Computer Systems Validation
Need to upgrade a system but don’t know how to manage change control and validation? Want to keep your staff focused on time-critical projects? Don’t have the resources to devote to understanding 21 CFR Part 11 requirements?
Most companies don’t need full-time computer systems validation (CSV) staff. PharmaProSource® provides the expertise when you need it.
PharmaProSource provides senior level staff to formulate a CSV strategy, develop associated SOPs, and subsequently draft and execute validation plans. Our expertise includes performing the initial risk assessment and drafting requirements specifications, then creating test plans for the installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). We also create test scripts. A CSV project requires sufficient staff to allow adequate separation of duties. PharmaProSource provides a CSV team or just the staff you need to complete your team.
If you want to control the cost of software implementation and upgrade, ensure that test cases trace to elements of risk management, and increase your overall productivity, we will help. PharmaProSource enables you reduce the cost of CSV without increasing regulatory or business risk.