in production. On this hard copy, the QA would attribute the lot number and affix a signature.
Now the MRB document in use is in the system and enabled users can create an operational BR by taking an approved copy of the MBR and stamp the lot that is chosen from the management's active lots.
Adiuto Approach
Solutions are identified, implemented, and customized.
What
Drafting, verification and approval of the Master Batch Record and subsequent use in production of the corresponding operational Batch Record, on which Adiuto automatically affixes the variable data (batch number, expiration...).
Electronic management of the Master Batch Record drafting, verification and approval process.
Print management and security.
Electronic distribution for paperless display on PCs in the laboratory or in production.
Use in production of the MBR transformed into Batch Operating Record by affixing variable data (batch, expiration ...).
How
Through the introduction of Adiuto and a related drafting/verification/approval workflow, documents and their approval cycle were managed through the use of users' electronic signatures.
During the Adiuto Workflow, you can choose the document's visibility and to whom it will be distributed electronically.
Controlled/uncontrolled printing, subject to permissions, are stored in the system and the list of those made is available to facilitate reconciliation.
Who
The Quality Assurance department and the production/laboratory departments (which use the documents) are the beneficiaries of the project.
Solutions
A multi-step workflow involving QA editors, approvers, verifiers, and users has been developed. The QA ensures the flow's correct progress and can correct search indexes and recipients of subsequent activities.
The QA office defines the date of entry into force of the document. The automatic flow renders the previous documents obsolete, Adiuto manages the numbering of the MBR code.
The Word files from which PDFs are generated for distribution are in Adiuto and their viewing is subject to authorization.
Advantages
A summary of the main advantages of the Adiuto solution presented.
- A summary of the main advantages of the Adiuto solution presented.
- Data Integrity in relation to inspections
- Safety of the lot Applied
- Controlled Distribution
- Efficient and secure print management
Content and Process Management
Technological and methodological solutions for each critical process.
GMP - Quality Assurance Digital Solution
The solution for digitizing GxP & GMP Compliant processes
Read more
Processes Managed by Area
Application Areas of Process Management solutions.
Quality & Compliance
Standard processes, standard activities, controls and inspections: digital quality according to Adiuto
Read more
Production / Research and Development
Industry 4.0 as a paradigm enabling the advantages of digital in production processes
Read more