compliance activity management system w background

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COMPLIANCE ACTIVITY MANAGEMENT SYSTEMS WELCOME Relavance Software Corp

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Page 1: Compliance activity management system w background

COMPLIANCE ACTIVITY MANAGEMENT SYSTEMS

WELCOME

Relavance Software Corp

Page 2: Compliance activity management system w background

There is a Root Problem in IT:Tables are used for storing information. So what’s wrong with that? Here

is the short list...

• Tables require pre-defined specifications from known requirements and then inherently resist or block change

• But reality and requirements both change• Tables are 2 dimensional structures for storing

data• But Information is ‘n’- dimensional• Tables and columns are named by IT professionals • But Users need to get information, don’t care how

its stored, don’t have time to learn to write SQL queries themselves, and don’t want to wait for the IT pros to do it, eventually, after the SAP ERP and SCM systems, and the big data warehouse projects, are finished, installed and working.

There is a serious disconnect here: The Solution and the Requirements do not match, ...

at all.

Page 3: Compliance activity management system w background

Relavance Associative Information Systems are:

A New Paradigm for Information Storage / Management

• ‘n’-D Information Storage Model, Multi-D Management

An Associative Information Architecture• Many to Many relationship oriented architecture, holds all possible quantities and types of relationships an item (concept) may have, in all dimensions of association

Employing an active, dynamic Dendritic Network Model

• Works analogously to the brain, creating a fact based learning environment that can embody any real world info

Models all types of humanly differentiable relationships

• Every way we can think of things is intrinsically supported

Namespace, Data Structure, and Data Type independent

• All data access processing handled with Concept Tokens

Copyright 2010 - 2012, Relavance Corp. Confidential and Proprietary.

Relavance Associative Information Systems

Page 4: Compliance activity management system w background

The Relavance Associative Information Architecture::

- stores each piece of information, each concept, at the center of its own Universe of relationships,

- supports implementation of complex and rapidly changing data models and structures without redesign,

- accommodates every kind of data and information in:

• A Table-Free, Encapsulated Data Object Free, Dynamic Storage Model that can have a perfect one-to-one correspondence with the Concept model or schema of the target system or business

• A run-time Configurable, Adaptable, Evolvable Application, with unbounded extensibility

• A fully inclusive, inter-reference-able, data-type and data-source agnostic, information management platform that scales linearly with complexity and size

• A system of systems approach

Relavance Associative Information Systems

Copyright 2010 - 2012, Relavance Corp. Confidential and Proprietary.

Page 5: Compliance activity management system w background

Comparison of development cycles

Page 6: Compliance activity management system w background

ALLREGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

123321

12

6749

3

2971

2 5212

15

48137

9

2854

11

2337

8

3616

14

157

2

4497

13486793

79

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

...

Page 7: Compliance activity management system w background

ALLREGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

123321

12

6749

3

2971

2 5212

15

48137

9

2854

11

2337

8

3616

14

157

2

4497

13486793

79

COMPLIANCE DASHBOARD

......

Page 8: Compliance activity management system w background

ALLREGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

123321

12

6749

3

2971

2 5212

15

48137

9

2854

11

2337

8

3616

14

157

2

4497

13486793

79

COMPLIANCE DASHBOARD

...

