{"text_format":"1","workbook":"xlsx","n_sheets":6,"sheets":["Cover ","Instructions","Tool","Other Considerations","Tool References","Version Control"],"not_rendered":{"charts":0,"images":0,"macros":1,"external_links":0,"defined_names":4,"comments":0,"pivot_tables":0},"unopened":[],"bounds":{"document_bytes":16777216,"sheet_cells":100000,"rows_first":2000,"rows_last":500,"rows_between":2000,"halvings":0,"cell_chars":16384,"cell_head_chars":4096},"cells_cut":0,"cells_raw":0,"read":"whole","date_system":"1900"}

{"sheet":"Cover ","index":0,"n_rows":26,"n_cols":3,"rows_kept":26,"cut":false,"hidden":false,"merged":[]}
[]
[]
[null,"DYNOVELOCITY "]
[null,"CSV EQUIPMENT RISK ASSESSMENT TOOL"]
[null,"VERSION 1.1"]
[]
[]
["Client:"]
["System Name:"]
["System Number:"]
["System Location:"]
[]
["Total System Score:",{"$f":"Tool!A1","v":7}]
["System Risk:     ",{"$f":"IF(B13<=70,\"Low\",IF(B13<=140,\"Moderate\",IF(B13>=141,\"High\")))","v":"Low"}]
[]
["Other Considerations Score (if applicable):",{"$f":"'Other Considerations'!A1","v":2}]
[" Considerations Risk:",{"$f":"IF(B16<=20,\"Low\",IF(B16<=40,\"Moderate\",IF(B16>=41,\"High\")))","v":"Low"}]
[]
["Performed By (printed name):"]
["Performed By (signature and date):"]
[]
["System Owner (printed name):"]
["System Owner Reviewed (signature and date):"]
[]
["Quality Unit (printed name):",null," "]
["Quality Unit Reviewed (signature and date):"]

{"sheet":"Instructions","index":1,"n_rows":25,"n_cols":1,"rows_kept":25,"cut":false,"hidden":false,"merged":[]}
[]
[]
["DYNOVELOCITY "]
["CSV EQUIPMENT RISK ASSESSMENT TOOL"]
["VERSION 1.1"]
["Tool created by: Mary Jo Egbert of DynoVelocity.  Inspired by Roche Pharmaceuticals 2005 v1.2 SRA Tool.  "]
[]
["INSTRUCTIONS:"]
["1.  Must use Microsoft EXCEL 2010 or Higher for PC.  Excel 2011 or Higher for Mac. Earlier versions of Excel may not display lists properly."]
["2. Type in relevant information on cover page."]
["3. Select Tool Tab:"]
["     a. Respond to each risk issue question by clicking then selecting an answer from the drop down menu in the answer column (D.)"]
["     b. Clicking on a cell will result in a yellow shading for tracking purposes.  To remove shading right click."]
["     c. The total system score (A1) will automatically update as selections are made."]
["     d. The total system score will automatically update on cover page, assigning a system risk."]
["     e. Save."]
["4.  Complete other considerations (if applicable):"]
["     a. Select Other Considerations Tab."]
["     b. Respond to each consideration question by clicking then selecting an answer from the drop down menu in the answer column (D.)"]
["     c.  Clicking on a cell will result in a yellow shading for tracking purposes.  To remove shading right click."]
["     d. The total consideration score (A1) will automatically update as selections are made."]
["     e. The total consideration score will automatically update on cover page, assigning a considerations risk."]
["     f.  Save."]
["5.  Upon completion, sign name and enter sign off date on cover page."]
["6.  Obtain appropriate approval-reviewers signatures (reviewers sign name and enter sign off date) on cover page."]

