SQM - FDA Software Regulation and Validation and Risk Management and 21 CFR Part 11

ID	Task Name	Duration
1	Design and Development Plan (DDP) [820.30(b)]	xx days
2	Responsibility for Generating / Writing DDP	xx days
3	Responsibility for Reviewing DDP	xx days
4	Responsibility for Approving DDP	xx days
5	Design and Development Plan Complete	xx days
6	Responsibility for modifying DDP (if needed)	xx days
7	Responsibility for ensuring compliance to DDP	xx days
8	Define overall responsibility for Design Review(s) Coordination G	xx days
9	Define overall responsibility for Design Verification Coordination G	xx days
10	Define overall responsibility for Design Validation Coordination IS, G	xx days
11	General [820.30(a)] IS	xx days
12	Reference procedure(s)	xx days
13	Assessing New Product Ideas __________ G	xx days
14	Training and retraining of design managers and design staff __________ G	xx days
15	Use of Consultants __________ G	xx days
16	Evaluation of the design process __________ G	xx days
17	Product evaluation, including third party product certification and approvals __________ G	xx days
18	Patenting or other means of design protections __________ G	xx days
19	Goals and Objectives G	xx days
20	Check what is to be developed G	xx days
21	___ Hardware (Catalog # _____ Revision _____) G	xx days
22	___ Software (Catalog # _____ Version _____) G	xx days
23	___ Services (Catalog # _____ Revision _____) G	xx days
24	___ Processed Materials (Catalog # _____ Revision _____) G	xx days
25	___ Manufacturing Processes (Catalog # _____ Revision _____) G	xx days
26	___ Quality System Equipment (Catalog # _____ Revision _____)	xx days
27	Submission Requirements	xx days
28	___ Check if new submission required, Reference # __	xx days
29	___ Check if Letter to File required, Reference # __	xx days
30	___ Check if no regulatory action required (exempt)	xx days
31	Reference original 510(k) Number ______________	xx days
32	Reference original PMA Number _________________	xx days
33	Check device classification R	xx days
34	____ Check if class I R	xx days
35	____ Check if device is automated with computer software R	xx days
36	____ Check if class II R	xx days
37	____ Check if class III R	xx days
38	____ Check if exempt from Design Controls	xx days
39	State rationale, Reference # ___	xx days
40	Design Control Product Overview	xx days
41	____ Check if original design (including any changes after 6/1/97) IS	xx days
42	If initiated prior to 6/1/97, state date design effort was initiated ________ IS	xx days
43	____ Check if modification to existing design (any changes after 6/1/97) IS	xx days
44	If initiated prior to 6/1/97, state date design effort was initiated __________ IS	xx days
45	Identify at what stage in the design & development effort design controls were applied ___________ IS	xx days
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