Whether it is a new or existing manufacturing facility our engineers can navigate their way through the regulations and help you set up a compliant and practical validation approach so you can have confidence that commissioning and qualification of facilities, utilities and equipment is done to the highest standard.
Our team of validation experts can generate key project documents, from Validation Master Plans, User Requirements Specifications (URS), Functional Specifications (FS) and Detailed Design Specifications, to meet your key requirements. Our documents are designed and laid out to promote the efficient generation of qualification protocols such as IQ, OQ and PQ. Our team will lead on implementing their knowledge and experience to colleagues with your organisation.
We offer a range of equipment commissioning and qualification services. Such as laboratory and manufacturing. Our consultants will use their experience from existing projects to ensure that critical quality attributes CQAs and Critical Process Parameters CPPs are identified and considered during the equipment validation. Our team can lead on Process & Test Methods validation as well as storage of key GMP areas and warehouses including your supply chain and distribution. We offer full CSV validation in line with GMP requirements and data integrity, working to current industry beat practices in alignment with ISPE.
- Facility Qualification & Commissioning
- Utilities & Equipment
- Process & Test Methods
- Storage & Distribution
- Computer Systems (CSV)
We can offer Validation contractors to support you throughout validation life cycle projects. OPS frequently executes validation projects on a fixed price basis or hourly basis, our experienced Validation Consultants and Validation Engineers can work with you on your site, leading the required training.