Page 9: Compliance activity management system w background

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

123321

12

6749

3

2971

2 5212

15

48137

9

2854

11

2337

8

3616

14

157

2

4497

13486793

79

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

ALLREGULATIONS

ALL DEPARTMENTS

DESIGN

HR

IT

MARKETING

PRODUCTION

PURCHASING

R&D

SALES

PRODUCTION

INVENTORY

...STATUSDEPARTMENTS CONSULTANTS PRIORITYPERSONNEL

Page 10: Compliance activity management system w background

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

123321

12

6749

3

2971

2 5212

15

48137

9

2854

11

2337

8

3616

14

157

2

4497

13486793

79

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

ALL DEPARTMENTS

DESIGN

HR

IT

MARKETING

PRODUCTION

PURCHASING

R&D

SALES

ALLREGULATIONS

PRODUCTION

INVENTORY

...STATUSDEPARTMENTS CONSULTANTS PRIORITYPERSONNEL

Page 11: Compliance activity management system w background

REGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

37104

2

6749

2

2971

2 198

4

00

0

2132

7

612

3

3616

14

157

2

418

6235310

42

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

PRODUCTION

PRODUCTION

...STATUSDEPARTMENTS CONSULTANTS PRIORITYPERSONNEL

Page 12: Compliance activity management system w background

REGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

37104

2

6749

2

2971

2 198

4

00

0

2132

7

612

3

3616

14

157

2

418

6235310

42

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

PRODUCTION

PRODUCTION

...STATUSDEPARTMENTS CONSULTANTS PRIORITYPERSONNEL

Page 13: Compliance activity management system w background

REGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

37104

2

6749

2

2971

2 198

4

00

0

2132

7

612

3

3616

14

157

2

418

6235310

42

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

PRODUCTION

PRODUCTION

REGULATION AREA REGULATION ID ASSIGNED ACCOUNTABILITY

INTERNAL PROCESS ID LAST QUALIFIED TEST / DOCUMENT REFERENCE

Air Exchange Filtration / Contamination

BR-38-A-724 Prod.92.137 2011/11/28

Surface Contaminant Cleansing BR-38-W-27 Prod.6.12 2011/10/01

...STATUSDEPARTMENTS CONSULTANTS PRIORITYPERSONNEL

Page 14: Compliance activity management system w background

REGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

37104

2

6749

2

2971

2 198

4

00

0

2132

7

612

3

3616

14

157

2

418

6235310

42

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

PRODUCTION

PRODUCTION

REGULATION AREA REGULATION ID ASSIGNED ACCOUNTABILITY

INTERNAL PROCESS ID LAST QUALIFIED TEST / DOCUMENT REFERENCE

Air Exchange Filtration / Contamination

BR-38-A-724 Prod.92.137 2011/11/28

Surface Contaminant Cleansing BR-38-W-27 Prod.6.12 2011/10/01

Anne Bitmonger

ALL PERSONNEL

Billy Snarguffle

Evelyn Sneeple

Frampton Rockstar

Gary Bonecrusher

Harvey Luggage

Ivy League

Jimmy Gotcha

David Waterhead

Colin Fludgrister

PRODUCTION

...STATUSDEPARTMENTS CONSULTANTS PRIORITYPERSONNEL

Page 15: Compliance activity management system w background

REGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

37104

2

6750

1

2971

2 198

4

00

0

2132

7

612

3

3616

14

157

2

418

6235310

42

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

PRODUCTION

PRODUCTION

REGULATION AREA REGULATION ID ASSIGNED ACCOUNTABILITY

INTERNAL PROCESS ID LAST QUALIFIED TEST / DOCUMENT REFERENCE

Air Exchange Filtration / Contamination

BR-38-A-724 David Waterhead Prod.92.137 2011/11/28

Surface Contaminant Cleansing BR-38-W-27 Prod.6.12 2011/10/01

Anne Bitmonger

ALL PERSONNEL

Billy Snarguffle

Evelyn Sneeple

Frampton Rockstar

Gary Bonecrusher

Harvey Luggage

Ivy League

Jimmy Gotcha

David Waterhead

Colin Fludgrister

PRODUCTION

...STATUSDEPARTMENTS CONSULTANTS PRIORITYPERSONNEL

Page 16: Compliance activity management system w background

REGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

37104

2

6750

1

2971

2 198

4

00

0

2132

7

612

3

3616

14

157

2

418

6235310

42

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

PRODUCTION

PRODUCTION

REGULATION AREA REGULATION ID ASSIGNED ACCOUNTABILITY

INTERNAL PROCESS ID LAST QUALIFIED TEST / DOCUMENT REFERENCE

Air Exchange Filtration / Contamination

BR-38-A-724 David Waterhead Prod.92.137 2011/11/28

Surface Contaminent Cleansing BR-38-W-27 Prod.6.12 2011/10/01

Anne Bitmonger

ALL PERSONNEL

Billy Snarguffle

Evelyn Sneeple

Frampton Rockstar

Gary Bonecrusher

Harvey Luggage

Ivy League

Jimmy Gotcha

David Waterhead

Colin Fludgrister

PRODUCTION

...STATUSDEPARTMENTS CONSULTANTS PRIORITYPERSONNEL

Page 17: Compliance activity management system w background

REGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

37104

2

6751

0

2971

2 198

4

00

0

2132

7

612

3

3616

14

157

2

418

6235310

42

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

PRODUCTION

PRODUCTION

REGULATION AREA REGULATION ID ASSIGNED ACCOUNTABILITY

INTERNAL PROCESS ID LAST QUALIFIED TEST / DOCUMENT REFERENCE

Air Exchange Filtration / Contamination

BR-38-A-724 David Waterhead Prod.92.137 2011/11/28

Surface Contaminent Cleansing BR-38-W-27 Billy Snarguffle Prod.6.12 2011/10/01

Anne Bitmonger

ALL PERSONNEL

Billy Snarguffle

Evelyn Sneeple

Frampton Rockstar

Gary Bonecrusher

Harvey Luggage

Ivy League

Jimmy Gotcha

David Waterhead

Colin Fludgrister

PRODUCTION

...STATUSDEPARTMENTS CONSULTANTS PRIORITYPERSONNEL

Page 18: Compliance activity management system w background

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

REGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

37104

2

6751

0

2971

2 198

4

00

0

2132

7

612

3

3616

14

157

2

418

6235310

42

PRODUCTION

PRODUCTION

REGULATION AREA REGULATION ID ASSIGNED ACCOUNTABILITY

INTERNAL PROCESS ID LAST QUALIFIED TEST / DOCUMENT REFERENCE

Air Exchange Filtration / Contamination

BR-38-A-724 David Waterhead Prod.92.137 2011/11/28

Surface Contaminant Cleansing BR-38-W-27 Billy Snarguffle Prod.6.12 2011/10/01

...STATUSDEPARTMENTS CONSULTANTS PRIORITYPERSONNEL

Page 19: Compliance activity management system w background

REGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

37104

2

6751

0

2971

2 198

4

00

0

2132

7

612

3

3616

14

157

2

418

6235312

40

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

PRODUCTION

PRODUCTION

...STATUSDEPARTMENTS CONSULTANTS PRIORITYPERSONNEL

REF ID REGULATION ID REGULATION NAME COMPLIANCE PROCESS ID

COMPLIANCE ACTIVITIES / EVENTS

ASSIGNED Accountability Expertise REQUIRED

PRIORITY RANK

COMPLIANCE STATE

11174 BR-38-A-724 Air Exchange Filtration / Contamination

PROD.92.137 Initiative 1174 David Waterhead 4

11175 BR-38-W-27 Surface Contaminant Cleansing PROD.06.12 Initiative 1175 Billy Snarguffle 4

13812 Et cetera Et cetera Et cetera Initiative …

... Initiative

Initiative

Initiative

Initiative

Initiative

Initiative

Initiative

Initiative

Initiative

Page 20: Compliance activity management system w background

REGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

37104

2

6751

0

2971

2 198

4

00

0

2132

7

612

3

3616

14

157

2

418

6235312

40

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

PRODUCTION

REF ID REGULATION ID REGULATION NAME COMPLIANCE PROCESS ID

COMPLIANCE ACTIVITIES / EVENTS

ASSIGNED Accountability Expertise REQUIRED

PRIORITY RANK

COMPLIANCE STATE

11174 BR-38-A-724 Air Exchange Filtration / Contamination

PROD.92.137 Initiative 1174 David Waterhead 4

11175 BR-38-W-27 Surface Contaminant Cleansing PROD.06.12 Initiative 1175 Billy Snarguffle 4

13812 Et cetera Et cetera Et cetera Initiative …

... Initiative

Initiative

Initiative

Initiative

Initiative

Initiative

Initiative

Initiative

Initiative

PRODUCTION

...STATUSDEPARTMENTS CONSULTANTS PRIORITYPERSONNEL

Page 21: Compliance activity management system w background

REGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

37104

2

6751

0

2971

2 198

4

00

0

2132

7

612

3

3616

14

157

2

418

6235312

40

PRODUCTION

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

BR-38-A-724David Waterhead Gap: No Process 2012/01/27 PRODUCTION Initiative 1174

PERSONNEL ACTIVITY REGULATION STATUS DATEDEPARTMENTS

Page 22: Compliance activity management system w background

REGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

37104

2

6751

0

2971

2 198

4

00

0

2132

7

612

3

3616

14

157

2

418

6235312

40

PRODUCTION

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

BR-38-A-724David Waterhead Gap: No Process 2012/01/27 PRODUCTION Initiative 1174

PERSONNEL ACTIVITY REGULATION STATUS DATEDEPARTMENTS

Page 23: Compliance activity management system w background

David Waterhead

Initiative 1174

Gap Determined

Process Developed

Schedule Done

Training Developed

Training Done

Institute Process

Inspect & Verify

Evaluate Process

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

Proc Docs Done

Process Approved

COMPLIANCE INITIATIVE

REGULATION ID REGULATION AREA

COMPLIANCE PROCESS ID

ASSIGNED ACCOUNTABILTY

COMPLIANCE ACTIVITY DATE BEGUN DATE COMPLETE

PLANNED

Initiative 1174 BR-38-A-724 Air Exchange Filtration / Contamination

PROD.92.137 David Waterhead Schedule Initiative 2012/01/27 2012/02/03 TBC by end of March

ACTIVITY

BR-38-A-724 2012/01/27 PRODUCTION

PERSONNEL ACTIVITY REGULATION STATUS DATEDEPARTMENTS

Gap: No Process

Page 24: Compliance activity management system w background

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

COMPLIANCE INITIATIVE

REGULATION ID REGULATION AREA

COMPLIANCE PROCESS ID

ASSIGNED ACCOUNTABILTY

COMPLIANCE ACTIVITY DATE BEGUN DATE COMPLETE

PLANNED

Initiative 1174 BR-38-A-724 Air Exchange Filtration / Contamination

PROD.92.137 David Waterhead Schedule Initiative 2012/01/27 2012/02/03 TBC by end of March

Gary Bonecrusher Identify Available Process Model 2012/02/07

David Waterhead

Initiative 1174

Gap Determined

Process Developed

Schedule Done

Training Developed

Training Done

Institute Process

Inspect & Verify

Evaluate Process

Proc Docs Done

Process Approved

ACTIVITY

BR-38-A-724 Process Req’d 2012/02/02 PRODUCTION

PERSONNEL ACTIVITY REGULATION STATUS DATEDEPARTMENTS

Page 25: Compliance activity management system w background

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

COMPLIANCE INITIATIVE

REGULATION ID REGULATION AREA

COMPLIANCE PROCESS ID

ASSIGNED ACCOUNTABILTY

COMPLIANCE ACTIVITY DATE BEGUN DATE COMPLETE

PLANNED

Initiative 1174 BR-38-A-724 Air Exchange Filtration / Contamination

PROD.92.137 David Waterhead Schedule Initiative 2012/01/27 2012/02/03 TBC by end of March

Gary Bonecrusher Identify Available Process Model 2012/02/07

GAP Determined 2012/02/09 2012/02/09

PROD.92.137-A Modify Process Model 2012/02/09 2012/02/10

David Waterhead

Initiative 1174

Gap Determined

Process Developed

Schedule Done

Training Developed

Training Done

Institute Process

Inspect & Verify

Evaluate Process

Proc Docs Done

Process Approved

ACTIVITY

BR-38-A-724 Process Modified 2012/02/10 PRODUCTION

PERSONNEL ACTIVITY REGULATION STATUS DATEDEPARTMENTS

Page 26: Compliance activity management system w background

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

COMPLIANCE INITIATIVE

REGULATION ID REGULATION AREA

COMPLIANCE PROCESS ID

ASSIGNED ACCOUNTABILTY

COMPLIANCE ACTIVITY DATE BEGUN DATE COMPLETE

PLANNED

Initiative 1174 BR-38-A-724 Air Exchange Filtration / Contamination

PROD.92.137 David Waterhead Schedule Initiative 2012/01/27 2012/02/03 TBC by end of March

