As a global leader specializing in providing a full scope of validation
services for computer systems, software and medical devices within pharmaceutical,
medical device and biotechnology companies worldwide, Arbour Group L.L.C. is well-credentialed
to identify, interpret and respond to emerging regulatory requirements as they impact
mission-critical elements of our clients' operations. One such area that commands
priority attention is the assessment of compliance with Electronic Records/Electronic
Signatures (21 CFR Part 11).
Our assessment services are designed to help clients ensure that electronic records
and electronic signatures are trustworthy, reliable, generally equivalent substitutes
for paper records and traditional handwritten signatures and that those functions
are in conformance with the requirements of 21 CFR Part 11.
Assessment Objective: Arbour Group's experienced professionals
are extensively trained to evaluate a client's use and documentation of electronic
records and electronic signatures as governed by applicable regulatory requirements.
The result of a Part 11 assessment project determines the effectiveness of a client's
process within a highly regulated environment and suggests the appropriate remedial
actions that might be necessary.
Assessment Procedure
Initiation Meeting: Arbour Group will conduct an initiation meeting
with the client's team to discuss specific details of the audit and describe the
process of the assessment. Topics covered typically include system evaluation, assessment
methodology and applicable regulations and industry guidelines, as well as the scope
and criteria of the assessment, consulting team composition, procedural logistics,
and reporting format.
Process: The assessment is conducted using Arbour Group's Part
11 Gap Analysis Methodology, which is adapted to accommodate the client's specific
environment and operating situation. The assessment will focus on six critical areas:
- Impact of 21 CFR Part 11 on the client's computer systems
- Identification of the client's computer systems and operating environment
- Hosting and interpretation of user interviews
- Review and consideration of client procedures
- Analysis of procedural documentation, validation and audit data
- Regulatory significance of the computer systems
Those areas of the assessment may be tailored to incorporate the following:
- Type of assessment (internal, second party, or third party)
- Method of electronic data handling and retention
- Level of the client's utilization of electronic records and electronic
signatures
- Business application of electronic information
Findings: Assessment findings will be analyzed in accordance
with various and appropriate requirements:
- Regulations
- Guidelines
- Compliance policy guides
- Warning letters and 483s
Results: The results of the assessment will be presented
to the client in a clear and concise manner and will discuss proposed remedial plans
and timetables and delineate the strengths and weaknesses of the client's use of
electronic records and electronic signatures. This presentation will be provided
in a summary format and will include detailed supporting evidence and reference
materials. The client will receive a final report, which will detail the assessment
findings, suggest interim measures, permanent remedial solutions, and project anticipated
results.