PROJECTS

Gap analysis and Action Plan management/implementation

Client: Dutch multinational operating in the health, nutrition and materials sectors (pharmaceutical products, medical instruments, personal hygiene products, food, etc.)

Sector: Pharmaceuticals

Objective: Carry out a gap analysis between the existing qualification documentation and what is required by the current regulations

Project

The company is a Dutch multinational operating in the health, nutrition and materials sectors (pharmaceuticals, medical instruments, personal hygiene products, food, etc.).

In order to use existing equipment and facilities in new production activities, the company needed to carry out a gap analysis between the existing qualification documentation and the requirements of the regulations.

Our contribution

  • The company turned to the specific expertise of the S4BT Qualification Team (equipment, environments, and utilities) which oversaw the project in all the following phases:

Gap Analysis, in which the S4BT Team highlighted the level of compliance of the existing qualification documentation with respect to the regulatory provisions and corporate and international standards (cGMP and FDA).

Action Plan. The “Gap analysis” provided the basis for:


  • the definition of all the actions to be taken in order to ensure full compliance of equipment and/or plant with company and international standards

  • the definition of priorities on the basis of the size and/or severity of the “gaps” found

Qualification Master Plan

Once the existing “gaps” and the appropriate activity plan were defined, the project QMP (Qualification Master Plan) was drawn up containing:

  • the objectives of the qualification activity
  • the responsibilities of the various professionals involved in the project
  • the qualification strategy to be adopted
  • the inventory of the equipment and/or plant involved in the project
  • the list of qualification documentation (eg DQ, IQ, OQ, PQ) to be drawn up for all equipment and/or plant

Action Plan implementation

Once the QMP was approved, the S4BT team was involved in the following activities:

  • Action Plan Implementation
  • Support in the management and planning of the various qualification activities
  • Drafting of qualification documents (DQ, IQ, OQ, PQ)
  • Support in the review of qualification documents and SOPs

Result

The project helped push the company even further towards a “Risk-based” approach. The work of the S4BT Team also made it possible to:

  • highlight all existing documentary gaps
  • eliminate all redundant qualification activities

For the client company this has translated into improved performance and greater efficiency.

CONSULTANCY SERVICES PURCHASED BY THE CLIENT COMPANY
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Project

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Projects completed in 2019
CLIENT

Pharmaceutical Company

An international pharmaceutical organisation specialising in the clinical and commercial development and production of pharmaceutical products with a high degree of toxicity.

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COMPLAINTS

An aid to inspection work

Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.

The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.

PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.

During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes

AUDIT

Documents and traces activities

It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.

The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.

PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.

Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes