The document discusses computerized system validation and electronic records requirements. It provides an overview of US FDA regulations regarding computerized systems including 21 CFR Part 11, which establishes criteria for electronic records and electronic signatures. It also discusses concepts like closed and open systems, audit trails, electronic signatures, and the Good Automated Manufacturing Practice (GAMP) guidelines for computer system validation.

1. Computerized system validation
Jadhao Pravin H (M.Pharm 1st Year)
Department of Quality Assurance
School of Pharmacy, SRTMU Nanded
Cell No. 9604542553
Email. pjadhao54@gmail.com

2. Computerized system validation
Validation-(as per USFDA)
To established document evidence which provide high
degree of assurance that specified process will be
consistently produced product meeting its predetermined
specification and quality attribute.
 Computerized system validation (CSV) is the
documented process of assuring that a computerized
system does exactly what it is designed to do in a
consistent and reproducible manner.

3. CSV Regulations & Guidelines
• US FDA Compliance Policy Guidelines (CPGs)
• Drugs
 21 CFR Part 211 (211.68) – Automatic, Mechanical or
Electronic
 Equipment (cGMP for Finished Pharmaceuticals)
 Guide to Inspection of Computerized Systems in Drug
Processing, Feb 1983
 Guide to Inspection of Pharmaceutical Labs (July 1993)
 21 CFR 314 (314.70) – Supplements and other changes to an
 approved application (Applications for FDAApproval to
Market a new Drug)
 Computerized System in Drug Establishments (Feb, 1983)

4. ELECTRONIC RECORDS
Electronic Record-
Any record required for a Quality or Production purpose that is
held electronically.
e.g. Batch Records, Training Records, Customer
Complaint Records, etc.
Quality and Production paper records are legal documents they
can be and often are submitted as evidence in legal proceedings,
Altering/tampering with a paper record is fraud.
Electronic Records are the equivalent of paper records,
Altering/tampering with an electronic record is the same as
forging a paper record, it’s fraud

5. Electronic Records& the law.
• Quality and Production paper records are legal
documents they can be and often are submitted as
evidence in legal proceedings,
• Altering/tampering with a paper record is fraud.
• Electronic Records are the equivalent of paper records,
• Altering/tampering with an electronic record is the same
as forging a paper record, it’s fraud.

6. What are ElectronicSignatures
• Electronic Signature,
• Comprised of two parts,
• First part - publically known identifier
• Second part - known only to the owner of the esig,
• First part is typically a username to identify the user
uniquely and trace to their job role and training record to
verify that their authority level and competence to sign
for that job role.
• Second part is typically a Password (can be biometric
data) to ensure that it is actually the right person signing.

7. Audit Trails
• FDA has over 100 years of expertise inspecting paper records,
they can easily detect fraud with paper records,
• They known what they are looking for and can tell at a glance
if a paper record has been tampered with It’s harder to detect
fraud with an electronic record, it’svirtually impossible at a
cursory inspection.
• Computer Generated Time stamped Audit Trails are used to
give credence and providence to electronic records/electronic
signatures.
• Have to be able to provide a copy of the audit trail associated
with a particular electronic record to an FDA Inspector either
on paper/electronically the Inspectors request.

8. 21 CFRPart 11
• What does it mean?
• 21 – Chapter of US Federal Law – Food, Drug &
Cosmetics Act circa 1906,
• CFR - Code of Federal Regulation – US Federal
• Government Law,
• Part 11 – That part of 21 CFR that deals with
electronic records & electronic signatures.

9. What is Part11
• U.S. Federal Regulation to ensure electronic records are
trustworthy,
• Part 11 applies to all FDA regulated industries, where
electronic record keeping, signing and submitted is used
for systems with a Quality and/or Production purpose
that where implemented post 1997.

10. 21 CFRPart 11 - abrief history
• Created in 1997 due to the increasing adoption of
computerised electronic keeping in life science industry
and concerns with the integrity and robustness of
electronic records at that time.
• Enforced by the Food & Drug Administration FDA.
• PART 11 applies to all Drug and Medical Devices
manufacturers that sell into the United States and use
electronic records & electronic signatures.

11. Scopeof Part 11
• The current Part 11 covers;
• Electronic Record Keeping – any quality or production
record held electronically.
• Electronic Signatures - any approval of a quality or
production record that is committed electronically.
• Electronic Submissions - NDAs, 510(k)s, PMAs, etc…

12. Open vs. Closed Systems
• Closed Systems: those systems where a company can
verify the identify of all users before granting access to
an ERES system. Only electronic signatures required,
• e.g. username & password combination.
• Open Systems: those systems where a company cannot
verify the identify of all users before granting access to
an ERES system. Digital signatures are required in
addition to electronic signatures, e.g. digital certificates,
HTTPS, etc…
• This is to ensure that the person is who they say they are.

13. Good Automated Manufacturing Practice
(GAMP)
• The Good Automated Manufacturing Practice (GAMP)
Forum was founded in 1991 by pharmaceutical industry
professionals in the United Kingdom to address the
industry’s need to improve comprehension and evolving
expectations of regulatory agencies in Europe. The
organization also sought to promote understanding of
how computer systems validation should be conducted in
the pharmaceutical industry.

14. • Computer system validation following GAMP guidelines requires users
and suppliers to work in concert so that responsibilities regarding the
validation process are understood. For users, GAMP provides a
documented assurance that a system is appropriate for the intended use
before it goes “live.” Suppliers can use GAMP to test for avoidable
defects in the supplied system to ensure quality product leaves the
facility.
• If a life sciences company wishes to use GAMP guidelines to set up its
validation systems, some of the elements may already be in place.
Certain aspects, such as the maturity of the hardware or software, must
be taken into consideration to check whether these elements are
“industry proven.” To test the validity of elements in the system, the
appropriate hardware, infrastructure and network must be in place.
When beginning the testing environment, the test author should
understand the testing environment in terms of;

15. • * Correct hardware (peripherals and interfaces);
* Software (validated tools, software configuration);
* Data units (inputs, outputs, quality and quantity of
data);
* Procedures (especially for user acceptance testing);
and
* People (training and experience), (GAMP Good
Practice Guide, pg. 69).

16. REFERENCE
1) www.linkedin.com/groups/Training
Managers-Network-4868021
2