P
Peterseb
Hi,
thanks for a wonderful source of information! Sorry for writing a very long post.
I work with a medical device company that has a paper-based quality management system that will complies with the requirements of ISO 13485 (and most likely 21 CFR 820 later).
I would like to know what best practices are in terms of handling documents that turn into records, more specifically, test plans or validation plans that first is a document/specification and when filled in turns to records. This is how we do today:
A Document control SOP dictates templates, review and approvals, doc ID, etc. Documents are generally given a number based on initials and date, for example jdo20091228-1 (SOPs and drawings have their own numbering schemes). A test or validation plan would fall into this category. A test engineer would issue the document with a number like above, specify requirements to be tested, acceptance criteria, test method, environment, equipment etc. On the last pages, he/she would create tables or similar appropriate for filling in test results.
The document would be reviewed, approved, signed and dated.
Records are handled according to a Control of records SOP which dictates templates, doc ID etc. All record types are identified in a record master list, for example Change requests, non-conformities, receiving inspection records, management review records, design review records. Each record type has its own acronym, such as CR for Change Request and NC for Non-Conformity. Each record type also has its own ledger, from which they are given a unique identifier based on the acronym, such as CR-002, or NC-095.
When testing, the approved document jdo20091228-1 would be copied, and the test results filled in. When completed a number would be taken from the test engineer from the Verification record ledger, VR-005. The number would be written on the top right corner of the record (which still contains the header from being a document with issued by, reviewed by, approved by fields).
The completed verification record would be filed in a binder with the other verification records.
Please give me feedback the approach above is appropriate? If there are other easier/better ways? What is the typical set up for this that would be recognized by auditors?
Thanks in advance,
Peter
thanks for a wonderful source of information! Sorry for writing a very long post.
I work with a medical device company that has a paper-based quality management system that will complies with the requirements of ISO 13485 (and most likely 21 CFR 820 later).
I would like to know what best practices are in terms of handling documents that turn into records, more specifically, test plans or validation plans that first is a document/specification and when filled in turns to records. This is how we do today:
A Document control SOP dictates templates, review and approvals, doc ID, etc. Documents are generally given a number based on initials and date, for example jdo20091228-1 (SOPs and drawings have their own numbering schemes). A test or validation plan would fall into this category. A test engineer would issue the document with a number like above, specify requirements to be tested, acceptance criteria, test method, environment, equipment etc. On the last pages, he/she would create tables or similar appropriate for filling in test results.
The document would be reviewed, approved, signed and dated.
Records are handled according to a Control of records SOP which dictates templates, doc ID etc. All record types are identified in a record master list, for example Change requests, non-conformities, receiving inspection records, management review records, design review records. Each record type has its own acronym, such as CR for Change Request and NC for Non-Conformity. Each record type also has its own ledger, from which they are given a unique identifier based on the acronym, such as CR-002, or NC-095.
When testing, the approved document jdo20091228-1 would be copied, and the test results filled in. When completed a number would be taken from the test engineer from the Verification record ledger, VR-005. The number would be written on the top right corner of the record (which still contains the header from being a document with issued by, reviewed by, approved by fields).
The completed verification record would be filed in a binder with the other verification records.
Please give me feedback the approach above is appropriate? If there are other easier/better ways? What is the typical set up for this that would be recognized by auditors?
Thanks in advance,
Peter
I am sorry this question didn't get a response earlier. 
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