Computer Validation and Regulatory Compliance
IT'sQA provides experienced consultants in IT security and Computer System Validation (CSV) to ensure the systems used are validated to meet the predicate rules (GxPs) and comply with the requirements for electronic records and signatures.
We can support you throughout all stages of system validation life cycle by using and adopting methods that suit your organisation.
Our experience extends to a number of functional areas that include GMP, GCP, GLP, 21 CFR Part 11, infrastructure and data centres.
We provide the following services:
Pre-Audit Inspections/Gap Analysis
Working with the appropriate personnel in your company, we review your processes, quality system, policies, practices and SOPs for compliance with your responsibilities for computer systems used to generate data for marketing authorisation purposes. Working together we produce a report with observations and suggested corrective and preventive actions which, when implemented correctly, can prepare your company for an external/internal, regulatory audit and/or inspection.
Data Centre/Facility Audits
ITsQA can perform audits to assess your data centre and its suitability to host data securely and in compliance with the GxP regulations and industry expectations. This audit can include facilities, procedures and practices and may be conducted with IT specialists.
Contract Suppliers Audits
We independently evaluate contracted suppliers for their organisational ability to offer you the quality service you expect and ensure they are capable of fulfilling the obligations for the sponsor that they have been/will be contracted for.
Documents Audits
We conduct the QA review of the validation documents (User Requirements/Functional Specifications - URS and FDS; validation/test plans and reports) against other documents, records and current regulations to ensure validation of the computer system.
Compliance Audits
We review computer systems used in pre-clinical, clinical and manufacturing research to ensure they are validated to meet the GxP requirements.