Professional Services

Comply’s team is comprised of experienced senior System Analysts and Engineers in the field of Validation of Computerized systems, FDA 21 CFR Part 11 compliance, Acceptance Testing and the maintenance of the validated state of computerized systems.

The close contact we keep with the industry keeps us up-to-date on industry trends, new regulations and specific user requirements. This knowledge is also immediately embedded in our products.

Validation of Computerized Systems

Comply implements an effective methodology for validation of information systems. This methodology is derived from the FDA, EMEA and the GAMP 4 rules and guidelines. We have performed validation of many systems of varying complexity, including: 

• ERP – Oracle OPM, SAP (with best practices for Pharma), Priority and MFG Pro, Prism ERP.
• Large, off-the-shelf systems – MRO Maximo, Empower HPLC, Sparta Systems TrackWise
• In-house developments – Validation of in-house developed applications
• Excel – Development and validation of Excel applications

Validation of Information Technology Infrastructure

In order to comply with increasing regulatory demands, the IT infrastructure has come under the cGMP requirements. Regulators would like to see that the IT infrastructure is qualified and that it is managed and controlled in terms of reliability, security and integrity. This includes activities such as:

• Inventory of IT computerized systems from a GMP point of view.
• Validations of Servers and IT Infrastructure – databases, network, application servers.
• Maintenance Activities – scheduled and emergency maintenance, disaster recovery plans.
• Change Management – upgrades, system corrections, installations, decommissioning.
• Quality of Service – support processes, monitoring of systems.
• Information Security – access to information, data backup and restoration, employee retirement.

FDA 21 CFR Part 11 compliance

Comply has extensive experience with FDA 21 CFR Part 11 compliance. Our programs have been inspected and verified by the FDA and various external auditors

Excel Development and Validation

Excel applications are very common in organizations, but they pose a problem in terms of information security, data integrity and 21 CFR Part 11 compliance.

Comply has developed an expertise in Excel development and validation. We have a proven methodology comprising clear and effective system documentation together with smart and thorough testing strategies. This is coupled with expertise in software development in the Microsoft Excel environment, enabling us to create effective and valid applications.