2. Epitome Technologies
For Over a Decade Epitome Provides Compliance Solutions to Life
Science Industry.
Located in Western Part of India, Epitome has Clients all across India
as well as Other Demographics.
Highly Impressive Track Record of Completing Compliance Projects.
Continuous Updates on Technology and Compliance Fronts.
Team Headed by Experienced Professionals and Comprises of
Engineers and Pharmacists.
3. In today’s business environment
• As quality is the most important aspects of any manufacturing
process, it becomes necessary to validate or examine all the
peripherals connected to the manufacturing instrument used in
pharmaceutical industries.
• Among all these peripherals, computer is the main equipment, as it
controls and handles all the activities of manufacturing process
starting from input to finalized input.
• It is critical to design and validate them so that they fit for the purpose
and meet user requirement as well as compliance requirement.
• So the requirement of computer system validation (CSV) has naturally
expanded to encompass computer systems used both in the
development and production as well as in medical devices.
4. In today’s business environment
continue…
• There is a need for clarification of this very complex and often
misunderstood area of compliance.
• Apart from that, Validation of compute system is not once off event.
• Validation should be considered as a part of the complete life cycle of
a computer system.
• American FDA and UK MHRA regulate the guidelines for the use of
computer system in pharmaceutical industries
5. Why Computer Validation ???
• Required by the Regulations,
• US-FDA, EMA, GMP, GCP, GLP
• Increased system uptime through reduced failure rates, discover
costly detects before a system goes live.
• Ensure consistent data and product quality
• Helps to protect intellectual property (during development and
manufacturing of product) through scientifically sound data.
• Well defined and reviewed requirement specification ensures that
system meet expectation
6. What are the Regulatory and Quality
Standard ??
• Good Laboratory Practice
• Good Clinical Practice
• GMP Manufacturing Practice (APIs, Drugs, Devices)
• FDA’s 21 CFR Part 11/ EU Annex 11 (Electronic Records and
Signatures)
• GAMP 4, GAMP 5
• (Automated) Equipment should be suitable for its intended use.
• Equipment should be routinely checked.
7. What are the Regulatory and Quality
Standard ??
• Good Laboratory Practice
• Good Clinical Practice
• GMP Manufacturing Practice (APIs, Drugs, Devices)
• FDA’s 21 CFR Part 11/ EU Annex 11 (Electronic Records and
Signatures)
• GAMP 4, GAMP 5
• (Automated) Equipment should be suitable for its intended use.
• Equipment should be routinely checked.
8. Regulation Along with Drug Life
Basic
Research
Drug
Discovery
Preclinical
Developme
nt
Clinical Trial
I, II, III
Manufacturing
incl. API QC
Laboratories
Not Regulated GLP GCP GMP
21 CFR Part 11 Electronic Record and Signatures
Lead to drug
target
IND
Submission
and Review
NDA
Submission
and Review
Post
Marketing
Surveillance
Safety, Quality, Efficacy
GLP- Good Laboratory Practice
GCP- Good Clinical Practice
GMP- Good Manufacturing Practice
GxP- GLP+GCP+GMP= predicate rule
IND- Investigational New Drug Application
NDA- New Drug Application
9. What the Inspector Looking for ?
• Have the user been trained to understand the system, expected
performance and how to handle deviations ?
• Have system administrators been trained on GMP/Gxp ?
• Are URS traceable to test ?
• Are systems validated and is documentation complete ?
• How have changes been handled ?
• Are there system release criteria and are systems authorized for use ?
• Has SW been developed in quality environment ?
• Does the system ensure data integrity and availability (back-up) ?
10. FDA Warning Letter/483s
• Risk Assessment not Documented.
• Incomplete Validation of Data Acquisition system.
• New software Version not Validated.
• Computer System Configuration not Validated.
• Software patches not validated.
• Not all test scripts available.
• Test results don’t meet acceptance criteria.
• No Validation at User’s site.
• 3rd Party validation results not reviewed.
• Laboratory data manipulated or Data Integrity compromised
• And many more…..
11. Which System need Validation ?
• All computer systems that are used to create, modify, maintain,
archive, retrieved, or transmit regulated records.
12. Does my System Need Validation ?
• Does the system create regulated records ?
• Does the system maintain regulated records ?
• Does the system modify regulated records ?
• Does the system archive regulated records ?
• Does the system retrieve regulated records ?
• Does the system transmit regulated records ?
• Does the system support product release ?
• Does the system handle data that could impact product purity,
strength, identity.
If the answer is “Yes” to any question, it triggers validation
13. Why Epitome ?
• To meet Regulatory Requirements and
recommendations.
• Cost effective computer system validation.
• Initial and ongoing tests of software and computer system.
• Minimum validation documentation inspectors want to see.
• Serving Validation and use of excel spreadsheets and many more
services in regulated environment.
