Optimal’s commitment to cybersecurity and quality

At Optimal, we believe in delivering high quality solutions to provide our customers with high quality results. This way, we can effectively support even the most demanding industries.

We follow an advanced quality system for product development and projects, which incorporates Quality by Design (QbD) into all our activities. We have a full ISO 9001 and ISO 27001 accreditation and have been successfully audited both by our clients and suppliers. Standard procedures and guidelines are defined and enforced by a dedicated team of quality specialists. There are full product development lifecycle processes and procedures in place, which ensure that all deliverables are of a high standard. As with our software, we continuously monitor the performance of the quality system and, where beneficial, make improvements and updates to our quality policies to deliver consistently high results. Our dedicated teams provide validation services and comprehensive post-sale support. 

The team has built and developed individual machines and process skids to meet regulations such as FDA 21 CFR Part 210/211 – Pharmaceutical Industry GMPs, and FDA 21 CFR Part 11 – Electronic Records and Signatures. Optimal is also ISO accredited and has years of experience working within GAMP guidelines.