{"sheet":"Tool","index":2,"n_rows":30,"n_cols":5,"rows_kept":30,"cut":false,"hidden":false,"merged":[]}
[{"$f":"SUM(E5:E37)","v":7},"Total System Score",{"$f":"NOW()","v":"2014-09-30T16:06:00.480"}]
[]
[]
["Type of Risk","Category","Risk Issue Question","Answer (select from drop down)","Scores"]
[]
["Safety Risk","Patient ","Will malfunction of the system result in harm to the patient?","No Harm",{"$f":"VLOOKUP(D6,Table2[],2,FALSE)","v":0}]
[null,"Employee Harm","Will malfunction of the system result in harm to employees?","No Harm",{"$f":"VLOOKUP(D7,Table2[],2,FALSE)","v":0}]
[null,"Facility","Will malfunction of the system result in damage to the facility?","No Damage",{"$f":"VLOOKUP(D8,'Tool References'!A9:B12,2,FALSE)","v":0}]
[]
["Compliance Risk","Business Process Regulation","Is the business process regulated by an agency (ex: FDA-GxP)?","No",{"$f":"VLOOKUP(D10,'Tool References'!A15:B16,2,FALSE)","v":0}]
[null,"Degree of Exposure","Are data or records made available to regulatory agencies?","No",{"$f":"VLOOKUP(D11,'Tool References'!A15:B16,2,FALSE)","v":0}]
[null,"Complexity of Regulations","Does Part 11, SOX or other specific regulatory requirements apply to the system?","No",{"$f":"VLOOKUP(D12,'Tool References'!A15:B16,2,FALSE)","v":0}]
[]
["Business Risk","Number of users","Estimate number of users on the system.",1,{"$f":"VLOOKUP(D14,'Tool References'!A19:B22,2,FALSE)","v":1}]
[null,"Frequency of usage","Estimate how frequently users operate or interface with the system.","Yearly or longer",{"$f":"VLOOKUP(D15,'Tool References'!A24:B27,2,FALSE)","v":1}]
[null,"Location- Scale of System","At how many locations is the system utilized?","One U.S. Site",{"$f":"VLOOKUP(D16,'Tool References'!A30:B32,2,FALSE)","v":1}]
[null,"Criticality of Business System","Can business continue to operate if the system fails?","Yes, with an alternative system",{"$f":"VLOOKUP(D17,'Tool References'!A35:B38,2,FALSE)","v":0}]
[null,"Criticality of Records contained in system","Is this system the sole source of data for the business process?","No",{"$f":"VLOOKUP(D18,'Tool References'!A41:B42,2,FALSE)","v":0}]
[null,"Cross Organizational boundaries","Does critical data go to other departments and/or processes?","No",{"$f":"VLOOKUP(D19,'Tool References'!A41:B42,2,FALSE)","v":0}]
[]
["Technology Risk","Age","What is the age-maturity (aka version) of this specific technology as stated by vendor?","Mature Technology",{"$f":"VLOOKUP(D21,'Tool References'!A45:B48,2,FALSE)","v":2}]
[null,"Experience","What is our company's experience with this specific technology?","Mature Technology previously used by our company",{"$f":"VLOOKUP(D22,'Tool References'!A51:B54,2,FALSE)","v":2}]
[null,"Associated Systems","Does system rely on the internet?","No",{"$f":"VLOOKUP(D23,'Tool References'!A57:B58,2,FALSE)","v":0}]
[null,"Associated Systems","How many technology enablers are interfaced to the system?","1 - Internet only",{"$f":"VLOOKUP(D24,'Tool References'!A61:B64,2,FALSE)","v":0}]
[null,"System Categorization","What is the technology category (ex: GAMP) for the system?","Non-Automated (mechanical only)",{"$f":"VLOOKUP(D25,'Tool References'!A67:B71,2,FALSE)","v":0}]
[]
["Security Risk","Physical Security","Is the system physically secured by badge, key or lockpad combination access?","Yes",{"$f":"VLOOKUP(D27,'Tool References'!A74:B75,2,FALSE)","v":0}]
[null,"Logical Security","Is the system secured by network login?","Yes",{"$f":"VLOOKUP(D28,'Tool References'!A78:B80,2,FALSE)","v":0}]
[null,"Logical Security","Is the system secured by application and/or windows login?","Yes",{"$f":"VLOOKUP(D29,'Tool References'!A78:B80,2,FALSE)","v":0}]
[null,"Data Security","Is data stored in a secure location available only to authorized users?","Yes",{"$f":"VLOOKUP(D30,'Tool References'!A83:B86,2,FALSE)","v":0}]

{"sheet":"Other Considerations","index":3,"n_rows":16,"n_cols":5,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[{"$f":"SUM(E6:E17)","v":2},"Total Consideration Score",{"$f":"NOW()","v":"2014-09-30T16:06:00.480"}]
[]
[]
["Type of Challenge","Category","Consider the Question","Answer (select from drop down)","Score"]
[]
["Operational Pitfalls","Product loss","Will malfunction of the system result in product loss or slow production?","No",{"$f":"VLOOKUP(D6,'Tool References'!A89:B91,2,FALSE)","v":0}]
[null,"Labor loss","Will malfunction of the system result in additional employee labor?","No",{"$f":"VLOOKUP(D7,'Tool References'!A89:B91,2,FALSE)","v":0}]
[null,"Equipment loss","What is the approximate cost to repair system in U.S. dollars?","Less than 25k",{"$f":"VLOOKUP(D8,'Tool References'!A94:B98,2,FALSE)","v":1}]
[null,"Equipment loss","What is the approximate cost to replace system in U.S. dollars?","Less than 25k",{"$f":"VLOOKUP(D9,'Tool References'!A94:B98,2,FALSE)","v":1}]
[null,"Regulatory Impact","Will malfunction of the system result in external investigations?","No",{"$f":"VLOOKUP(D10,'Tool References'!A101:B102,2,FALSE)","v":0}]
[null,"Level of Exposure","Will malfunction of the system result in public embarassment to company?","No",{"$f":"VLOOKUP(D11,'Tool References'!A101:B102,2,FALSE)","v":0}]
[]
[]
[]
[]
[null,null," "]

