Creating Equipment qualification protocol

Y

Yunus

Registered
#1
#1
Good day...
Please how can I do qualification for an equipment already used in other company and supply to my company for use. Also, for a new facility just coming up, how do I go about the equipment protocol, am I going to create a single protocol for all the equipment or each for every equipment. Please I need an urgent respond. Besides, if there's any protocol document or template that can be of help please kindly farword to this mail [email protected].

Thanks
 
Download Free White Paper
Elsmar Forum Sponsor
P

pziemlewicz

Involved In Discussions
#2
#2
Here is a link on IQ / OQ / PQ: A Basic Guide to IQ, OQ, PQ in FDA-Regulated Industries

IQ is installation qualification: the installation in your facility is different from the other company, so you would not be able to use their data.

Each piece of equipment will have different requirements, which will drive different protocols. If you have multiple of the same equipment, they can use the same test protocol, but will need separate reports.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Creating a Quality culture! AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
L Hazardous Waste - Tips for creating standardized training Miscellaneous Environmental Standards and EMS Related Discussions 2
M Informational Creating a post market surveillance (PMS) system for medical devices – Part 1 Medical Device and FDA Regulations and Standards News 7
J Sample size for creating a data base as a reference to a tested variable Other Medical Device and Orthopedic Related Topics 6
8 Creating Flow and Pull Game Lean in Manufacturing and Service Industries 1
B Main responsibility for Control Plans - creating and maintaining FMEA and Control Plans 15
shimonv Creating a new commercial product based on a modification to an existing product Other US Medical Device Regulations 4
R Creating WIs for a Heavy Civil Engineering Services company Document Control Systems, Procedures, Forms and Templates 19
M Creating a Plant Level Value Stream Map Process Maps, Process Mapping and Turtle Diagrams 1
T IMDS - Creating an MDS out of material and a made item? RoHS, REACH, ELV, IMDS and Restricted Substances 4
D How do I go about creating document logs and registers with the MS Excel Excel .xls Spreadsheet Templates and Tools 2
W ISO9001:2015 - Clause 7.5.2 - Requirements for Creating & Updating Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
K Creating together Standard Definition for Prevention and Detection FMEA FMEA and Control Plans 1
Marc Creating an Internal Audit Program That Works for Your Organization Internal Auditing 0
M Creating change / Forcing change within a Company Lean in Manufacturing and Service Industries 7
A Creating a policy to evaluate the Third Party Security IEC 27001 - Information Security Management Systems (ISMS) 4
S Creating goals and objectives with targets and measurables for self-evaluations Management Review Meetings and related Processes 2
L Creating a xlsx Customer Complaint file to track Complaints Excel .xls Spreadsheet Templates and Tools 2
S When creating a 510k, which Guidance Document Wins? Other US Medical Device Regulations 9
P GS1 NHRN AIs - Creating Barcodes for Human Product Other ISO and International Standards and European Regulations 4
O Creating a Tool to Track & Verify Mistake Proofing Devices Document Control Systems, Procedures, Forms and Templates 5
B Any suggestion on creating the best paper plane that can hit a target perfectly? Coffee Break and Water Cooler Discussions 2
P Creating a PPAP document for my Suppliers APQP and PPAP 1
L Any recommendations on software for creating hierarchical workflows ? Misc. Quality Assurance and Business Systems Related Topics 2
AnaMariaVR2 Creating Global Giants from a Culture of Israeli Start-Ups Coffee Break and Water Cooler Discussions 0
R Creating a c-chart spreadsheet to use in my department Excel .xls Spreadsheet Templates and Tools 5
R Inspection Database Picker - Creating an Inspection Report Document Control Systems, Procedures, Forms and Templates 1
P Problem with creating VSM current map Lean in Manufacturing and Service Industries 3
G Creating an Organization Chart - AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
L Creating DHF (Design History File) for Medical Device Systems Design and Development of Products and Processes 8
Q Recommendations for criteria on creating a CAPA (Corrective and Preventive Action) ISO 13485:2016 - Medical Device Quality Management Systems 8
C Creating a Multiple Table SQL (Structured Query Language) Query in Minitab Using Minitab Software 10
C Resources for creating Process Validation Procedures Qualification and Validation (including 21 CFR Part 11) 5
B Creating an Audit Mechanism (System/Plan) General Auditing Discussions 3
A Customer Profiles - Creating a Customer 'Profile' for our Top 10 Customers Document Control Systems, Procedures, Forms and Templates 2
M Creating an Index for our Documents - Imaging Millions of Paper Records Document Control Systems, Procedures, Forms and Templates 13
N ISO 9001 based Audit Schedules: Creating and Maintaining - Template wanted General Auditing Discussions 5
P Creating a Traceability Database with Microsoft Access Document Control Systems, Procedures, Forms and Templates 7
V Creating a Cosmetic Inspection Specification for Powder Coated Painted Finished Parts Manufacturing and Related Processes 7
I Difficulty in creating a Quality Manual Quality Management System (QMS) Manuals 4
J Creating an Audit Schedule & Revamping QMS Internal Auditing 18
L How can you capture many positions held without creating a lengthy resume Career and Occupation Discussions 4
Miner Intro to MSA of Continuous Data - Part 10: Creating gauge families Imported Legacy Blogs 10
E Manufacturing Planning - Creating Improvements Misc. Quality Assurance and Business Systems Related Topics 7
R Creating Quality System and using it before it is complete ISO 13485:2016 - Medical Device Quality Management Systems 8
G Creating a "Records Policy" - Control of Quality Records Records and Data - Quality, Legal and Other Evidence 13
C Creating a Micro QMS - 4 geographical sites and 3 types of core activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Sources for Tips, Quotes with Graphics to be used for Creating Awareness? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R The difference between Deviation and Failure - Creating an SOP to handle them Food Safety - ISO 22000, HACCP (21 CFR 120) 24

Similar threads

Top Bottom