Gary Bonecrusher Identify Available Process Model 2012/02/07

GAP Determined 2012/02/09 2012/02/09

PROD.92.137-A Modify Process Model 2012/02/09 2012/02/10

Review with DE 2012/02/13 2012/02/13

Update Process Docs 2012/02/14 2012/02/15

Evelyn Sneeple Institute Process Training 2012/02/20 2012/02/22

Implement Process in Lab 2012/02/23 2012/02/24

David Waterhead

Initiative 1174

Gap Determined

Process Developed

Schedule Done

Training Developed

Training Done

Institute Process

Inspect & Verify

Evaluate Process

Proc Docs Done

Process Approved

ACTIVITY

BR-38-A-724PRODUCTION

PERSONNEL ACTIVITY REGULATION STATUS DATEDEPARTMENTS

Training Done 2012/02/22

Page 27: Compliance activity management system w background

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

COMPLIANCE INITIATIVE

REGULATION ID REGULATION AREA

COMPLIANCE PROCESS ID

ASSIGNED ACCOUNTABILTY

COMPLIANCE ACTIVITY DATE BEGUN DATE COMPLETE

PLANNED

Initiative 1174 BR-38-A-724 Air Exchange Filtration / Contamination

PROD.92.137 David Waterhead Schedule Initiative 2012/01/27 2012/02/03 TBC by end of March

Gary Bonecrusher Identify Available Process Model 2012/02/07

GAP Determined 2012/02/09 2012/02/09

PROD.92.137-A Modify Process Model 2012/02/09 2012/02/10

Review with DE 2012/02/13 2012/02/13

Update Process Docs 2012/02/14 2012/02/15

Evelyn Sneeple Institute Process Training 2012/02/20 2012/02/22

Implement Process in Lab 2012/02/23 2012/02/24

Inspect Process activities 2012/03/05 2012/03/05

Evaluate Process Efficacy 2012/03/07 2012/03/07

Determined Process Satisfies Regulation Req’s

2012/03/07 2012/03/07

Process Approved 2012/03/08 2012/03/08 2012/03/31

David Waterhead

Initiative 1174

Gap Determined

Process Developed

Schedule Done

Training Developed

Training Done

Institute Process

Inspect & Verify

Evaluate Process

Proc Docs Done

Process Approved

ACTIVITY

BR-38-A-724 Process Approved 2012/03/08 PRODUCTION

PERSONNEL ACTIVITY REGULATION STATUS DATEDEPARTMENTS

Page 28: Compliance activity management system w background

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

COMPLIANCE INITIATIVE

REGULATION ID REGULATION AREA

COMPLIANCE PROCESS ID

ASSIGNED ACCOUNTABILTY

COMPLIANCE ACTIVITY DATE BEGUN DATE COMPLETE

PLANNED

Initiative 1174 BR-38-A-724 Air Exchange Filtration / Contamination

PROD.92.137 David Waterhead Schedule Initiative 2012/01/27 2012/02/03 TBC by end of March

Gary Bonecrusher Identify Available Process Model 2012/02/07 2012/02/07

GAP Determined 2012/02/09 2012/02/09

PROD.92.137-A Modify Process Model 2012/02/09 2012/02/10

Review with DE 2012/02/13 2012/02/13

Update Process Docs 2012/02/14 2012/02/15

Evelyn Sneeple Institute Process Training 2012/02/20 2012/02/22

Implement Process in Lab 2012/02/23 2012/02/24

Inspect Process activities 2012/03/05 2012/03/05

Evaluate Process Efficacy 2012/03/07 2012/03/07

Determined Process Satisfies Regulation Req’s

2012/03/07 2012/03/07

Process Approved 2012/03/08 2012/03/08 2012/03/31

01/23 01/30 02/06 02/13 02/20 02/27 03/05

REGULATION ID: BR-38-A-724 - INITIATIVE 1174 - PRODUCTION DEPARTMENT - DAVID WATERHEAD

03/1201/18

Initiative Scheduled Process Model Ready Personnel Trained

Process Implemented

Inspection DoneRegulation Assigned

Process Approved

BR-38-A-724David Waterhead Process Approved 2012/03/08 PRODUCTION Initiative 1174

PERSONNEL ACTIVITY REGULATION STATUS DATEDEPARTMENTS

Page 29: Compliance activity management system w background

REGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

37104

2

6850

0

2971

2 198

4

00

0

2132

7

612

3

3616

14

157

2

418

6235312

40

PRODUCTION

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

BR-38-A-724David Waterhead Process Approved 2012/03/08 PRODUCTION Initiative 1174

