Retention time requirement for various for quality records

S

ShaniQA

#1
Hello everyone,
I'll appreciate your help- I'm trying to establish a retention policy for our quality records.
On our last surveillance audit we were told that batch records should be saved for 15 years according to the European directive. I'm trying to find the reference for this guidance; maybe someone can refer me to it?
Our product shelf life is 2 years (long term implant, class III).
I'm trying to figure out for how long I need to retain the other quality records such as:
- Expired procedures (5 years?)
- Change orders
- CAPA forms
- Non-conformities reports
- Costumer complaints
- Internal audit records
- Management reviews
- Risk assessments
- Employees training sheets
- Process control logs – daily calibration, cleaning records, clean room​
monitoring, pest control, etc.)
Thank you in advance,
Shani.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
I Is Sample Retention for Batch Production a TS 16949 Requirement Records and Data - Quality, Legal and Other Evidence 4
C What is the Minimum Regulatory Requirement for Record Retention of DHR by Suppliers Records and Data - Quality, Legal and Other Evidence 9
P PPAP samples retention time IATF 16949 - Automotive Quality Systems Standard 5
M Retention period of documents and records ISO 13485:2016 - Medical Device Quality Management Systems 1
B Retention Samples when Customer Leaves Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
D IATF16949 7.5.3.2.1 Record Retention - Our Product or Customer Product? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
R Document Retention - Discard hard-copies after scanning? ISO 13485:2016 - Medical Device Quality Management Systems 2
M Defining and Documenting Record Retention CE Marking (Conformité Européene) / CB Scheme 5
Q AS9120B flow down to external providers: Records Retention AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
WEAVER Retention of golden samples for GR&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
N ISO 13485 Quality Record Retention Period ISO 13485:2016 - Medical Device Quality Management Systems 4
L VDA 1 Documented Information and Retention (new revision 4, August 2018) VDA Standards - Germany's Automotive Standards 0
Gman2 Quality Record Retention (Internal Audits, CA's) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Mobile app data privacy - Length of record retention in a software app Medical Information Technology, Medical Software and Health Informatics 1
L Pest Control Log Retention Time Frame ISO 13485:2016 - Medical Device Quality Management Systems 5
T MDR - Regarding the “Retention Period” of Documents and Records CE Marking (Conformité Européene) / CB Scheme 6
S. Moore Record Retention - How long must a company keep the following records? Records and Data - Quality, Legal and Other Evidence 17
K Our local sterilizer is closing - Record Retention Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Record retention for defunct customers? ISO 13485:2016 - Medical Device Quality Management Systems 11
A Determining Retention Period for Medical Device QMS documents Document Control Systems, Procedures, Forms and Templates 5
D Document Retention Policy IATF 16949 - Automotive Quality Systems Standard 5
B Interpretation of Customer Specific Requirements of Continental - Records Retention Customer and Company Specific Requirements 6
T Record Retention Requirements - IATF 16949 Clause 7.5.3.2.1 Records and Data - Quality, Legal and Other Evidence 15
D PMA A&P Document (i.e. Promotional Brochures, Flyers) Retention Requirements Other US Medical Device Regulations 10
J Retention Requirements of Complaint Medical Devices Customer Complaints 2
Pmarszal FDA Global UDI Database: Record Submission Retention Other US Medical Device Regulations 1
WCHorn Flowdown of Aerospace record retention requirements (AS9100) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
L GMW15920-2010 Records Retention for GM Customer and Company Specific Requirements 3
x-files Control of Records - Retention Time vs. Retention Period Document Control Systems, Procedures, Forms and Templates 5
V Tie-wrap pull test to verify contact retention Manufacturing and Related Processes 6
P Records Retention and Disposition - ISO 9001:2008 Requirements Records and Data - Quality, Legal and Other Evidence 5
D Production Record Retention Requirements Records and Data - Quality, Legal and Other Evidence 9
V Inactive Gauge Retention Time - PPAP Section 6 Requirements APQP and PPAP 1
D Contact Retention Tools Question General Measurement Device and Calibration Topics 3
C Financial Records Retention Requirements for a Manufacturing Company Records and Data - Quality, Legal and Other Evidence 3
S Retention of Training Records question Training - Internal, External, Online and Distance Learning 2
S Are there any new FDA requirements on Record Retention ? US Food and Drug Administration (FDA) 4
J Should Documents and Records Retention pertaining to Implants retained for 15 years? Document Control Systems, Procedures, Forms and Templates 7
C Retention of Clinical Trial Data after a Clinical Trial has ended Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5
H Layered Process Audit Hard Copy Records Retention Records and Data - Quality, Legal and Other Evidence 6
S Aerospace Record Retention Requirements Records and Data - Quality, Legal and Other Evidence 5
F AS9100 Records Retention Time Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D Question... Record retention Prior to FDA NDA application and approval Records and Data - Quality, Legal and Other Evidence 3
M Pharmaceutical Product Sample Retention Requirements Manufacturing and Related Processes 1
C Record retention/retrieval for 30+ years? (The lifespan of the medical device) ISO 13485:2016 - Medical Device Quality Management Systems 5
N Notification Sample Regarding Record Retention ISO 13485:2016 - Medical Device Quality Management Systems 5
CalRich Retention of First Piece from each Production Run IATF 16949 - Automotive Quality Systems Standard 11
D MSDS Datasheet Retention Requirements and Responsibilities RoHS, REACH, ELV, IMDS and Restricted Substances 6
R Retention Period requirements for DMFs (Drug Master Files) US Food and Drug Administration (FDA) 4
I Retention Time of Paint Batch Panels once Validation completed Document Control Systems, Procedures, Forms and Templates 4

Similar threads

Top Bottom