|
 Services
Overview
Process
Vendor
Audit
SOPs
and SWPs
|
|
Validation
Services
ClinicalSoft provides full and incremental validation services
for Clinical and Safety Data Management Systems. Our clients include
large pharmaceutical companies, CROs and biotech companies. Our
extensive product knowledge, industry experience and understanding
of regulatory requirements enable us to provide superior validation
consulting services.
Validation
Overview
Validation
establishes documented evidence providing a high degree of
assurance that a specific computerized process or operation
will consistently produce a quality result meeting its predetermined
specifications. The most important goal is to document that
a system consistently does what it is intended to do.
ClinicalSoft
provides full validation services including but no limited to
the following:
- Validation
Project Management
- Validation
Requirements Consulting
- Test
Script Development
- Test
Script Execution
- GAP
Analysis
- SOP
development
- SOP
review
- Post
Validation Implementation Services
The
Validation Process
The
validation process generally follows a System Development
Life Cycle (SDLC) methodology and generates a set of documents
that show the system is performing according to its design
specifications.
A
Validation Project should be a part of the SDLC and should begin
at the requirements phase. The following deliverables are generally
included in the validation process:
| Validation
Plan |
The
Validation Plan contains the definition and scope, roles
and responsibilities and the description of each deliverable.
|
| Functional
Requirements |
Includes
the system description, the purpose of the system, the user
requirements and a prioritized table of users "must have"
and "want to have" items.
|
| System
Design |
Includes
security and system specification. This document describe
show the system functionality will satisfy the users' Functional
Requirements. It also addresses Functional Requirements that
cannot be met and why.
|
| Traceability
Matrix |
Lists
each functional requirement and shows that it was addressed
either by being included in the system or indicating why not. |
| Installation
Qualification (IQ) |
Documentation
to verify that all key aspects of the installation adheres
to the appropriate design intentions and specifications. The
documentation contains instructions for installing and verifying
the installation of the hardware and software. |
| Operational
Qualification (OQ) |
Documentation
and testing to demonstrate that the system components perform
as intended throughout all anticipated operating ranges.
|
| Performance
Qualification (PQ) |
(User
Acceptance Testing)- Document and verify that the process
and total related system components performs as intended throughout
all anticipated operation ranges. Typically this document
would include: response times, system capacity, and user acceptance
tests.
|
| Summary
Reports |
Result
of the testing and what will be done to address any shortcomings. |
| Other
Documents in a Validated System |
Change
Management
Vendor Requirements
Design Documents
Training Class Descriptions and Sign-off
User Manuals
SOP's
Security
Operational Support
Contingency Plan
Record Retention
Periodic Review
System Maintenance |
The
Vendor Audit
The
purpose of the Vendor Audit is to determine the vendor's outlook
and philosophy on quality, documentation, and compliance to FDA
standards and industry guidelines. In addition, the audit helps
establish that the vendor has used an organized methodology to
build a verifiable, validatable system and that such a system
can be supported throughout its economic lifetime. The vendor
audit frequently includes a site visit.
SOPs
and SWPs
Standard
Operating Procedures (SOPs) and Standard Working Procedures (SWPs)
pertinent to the use of the computerized system should be available
on site. According to the FDA’s Guidance for Industry:
Computer Systems Used in Clinical Trials SOPs should be established
for, but not limited to:
- System
Setup/Installation
- Data
Collection and Handling
- System
Maintenance
- Data
Backup, Recovery, and Contingency Plans
- Security
- Change
Control
Most
pharmaceutical companies have established a much broader set of
SOPs. Click here for
a representative listing of SOPs and SWPs for a pharmaceutcial
company.
|
