IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems.

P

Pranesh

Registered
#1
#1
Hi All,

I am looking for IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems.

Looking forward to your support and guidance.
 
Download Free White Paper
Elsmar Forum Sponsor
A

Alex Kennedy

Registered
#2
#2
Good day All,
You do not give an indication of the size of your DCS system. I have written quite a few DCS system qualification documents and actually audited all the DCS suppliers on behalf of The big P. Because a DCS will be handling "critical data" the regulators will classify it as requiring "full life cycle validation". This is intensive validation and requires full documented history of the software, virtually - from concept to commissioning.
It is almost impossible to accomplish this without the full cooperation of the original software constructors/writers.
Validation Online's website carries extensive guidance information on the construction of cGMP protocols plans and others, but unfortunately DCS systems are usually pretty unique, very large and somewhat complicated requiring large authoring teams producing completely bespoke documents.
I am of course assuming that you are going to use the DCS within the cGMP environment - if not please discard all I have said.

Regards
Alex
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
V Protocol, report or SOP for threshold analysis? Human Factors and Ergonomics in Engineering 0
S Can anyone provide an example of Design Validation Protocol and Report? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
K Sample format for Equivalency Protocol /Report Using Minitab Software 5
Ajit Basrur Should the Protocol and Report be signed by the same person(s)? Qualification and Validation (including 21 CFR Part 11) 7
S What is the difference between a Test Protocol and a Test Report? Records and Data - Quality, Legal and Other Evidence 9
Ed Panek Audit Protocol? Simultaneous surveillance and recertification audits. ISO 13485:2016 - Medical Device Quality Management Systems 11
Y Creating Equipment qualification protocol Qualification and Validation (including 21 CFR Part 11) 2
placebo_master Risks of executing a verification protocol against existing data ISO 13485:2016 - Medical Device Quality Management Systems 4
dgrainger Informational DRAFT: The Medical Devices (Northern Ireland Protocol) Regulations 2021 UK Medical Device Regulations 1
M Sterile packing validation tests to be performed and protocol Other Medical Device and Orthopedic Related Topics 1
S Supplier protocol for the Quality Supplier Quality Assurance and other Supplier Issues 6
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
A Verification protocol example Design and Development of Products and Processes 2
K PQ validation qualification - Asked to write a PQ protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
D Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed? ISO 13485:2016 - Medical Device Quality Management Systems 6
D How to create IQ, OQ, PQ protocol for existing equipment Other Medical Device Related Standards 2
g_ehs Definition Protocol - for Assertions within Genetic Variant Databases Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
E Labware cleaning validation protocol example Qualification and Validation (including 21 CFR Part 11) 1
J EU countries and steam sterilisation protocol EU Medical Device Regulations 0
S IOQ protocol for a Micro-Vu measuring system - Is a PQ required? Qualification and Validation (including 21 CFR Part 11) 2
A Inspection Protocol Validation for a Medical Device Customer Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
S IEC 62366 - Usability Test Protocol format Imported Legacy Blogs 0
W Audit Protocol Manual which describes best practice Auditing Standards General Auditing Discussions 1
I Requirements for shipping items that fall under the Cartagena Protocol Various Other Specifications, Standards, and related Requirements 4
M Requirements, Verification Protocol and Reports All in One Document Design and Development of Products and Processes 6
E ISO Class 8 Cleanroom Qualification Protocol Template Other Medical Device and Orthopedic Related Topics 6
S Can any one share the Sorting Protocol? US Food and Drug Administration (FDA) 2
6 Accelerated Shelf Life Testing Protocol for Juice Containing Beverages Food Safety - ISO 22000, HACCP (21 CFR 120) 1
S Suitable Protocol for Isolation of Clostridium perfringens Food Safety - ISO 22000, HACCP (21 CFR 120) 2
C Reliability Testing Protocol on a new Peristaltic Pump Reliability Analysis - Predictions, Testing and Standards 14
W Production Equipment Cleaning Protocol Example Needed Other Medical Device and Orthopedic Related Topics 2
A Is an IDE required for a study protocol using phantoms and no humans 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Protocol of water activity measurement and suitable instrument Food Safety - ISO 22000, HACCP (21 CFR 120) 1
J Packaging Validation - IOQ Protocol template for a Sartorius Checkweigher Design and Development of Products and Processes 2
C Preparation for Product Validation Protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
S Medical Device Investigation Protocol Template for Health Canada Canada Medical Device Regulations 1
D Process Validation Protocol (API) as per new FDA Guidelines Qualification and Validation (including 21 CFR Part 11) 18
M Validation Process Protocol related to Medical Devices - Example ISO 13485:2016 - Medical Device Quality Management Systems 2
M Protocol for Validating Pull Tester and Force Gage Qualification and Validation (including 21 CFR Part 11) 9
Anerol C What protocol do you follow to stop the production line? Nonconformance and Corrective Action 9
K Final Acceptance Protocol and Customer Requirements Records and Data - Quality, Legal and Other Evidence 7
J Software Acceptance Test (Software Validation) Protocol template Software Quality Assurance 5
M Firmware Validation Protocol/template - FDA regulated Medical Devices industry 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B Process Validation Protocol for Injection Molding - Looking for training resource Book, Video, Blog and Web Site Reviews and Recommendations 1
Q PCBA Qualification Plan and Protocol example wanted Qualification and Validation (including 21 CFR Part 11) 1
A Protocol for Customer Audit Response General Auditing Discussions 3
S Internal Audit Checklist or a Protocol Guide wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
W WANTED: Product Stability Protocol - absorbable (resorbable) polymeric resins Other Medical Device and Orthopedic Related Topics 9
J Control of Product Drawings - Engineers don't follow the same protocol ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
R Clean Room AHU (Air Handling Units) - Good Protocol - Recovery Study Qualification and Validation (including 21 CFR Part 11) 8

Similar threads

Top Bottom