Audit Readiness
Professional Information's skills, and the appropriateness of the systems and processes that are in place, have been confirmed through numerous UK MHRA Pharmacovigilance Inspections and client audits which have resulted in consistently positive outcomes with no significant findings for the Company.
As Professional Information currently participates in an average of two audits/inspections each month, the Company is in the unique position of being able to learn from multiple audits, ensuring continuous systems and process development to meet ongoing and emerging requirements.
Some examples of Professional Information's audit readiness policy include:
Training: Training records are maintained for all the training activities (general and project specific) and all the training is tracked electronically for ease of accessibility.
Document Managment: Robust Processes are in place to ensure currency of data in use.
Archive: Professional Information has its own on-site Secure Archive Strore for all key documents.
Quality Control: All items are QCd prior to leaving Professional Information following an item-specific QC process. In addition, all enquiries logged in a Professional Information database are QCd weekly. An accreditation process is in place for personnel involved in QC.
Quality Assurance: Professional Information maintains its own QA SOP and an in-house QA function. All QA activities including any corrective actions undertaken are documented.
