If you’re in the Pharmaceutical / Clinical Research industry then you’ll know that you have some specific requirements when it comes to IT. FDA / MHRA regulations require that you can demonstrate your commitment to producing quality products or services. Some aspects of those regulations affect how you manage your IT systems and environment, which in turn affect your company as a whole.
Most businesses implement security and backup measures simply because that’s good practise. However, in regulated industries you are required to document, implement and demonstrate procedures in accordance with your company’s quality management system, which in turn is developed to drive and maintain your company compliance with regulatory requirements.
ITomica has over 20 years of experience in working within the Clinical Research industry and has developed suitable Standard Operating Procedures (SOPs) covering all areas of IT including all aspects of security, backup, disaster recovery, archiving, change control, the systems development lifecycle and validation. These SOPs have stood up to scrutiny from auditors, both internal and external. Everything changes with time, and as technology and regulations change we have worked with companies to review and update their SOPs accordingly
We have supported small CROs through rapid growth and multinational CROs. We have assisted with complex system integrations and over the years we have experienced and worked on numerous integrations occurring as a result of company acquisitions. We have also implemented suitable IT Helpdesk systems, coordinated office relocations, assisted with technology platform migrations – the list goes on.
If you feel that you would benefit from working with a flexible IT support services company with relevant industry experience then get in touch.