• Understanding the spirit and basics of the FDA Part 11 and the EU
GMP Annex 11.
• Ensure and document data integrity for part 11/EU GMP.
14. Our Work Flow Overview
a) Provide Overview Training to client executives about computer system
validation and applicability of US FDA 21 CFR Part 11 compliance.
b) Review the existing validation documents (format/content). The
general list of validation documents will cover,
– Validation Master Plan
– Risk Assessments
– User Requirement Specification (URS)
– Functional Requirement Specification (FRS)
– Qualification Protocols (NQ/IQ/OQ/PQ)
– Data Migration Protocol
– Traceability Matrices
– SOPs (IT related)
15. Our Work Flow Overview
d) Provide Additional Content (if needed) for validation documentation in
line with GAMP/ US FDA 21 CFR Part 11/ EU GMP Annexure 11.
e) Discuss and close the same with end user’s QA/ IT/ User Team.
f) Provide assistance to client team during protocol execution.
g) Prepare the validation summary report at the end of validation
activities.
h) Prepare Traceability Matrix against Requirement Specifications and
also against regulation such as Annex11
16. More Benefits from the Epitome !!!
• Successful completion of computer system and software validation
requires high level of compliance understanding coupled with domain
expertise on complex automation and software technologies.
• Lack of any one of them results in poor quality compliance mapping and
documentation often resulting in critical observation.
• To overcome this difficulty Epitome Technologies provides system
assessment services for the existing completion system and software.
• At the end of exercise a detail report is prepared by identifying the
areas of improvement.
17. More Benefits from the Epitome !!!
System Assessment
• To Carry out periodic audit of the validated computerized systems and
software’s to ensure post validation compliance.
• We shall depute our executives to your site to review the validation
status, system updates and change control.
1. Activities to be covered in assessment
– To review the SOPs
– To review the current user management
– To review any system Up-dates (new process or system modification) post
validation
– To review the change control documents for any system modification.
– To review regulatory impact of changes carried out.
– To review training records and updates there of.
– To updates the users and current regulatory expectations.
18. More Benefits from the Epitome !!!
System Assessment
2. Activities Not Covered in the Assessment
– Preparation of any fresh validation documents.
– Carry out validation of newly added processes/ plants/ hardware/ software.
– Preparation of any standard operating procedures.
3. Schedule,
Audit Frequency: Periodic Review and Audit – once every 6 months.
Duration: Approximately 3-4 days per site per visit.
Service provider will depute one or two of its executives for the audit.
Tenure of the Contract: This service contract shall be valid for period of 12 months
from the date of submission of validation summary report.
19. Our Services
• Lab System Validation
• IT Infrastructure Qualification
• PLC & SCADA Validation
• SAP/ERP Validation
• Validation of BMS System
• Validation of DCS system
• Spread Sheet Validation
• US FDA 21 CFR Part 11 compliance
• Maintaining Control in Operational (MCO) Services
• Validation of Clinical Research computer system Validation
• Training
• Periodic Review & Audit
22. Computer System Compliance
• For validation of computerized systems &
software applying risk based approach with
lifecycle management we follow
internationally accepted guidelines that is….
• We have successfully completed many
validation projects helping clients to meet their
goal of clearing international audits like US
FDA, EU, WHO, ANVISA, DMA…..
And many other
international
agencies
24. US FDA 21 CFR Part 11 Compliance
Introduction
• Part 11 is an FDA regulation that imposes certain requirements on
manufacturers when they choose to maintain FDA-required records in
electronic form. Its requirements are intended to help assure the
integrity, validity and trustworthiness of electronic records.
• Epitome Technologies undertakes various Computer System Validation
projects in the areas of Process Control Systems, Laboratory
Computerized Systems and Global Information Systems.
• Following GAMP guidelines, for this Epitome Technologies ensures
compliance to major International Agencies like US FDA / MHRA / TGA
etc for Computer System Validation and US FDA 21 CFR Part 11
Compliance for Electronic Signatures and Records.
25. US FDA 21 CFR Part 11 Compliance Audits
Scope
• Verification of implemented SOPs and practices
• Clause wise assessment of computer systems
• Finding out gaps and providing action report for gap closure
• Provide Part 11 traceability matrix
26. Our Trainings
• Computer System Validation Basics
• GAMP 5 based Validation Documentation
• Risk Assessment for Computer Systems
• CSV and Data Integrity
• Supplier Assessment
• Infrastructure Qualification
• How to comply with 21 CFR Part 11 and Annex 11
• Two days workshops on
– Process Control system validation
– Laboratory System Validation
– SAP Validation/ERP Validation
– CRO computer system validation
– CSV Data Integrity
27. Computer Systems Audits
• Verification of CS Management
• Verification of CSV documentation and reports
• Verification of implemented policies and user management
• Verification of CS based data integrity
• Verification of 21 cfr part 11
• Verification of Annex 11 requirements
