data integrity seminars interesting linksdraft guidance april 2016 gmp data integrity, march 2015...
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©2017 Waters Corporation 1 COMPANY CONFIDENTIAL
Data Integrity seminars
Interesting Links
Arjan Timmerman
©2017 Waters Corporation 2 COMPANY CONFIDENTIAL
Disclaimer
This presentation is for informational purposes only and should not be
taken as advice regarding any particular course of action to be followed.
Waters does not make any representations or warranties, express or
implied, to any party, regarding use of the information contained in this
presentation to make decisions regarding the implementation and
maintenance of effective quality control systems and quality assurance
testing programs, including but not limited to the applicable Good
Manufacturing Regulations that apply to the manufacture of regulated
products.
©2017 Waters Corporation 3 COMPANY CONFIDENTIAL
Website Q and A 2015, DRAFT Guidance April 2016 GMP Data Integrity, March 2015
GxP Data Integrity, DRAFT July 2016
Medicines & Healthcare Products Regulatory Agency (UK)
Pharmaceutical Inspection Co-Operation Scheme
PI-041-1 (DRAFT 2), August 2016 Released June 2016,
as WHO_TRS_996 Annex 5
Q and A: August 2016
For GLP, April 2016
Data Integrity Guidances
Points to Consider Series: Conduct: March 2016
Fundamentals: Sept 2016 Coming soon
&
EPA QA/G-8, November 2002
©2017 Waters Corporation 4 COMPANY CONFIDENTIAL
Documents
Global Service Compliance: 720005222en
– www.waters.com/waters/library.htm?cid=511436&lid=134830333
Empower 3: 720001257en
– www.waters.com/waters/library.htm?cid=511436&lid=1529289
NuGenesis LMS: 720003597en
– www.waters.com/waters/library.htm?cid=134868917&lid=10178077
Laboratory Analytics: 720004900en
– www.waters.com/waters/library.htm?cid=134735510&lid=134793396
Professional Services: 720004190en
– www.waters.com/waters/library.htm?cid=134633953&lid=134902929
Power of Two: 720005340en
– www.waters.com/waters/library.htm?cid=134868917&lid=134847834
©2017 Waters Corporation 5 COMPANY CONFIDENTIAL
Documents on CSV and Service
Laboratory Analytics
– www.waters.com/waters/en_US/Instrument-Analytics-with-
Empower/nav.htm?cid=134735510
Compliance and Validation Service: 720004963en
– www.waters.com/waters/library.htm?cid=511436&lid=134788901
Empower Driven Services 365: 720004624en
– www.waters.com/waters/library.htm?cid=134735518&lid=134729087
Resource Management Report: 720004625en
– www.waters.com/waters/library.htm?cid=134735518&lid=10160465
Qualification / Compliance Services
– www.waters.com/waters/en_US/Software-and-Network-Compliance-
/nav.htm?cid=134633953
©2017 Waters Corporation 6 COMPANY CONFIDENTIAL
White Papers on Data Integrity
White Paper Data Integrity for Your Laboratory Computerized Systems by Lynn Archambault - 720005842en
– www.waters.com/waters/library.htm?cid=511436&lid=134899537
White Paper on PIC/S by Lynn Archambault - 720005687en
– www.waters.com/waters/library.htm?cid=511436&lid=134895831
White Paper on Backup vs. Archive by Waters corporation – 720005528en
– www.waters.com/waters/library.htm?cid=511436&lid=134872580
White Paper on Mastering Metrics to Enhance Lab productivity by Ben Dearnaley and Donna Wall – 720005015en
– www.waters.com/waters/library.htm?cid=134735510&lid=134806101
©2017 Waters Corporation 7 COMPANY CONFIDENTIAL
Videos -
Empower: Enterprise - Benefits Beyond the Workstation
– www.youtube.com/watch?v=2ldVVFNde6A
Empower: Maximize Your Lab's Productivity
– www.youtube.com/watch?v=7t6LL2L0cwo
Power of Two: Manage Your Empower Data with NuGenesis LMS
– www.youtube.com/watch?v=mxngcGgqPug
Paradigm: Scientific Search Software
– www.youtube.com/watch?v=pZVSvFrtwqI
UNIFI: Scientific Information System
– www.youtube.com/watch?v=uv1K9_9F9f4
www.youtube.com/user/WatersCorporation
©2017 Waters Corporation 8 COMPANY CONFIDENTIAL
Info Graphics / Information
Empower for the Enterprise: 720005714en
– www.waters.com/waters/library.htm?cid=511436&lid=134898038
Data Integrity Compliance: 720005667en
– www.waters.com/waters/library.htm?cid=511436&lid=134888351
Empower 3 CDS: 720005473en
– www.waters.com/waters/library.htm?cid=511436&lid=134865308
The Power of Two: 720005401en
– www.waters.com/waters/library.htm?cid=511436&lid=134847840
Service Solution on SQT
– www.waters.com/waters/library.htm?cid=511436&lid=1529332
©2017 Waters Corporation 9 COMPANY CONFIDENTIAL
Book CDS Validation
Validation of Chromatography Data Systems
Meeting Business and Regulatory Requirements
By: R.D. McDowall, RSC Chromatography
ISBN 0-85404-969-X
©2017 Waters Corporation 10 COMPANY CONFIDENTIAL
Regulatory Agencies / Bodies
www.fda.gov/
www.who.int/en/
www.gov.uk/government/organisations/medicines-and-
healthcare-products-regulatory-agency
www.ema.europa.eu/ema/
www.cdsco.nic.in/
www.picscheme.org/
www.pda.org/
www.oecd.org/
www.tga.gov.au/
www.epa.gov
eng.sfda.gov.cn/WS03/CL0755/
©2017 Waters Corporation 11 COMPANY CONFIDENTIAL
FDA – www.fda.gov/downloads/drugs/guidancecompliance
regulatoryinformation/guidances/ucm495891.pdf
WHO – www.who.int/entity/medicines/publications/pharmp
rep/WHO_TRS_996_annex05.pdf
MHRA – www.gov.uk/government/uploads/system/uploads/
attachment_data/file/412735/Data_integrity_definitions_and_guidance_v2.pdf
EMEA – ec.europa.eu/health/documents/eudralex/vol-
4/index_en.htm
– http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000027.jsp#section17
PIC/S – https://picscheme.org/useruploads/documents//PI_
041_1_Draft_2_Guidance_on_Data_Integrity_2.pdf
CDSCO – www.cdsco.nic.in/writereaddata/GMP%20Checklist.
EPA – https://www.epa.gov/sites/production/files/2015-
06/documents/g8-final.pdf
ALCOA
– www.southernsqa.org/newsletters/Summer10.DataQ
uality.pdf
PDA
– https://www.pda.org/scientific-and-regulatory-
affairs/regulatory-
resources/code-of-conduct/elements-of-a-code-of-
conduct-for-
data-integrity-in-the-pharmaceutical-industry
(registered download)
OECD
– http://www.oecd.org/officialdocuments/publicdisplay
documentpdf/?cote=env/jm/mono(2016)13&doclang
uage=en
TGA
– https://www.tga.gov.au/sites/default/files/tga-
presentation-give-pda-conference-july-2015.pdf &
https://www.tga.gov.au/sites/default/files/presentat
ion-data-integrity-international-regulatory-
perspective-160811.pdf
SFDA or CFDA
– http://www.sfda.gov.cn/WS01/CL0778/165110.html
Data Integrity Guidances