{"sheet":"Tool References","index":4,"n_rows":102,"n_cols":4,"rows_kept":102,"cut":false,"hidden":true,"merged":[]}
[]
["Result","Impact",null,"Safety: Employee, Patient"]
["No Harm",0]
["Minor Injury",4]
["Major Injury",6]
["Death",10]
[]
["Result","Impact"]
["No Damage",0,null,"Safety: Facility"]
["Minor Damage",4]
["Major Damage",6]
["Disaster- Government Required for re-entry",10]
[]
["Answer","Impact",null,"Compliance: all"]
["No",0]
["Yes",10]
[]
["Answer","Impact",null,"Business:  # of users"]
[1,1]
["2 to 35",3]
["35 to 150",7]
["more than 150",10]
[]
["Yearly or longer",1,null,"Business:  Frequency"]
["Every 6 months",3]
["Monthly",7]
["Daily",10]
[]
["Answer","Impact",null,"Business: Sites"]
["One U.S. Site",1]
["Multiple U.S. Sites",5]
["Multiple Global Sites",10]
[]
["Answer","Impact",null,"Business: System Failure"]
["Yes, with an alternative system",0]
["Yes, upon this system's restore",2]
["Yes, with a manual procedure",6]
["No backup, alternative or manual procedure",10]
[]
["Answer","Impact",null,"Business: Sole Source, Other Depts."]
["No",0]
["Yes",10]
[]
["Answer","Impact",null,"Technology:  Age"]
["Mature Technology",2]
["Newer Technology ",7]
["Brand New- First Release",10]
["Approaching Obselete Technology",10]
[]
["Answer","Impact",null,"Technology:  Co. Experience"]
["Mature Technology previously used by our company",2]
["Mature Technology never used by our company",4]
["Approaching Obselete",6]
["New to company",10]
[]
["Answer","Impact",null,"Technology:  Internet"]
["No",0]
["Yes",10]
[]
["Answer","Impact",null,"Technology:  Enablers"]
["1 - Internet only",0]
["1 - Other than internet",4]
["2 to 3",6]
["More than 3",10]
[]
["Answer","Impact",null,"Technology:  System Categorization"]
["Non-Automated (mechanical only)",0]
["Semi-Automated",3]
["COTS Software (Commerical off the shelf)",5]
["Configurable Software",7]
["Custom Software",10]
[]
["Answer","Impact",null,"Security:  Physical"]
["Yes",0]
["No",10]
[]
["Answer","Impact",null,"Security:  Network, Application"]
["Yes",0]
["NA-Non or semi automated",0]
["No",10]
[]
["Answer","Impact",null,"Security:  Data"]
["Yes",0]
["NA-Non or semi automated",0]
["NA-No data produced ",0]
["No",10]
[]
["Answer","Impact",null,"Operational: product, labor"]
["No",0]
["Yes - Minor",5]
["Yes - Major",10]
[]
["Answer","Impact",null,"Equipment: Cost of Repair, Replacement"]
["Less than 25k",1]
["25k -100k",3]
["100k - 500k",5]
["500k - 1 million",7]
["Greater than 1 million",10]
[]
["Answer","Impact",null,"Ops: Regulartory, Exposure"]
["No",0]
["Yes ",10]

{"sheet":"Version Control","index":5,"n_rows":14,"n_cols":3,"rows_kept":14,"cut":false,"hidden":true,"merged":[]}
[null,"DYNOVELOCITY "]
[null,"CSV EQUIPMENT RISK ASSESSMENT TOOL"]
[]
[]
["Version","Description of Change and Reason","Effective upon Release"]
[]
[1,"N/A- Initial Release","2014-09-16"]
[]
[1.1000000000000001,"Removed period from row 17 drop down menu on Tool page.  Reason: Typo","2014-09-30"]
[null,"Unshaded \"Risk Issue Question\" on Tool page.  Reason: Update sheet design."]
[null,"Unshaded \"Consider the Question\" on Other Considerations page.  Reason: Update sheet design."]
[null,"Removed Bob and Justin as reviewers on instructions tab.  Reason: Posting to public forum."]
[null,"Added version control.  Reason: Industry Best Practice."]
[null,"Set print area on Tool and Other Considerations page for box only (excludes row 1.)  Reason:  Avoids confusion during multiple in progress print outs."]