We can follow your SDLC or we can also provide complete Validation Documentation Templates that only require modifications to suit the particular application and/or company procedures, thus eliminating the need to create new documentation.  All documentation is based on GAMP 5 recommendations.

All our Technical Writers are trained to support the internal IT Team in the technical writing requirements for the software and hardware installations, test and procedures, along with requirements definitions for any security, system administration and interfacing functions.

Additionally we will support the internal InfrastructureTeam in the technical writing requirements of equipment validation reports along with maintenance Standard Operating Procedures (SOP) drawings and spare parts lists.

Write Technical Reports, as needed, for Regulatory or Compliance requirements. Write, revise, and review Standard Operating Procedures (SOP), Work Instructions, (WI) as related to validation activities and system release.

Determine the need for complementary Policy, Standards, Guidelines or other documents in order to maintain a compliant and effective system.

Write, Review and Approve relevant validation deliverables while ensuring that project decisions do not conflict with quality and regulatory requirements which includes assessing changes arising from Computerized Systems and ensuring compliance to Quality System requirements.