BioPharm Systems
has developed procedural documentation packages to assist companies establish
process standards in the following areas of: IT
Operations, Clinical
Data Management, and Product
Safety.
These packages
provide a basic set of Standard Operating Procedures (SOPs) and Guidelines
defining the technical and process requirements for efficiently planning,
preparing and managing your organization in the above areas. Each package
is comprised of the following components:
- Higher-level
SOPs (some are generic in nature, while others are specific for the use
with a particular system, e.g. Oracle Clinical).
- Guidelines
presented in a visual format, detailing how each procedure is performed.
- Forms and
templates to be used with the procedures.
- Standards
for critical functional areas.
- Roles and
responsibilities table defining who is responsible for performing individual
functions within each SOP and Guideline.
- A slide presentation
with instruction on how to customize the documentation.
- Worksheets
to help you customize the SOPs and Guidelines for your company's environment.
To obtain samples
of our procedural documentation or to ask questions, please contact us at
info@biopharm.com.
