Operational Technologies Management Systems (OTMS)
All industries are striving to be more competitive by reducing costs and maximising the effectiveness of quality management systems, assets, software solutions and equipment across plants and production facilities.
The introduction and deployment of ISO9001:2015 requires companies to adopt a risk-based approach to quality management rather than a procedural fixed process approach and this has encouraged companies to adapt their Quality Management Systems.
Industrial Technology Systems Ltd (ITS) has significant practical experience in working within highly regulated industries including the pharmaceutical sector, an early adopter of the risk-based approach defined within the GAMP® guidelines. These guidelines classify systems and equipment by risk and detail the level of validation, testing and quality management required.
Rather than every system being called a Programmable Electronic System (PES), whether it is simply configured by software parameters or a complex PLC, SCADA or DCS based control system, GAMP® allows the systems to be treated differently through the category based approach. This creates a more flexible and efficient quality management process rather than a simple one size fits all, and this agile approach aligns with the risk based requirements within the ISO 9001:2015 guidelines.
ITS has significant experience integrating projects in the energy, chemical, nuclear, medical device and pharmaceutical industries gained over the last 30 years. We can draw on this experience, knowledge and practical application to develop, using a risk based approach, a specific Operational Technologies Management System (OTMS) and Quality Management System (QMS) specific to our client’s needs that is scalable. This also covers the management of lifetime records for the systems traditionally classified as Programmable Electronic Systems (PES).
With our experience in effectively controlling management records for traceability of changes, we are able to take your existing processes and “lean” them into a new OTMS and provide the ability to port the existing suite of documents and information into the new format.
If you want to save time in your existing PES environment and in managing appropriate lifetime records effectively, please talk to ITS’ team of experts.