| (A)
Risk Assessment & Compliance Services |
|
cGMP Systems compliance consultants are
domain experts (most are faculty members
of the PDA-TRI and other industry
organizations).
Our services
include:
-
Risk Assessment & Risk-Based
Validation:
-
Customization of library
of assessment questions
& validation actions.
-
Creation of “master”
assessments for
system-types and
processes.
-
Inventorying of systems
and processes.
-
Facilitation of
assessment working
sessions and capturing
of results.
-
Creation of customized
reports
- Compliance
Audits
-
Validation: Facilities, Equipment, Cleaning, IS/IT, Process, 21CFR Part 11
- GMP
Systems Development
- Training
|
| (B)
Software Development Services |
|
cGMP Systems takes pride in our software
development methodology.
We utilize a modified waterfall
approach for our development projects
and have been successfully audited by
our pharmaceutical clients.
We use well-documented SOPs and
share our procedures with our clients.
Our experts develop products
using standard tool sets including:
- JAVA2
& J2E
- VB
- Oracle
- SQL
Server
|
| (C)
Project Management |
|
Recognizing cGMP Systems industry
expertise, many clients utilize our
teams to manage their projects.
|
