Turn-key Projects - Solcom has built its unique in-house project execution programme, which consistently delivers entire solutions on time and on budget. Typically, these incorporate software, hardware and validation elements.
Our pragmatic approach delivers early system visualisations, click-ware prototypes and robust hardware / software test harnesses. Solcom works with your organization to develop the project from the Validation Master Plan to the final Performance Qualification, ensuring delivery consistent with expectations. This flexibility is especially helpful in organizations where a customer who is not specialist in IT buys the solution.
To aid the rapid development of projects Solcom has created a library of project components that are regularly reused. This toolkit contains:
- A complete project documentation template suite: including proposal, validation, specifications, test, user manuals, SOPs, commissioning, support and maintenance.
- Security modules (local and web based) to 21 CFR Part 11
- Configuration modules
- Device and instrumentation drivers
- Flowchart based system integration programming
- User interfaces
- Application modules
- Batch and continuous process management
- Centralised data storage and electronic records to 21 CFR Part 11
- Multi-language labelling and RFID
- Centralised reporting
- Web based system setup, access and reporting
- Installation and distribution tools
- Project schedules, plans and reporting
- Interfaces to legacy, commercial and analytical systems e.g. SAP, email etc.
The Solcom software toolkit ensures high-levels of code reuse and pre-validation which reduces time and cost. The consistent look and feel of these components is easily tailored to blend with pre-existing systems making the operator’s task easier, faster and less error-prone. In some cases, our own clients have deployed the toolkits.
The Solcom in-house quality system ensures that the whole system is developed in a way consistent with GAMP5, the ISPE guide to Good Automated Manufacturing Practise.
Post installation services include training, detailed User Manuals and online Help functions and where appropriate telephone / callout support on a 24/7 basis.