At Denca we pride ourselves on a practical, straightforward and logical approach to delivering good documentation as part of every project. Working methodically, we ensure that the project requirements and purpose are clear. We also make certain that all elements of the process are traceable.
Effective documentation is key to consistently delivering projects that meet customer requirements and expectations, both on time and on budget. Documentation is more than paperwork. Effective documents mean customers can have total trust in us and the robustness of every single project we carry out.
Denca ensures that there’s good documentation from start to finish, from design through to installation and testing.
Phase 1: Design and Functionality Documentation
User Requirement Specification (URS)
Ideally, the customer supplies the URS. Where this isn’t the case, Denca will hold discussions with the customer’s responsible managers and engineers. We will work together to identify what they actually want and need. Denca will then create the URS and submit it to the customer. The customer must then confirm that the URS is correct before any work can commence.
Functional Design Specification (FDS)
From the URS we develop a detailed Functional Design Specification – FDS.
The FDS is a statement of what and how Denca will do to run the project from start to finish> The FDS must be both comprehensive and unambiguous. It also addresses Functional Safety See this article issues arising from the project which are thoroughly discussed and documented with the client with any RAMs and related additional documentation raised.
The FDS is checked by the customer and signed off as the basis for the project. Getting this right is key to avoiding potential problems later on.
The FDS may lead to further documentation, such as:
- Hardware Design Specification – This includes details of the actual hardware design and layout including component specification & the wiring layout. This document may not consider physical or site considerations. We consider these separately.
- Software Design Specification – A template for software development. This may not be so prescriptive and is more of a functionality specification.
Phase 2: Test to Specification Documentation
Internal Factory Acceptance Test (I-FAT)
This essential process checks that the new system performs to FDS requirements and highlights any errors. Before carrying out any installation, I-FAT also checks for operational robustness. This process can even extend to trying to break the system. This will demonstrate that it works robustly to the Functional Design Specification. Additionally, I-FAT tests help identify errors or other areas that need to be addressed.
Client Factory Acceptance Test (C-FAT)
Once the system passes I-FAT, we repeat the tests with the customer present. This is proof of performance to the client. C-FAT is a further opportunity to ensure that the FDS is both to the correct specification and that indeed it works!
Denca normally conducts both I-FAT and C-FAT on our own premises. Denca has extensive onsite test facilities.
Phase 3: Installation and On-site Testing
Following installation, systems are rigorously tested by Denca on-site at the customer’s premises to make certain that performance is up to specification. Once the Denca installation team is entirely satisfied that everything is in order, testing is repeated for the benefit of the customer.
As part of phase 3, it is also possible to test and document the on-site inputs and outputs to aid successful integration with existing plant and systems.
Sign-off of the on-site testing by the customer may signify the end of the project. However, if required (and it is often the case), Denca can produce comprehensive Operations Documentation and Training Manuals. We will also deliver systems training and support.
Pharmaceuticals Projects – An additional Documentation Layer
Projects for the Pharmaceutical, Healthcare and Life Sciences industries, demand tighter specifications. In these sectors, Denca work to ever stricter legal requirements; for example, as laid down by leading regulatory bodies including the US Food and Drug Administration.
It is also a requirement in these projects that the automated system must meet best practice as defined by Good Automated Manufacturing Practice (GAMP). Although GAMP does not have legislative standing, it provides very important guidelines for companies that develop and implement automated systems in the pharma sector.
GAMP 5 is the latest version. Denca works to ensure systems meet the GAMP 5 standards and that production processes are clear and scalable with the risk management over the entire system life cycle scientifically and quality based.
GAMP 5 guides both the customer and Denca towards good practices across the design, build, installation and all of the software. Denca produces thorough documentation for all elements.
In every project, our attention to detail in the documentation process is a real mark of our dedication and expertise and inspires confidence in our customers.