The focus of this division is primarily the GxP business of pharmaceutical and medical device processing, equipment and installations, together with effective and efficient upgrades and refurbishments of all types of equipment, utilities and facilities. Quality Systems, Validation, Sterilisation, FDA, MHRA and ISO compliance are also areas of expertise. Our senior management team bring a wealth of experience having worked in this sector. Current Good Manufacturing Practice (cGMP) is at the forefront of the InforStrat solution culture.
For Pharmaceutical and Medical Device Manufacturing, InforStrat consultants have worked closely with FDA / MHRA inspectors to ensure GxP Facilities, IT Infrastructure, Process Equipment & Computer Systems have reached the required standard for their first inspection and inspections beyond.
Implementing quality systems, which comply with current regulatory requirements and cGxP is an area of InforStrat expertise. InforStrat can help with the following areas of potential Inspection observations, which have been a focus in recent inspections:
Complaints and Recall
Premises & Equipment
A Tailored Approach
Every company is different and as such has different needs. At Infostrat, we can tailor the support provided, bringing in the expertise of our professionals firm wide to ensure you receive the support you need. Our team of experts is available to support specific projects as required or to offer a full outsourcing service.
Our fees are flexible and structured to provide as much transparency and certainty as possible. We want our clients to be happy and know with absolute confidence what they are paying for.
Services we provide include:
Medical Device Validation
Manufacturing Equipment Validation
Computerised Systems Validation (CSV)
Business System Validation (BSV)
Manufacturing Enterprise Systems (MES/ERP)
Quality Management Systems (QMS)
Policy Implementation and Improvement
Laboratory Information Management Systems (LIMS)
Facility Design and Validation
Utility Design and Validation