Trinity Pharma Solutions helps companies evolve their IT infrastructures to comply with federal regulations such as the Sarbanes-Oxley Act and the FDA's 21 CFR Part 11. We help companies identify an acceptable level of risk, and then configure their IT systems and business processes to facilitate compliance with current and future regulations.
As part of that process, we address compliance issues that are across the life sciences industry, such as:
Archiving e-mail messages
Validating machines and applications
Documenting transactions
Protecting the confidentiality of key records
Utilizing compliant methods for standardizing, storing, retrieving, and delivering data
As those systems are established and implemented, we work with clients to develop the in-house skills and processes needed to maintain regulatory compliance over the long term.