? Professional Services

 

Comply's Professional Services group offers consultancy services covering a wide range of regulatory and compliance areas. Our goal is to provide you with hands-on expertise and guidance through the complexities of pharmaceutical regulatory compliance.   We maintain close contact with the life science industry, ensuring that the latest trends, new regulations and specific user requirements are regularly incorporated into our products, maintaining your competitive edge.

Standards and guidelines supported: 21CFRPart11, Annex 11, IEC62304, GAMP5, ICH8-11 , IEC 2304  
  • Data Integrity
  • Efficient and focused CS validation projects
  • IT project management in GxP environments
  • Identify, analyze and resolve regulatory issues
  • Suggest and implement smart SDLC process improvements
  • Perform Internal and vendor/audits
  • Define and implement preventative actions
  • Qualification with 21 CFR Part 11 and Annesx 11 requirements
  • Create SOP's and work instructions
  • Training in the area of CSV
Validation of Computerized Systems  
  • ERP and enterprise IT systems – Oracle OPM, SAP (with best practices for Pharma), Priority ERP, MFG Pro, Agile, Trackwise...
  • Laboratory and stand-alone systems - Labware, Empower, Dionex, Agilenet...
  • In-house developments – Validation of in-house developed applications
  • Excel – Development and validation of Excel applicationsplications Perform Internal and vendor/audits
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
Spreadsheet Development and Validation
Excel spreacsheets 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 spreadsheet development and validation. We have a proven methodology which includes 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.