Ofni Systems ensures that your validation project clearly documents why your customers should share the high degree of confidence you hold in your company and your systems, while scaling the project to your organizational validation requirements and budget.One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system.
Paperless and Peopleless Plants: Trends in the Application of Computer Systems""; ""2.
Welcome to the first post in our series on Computer System Validation.
Pro Pharma Group provides a broad range of Computer System Validation (CSV) services in support of our clients’ manufacturing, laboratory, and enterprise systems.
We bring a full understanding of pharmaceutical, biotechnology, and medical device business processes to a practical, risk-based approach to CSV.
""Front Cover""; ""Contents""; ""Preface""; ""Foreword""; ""Contributor List""; ""1. Auditing Suppliers of Standard Software Packages""; ""15.
Paperless and Peopleless Plants: Trends in the Application of Computer Systems""; ""2. Auditing Software Integrators and Hardware Manufacturers""; ""16. Integrating Manufacturing Systems-A New Era in Production Control""; ""7.
Suppose that a document management system is being implemented at a young company in the pharmaceutical field.
GAMP is an industry guidance from the International Society for Pharmaceutical Engineering (ISPE) that if properly followed satisfies the FDA regulatory requirements applicable to computer systems in life sciences industry.
I will promote your education and experience so that your company is compliant with regulatory requirements and is self-sufficient." – David Nettleton …consider that David Nettleton has completed more than 240 software validation projects working step by step with the people that actually use the software.