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GAMP 5 & Project Management


Labman’s Experience

Efficient and effective project management is a core requirement for bespoke automation and new products. Labman has developed, over many years, a series of in-house tools and procedures for managing projects ranging from small bench top systems to multi-million pound systems. Labman has a core set of procedures that meet ISO9001 compliance and a fully tailored intranet based project management suite. Project information can be retrieved in an instant, this covers important information such as customer contacts, project team details, system components, project status and progression, resource and compliance/testing data. Each project is detailed with a project plan and project update methods are mutually agreed with the customer, this may be in the form of emails, teleconferences, Skype video calls, site visits or a combination of all.

Labman projects typically follow a timeline according to GAMP 5 guidelines. The system design is documented in a Design Study and this is produced in response to dissemination of a customer URS. The Design Study provides a full specification for the system that includes key design elements for hardware and software, this covers aspects such as system dimensions, services, throughput, user interface design, operating procedures and input/output data. The Design Study usually progresses through several iterations after customer reviews until the final system specification has been concluded. Finally, the Design Study details all costs, options and timescales associated with the proposed system.

Further to production of the Design Study, Labman also produces the FAT and SAT specification documentation in conjunction with the customer. This allows us to provide a mutually agreed set of testing criteria to ensure the system meets the specifications as set out in the Design Study. During development of all systems the customer is welcome to visit Labman at any time to review progress and perform early testing of modules that may be ready in advance of the FAT. This provides a good opportunity for some unforeseen requirements or specifications to be changed prior to the system reaching completion.

Example Project Timeline

• URS (User Requirements Specification)

This may involve project meetings with the customer to refine the requirements and suggest improvements.

• DS (Design Study)

This may also involve project meetings to discuss the design face-to-face. Labman can provide presentations on the design proposal which in turn may highlight other options that may not have been considered at the URS phase.

• System Build

During the build phase, the customer is welcome to Labman at any time to view/review progress and suggest changes/optimisations.

• Module Testing

This is also a good time for the customer to visit as some modules may need testing with the customer present to ensure that they perform as expected e.g. a HPLC system may need to be tested with pre-prepared samples to ensure that it is performing as expected.

• FAT (Factory Acceptance Testing)

• Delivery and Installation

The project costs include delivery, installation and training at the customers site.

• SAT (Site Acceptance Testing)

  • Labman automation GAMP project management presentation powerpoint
  • Labman automation GAMP project management modelling design study 3D printed model alumide

Key capabilities.

GAMP & Project Management

  • Flexible project plans to meet customer timeline requirements
  • Joint production of URS documents where required.
  • Assigned project team contacts for efficient project communications during the lifetime of the project.
  • Ability to enhance/optimise existing customer procedures during work shadowing visits.
  • All systems are provided with a custom user interface based on what the customer wants and not on a generic software package.
  • All systems are provided with technical mechanical and electrical drawings and a copy of the system source code.

Example Systems.

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