PERSONNEL ACTIVITY REGULATION STATUS DATEDEPARTMENTS

01/23 01/30 02/06 02/13 02/20 02/27 03/05

BIO RISK REGULATION ID: BR-38-A-724 - INITIATIVE 1174 - PRODUCTION DEPARTMENT - DAVID WATERHEAD

03/1201/18

Initiative Scheduled Process Model Ready Personnel Trained

Process Implemented

Inspection DoneRegulation Assigned

Process Approved

Page 30: Compliance activity management system w background

REGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

37104

2

6751

0

2971

2 198

4

00

0

2132

7

612

3

3616

14

157

2

418

6235312

40

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

DEPARTMENTS PERSONNEL

PRODUCTION

PRODUCTION

CONSULTANTS PRIORITY STATUS ...

Page 31: Compliance activity management system w background

REGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

37104

2

6751

0

2971

2 198

4

00

0

2132

7

612

3

3616

14

157

2

418

6235312

40

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

DEPARTMENTS PERSONNEL

PRODUCTION

PRODUCTION

CONSULTANTS PRIORITY STATUS ...

Status Bubbles

ALL CONTROLS

Grid 1

Grid 3

Grid 2

Dropdown 1

Dropdown 2

Dropdown 3

Dropdown 4

Dropdown 5

Dropdown 6

...

Page 32: Compliance activity management system w background

REGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

37104

2

6751

0

2971

2 198

4

00

0

2132

7

612

3

3616

14

157

2

418

6235312

40

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

DEPARTMENTS PERSONNEL

PRODUCTION

PRODUCTION

CONSULTANTS PRIORITY STATUS ...

Status Bubbles

COMPLIANCE REFERENCE CONTEXTS Status 1 Status 2 Status 3

Ref ID x x

REGULATION ID x x x

REGULATION AREA x x x

COMPLIANCE PROCESS ID x x

COMPLIANCE ACTIVITIES / EVENTS x x

ASSIGNED Accountability x x x

Expertise area x x

PRIORITY RANK x x

COMPLIANCE STATE x x

DATE BEGUN x

DATE COMPLETED x

COMPLIANCE Initiative ID

PLANNED / Scheduled

PROGRAM / PROCESS IDENTIFIED

PROGRAM / PROCESS DEVELOPED

PROGRAM / PROCESS DOCUMENTATION DONE

PROGRAM / PROCESS TRAINING DEVELOPED

TRAINING DONE

PROGRAM / PROCESS INSTITUTED

COMPLIANCE INSPECTION COMPLETED

PROGRAM / PROCESS EVALUATION COMPLETED

PROGRAM / PROCESS APPROVED

Page 33: Compliance activity management system w background

REGULATIONS

ENVIRONMENTAL

PUBLICSAFETY

PUBLICHEALTH

SOURCE MATERIALS

ELECTRONICRECORDS

BIO-RISK

BIO-HAZARD

CORPORATEGOVERNANCE

ACCOUNTING

EMPLOYEESAFETY

37104

2

6751

0

2971

2 198

4

00

0

2132

7

612

3

3616

14

157

2

418

6235312

40

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM

DEPARTMENTS PERSONNEL

PRODUCTION

PRODUCTION

CONSULTANTS PRIORITY STATUS ...

Status Bubbles

COMPLIANCE REFERENCE CONTEXTS Status 1 Status 2 Status 3

Ref ID x

REGULATION ID x x x

REGULATION AREA x x x

COMPLIANCE PROCESS ID x x

COMPLIANCE ACTIVITIES / EVENTS x x

ASSIGNED Accountability x x x

Expertise area x x

PRIORITY RANK x x

COMPLIANCE STATE x x

DATE BEGUN x x

DATE COMPLETED x x

COMPLIANCE Initiative ID x

PLANNED / Scheduled x

PROGRAM / PROCESS IDENTIFIED

PROGRAM / PROCESS DEVELOPED

PROGRAM / PROCESS DOCUMENTATION DONE

PROGRAM / PROCESS TRAINING DEVELOPED

TRAINING DONE

PROGRAM / PROCESS INSTITUTED

COMPLIANCE INSPECTION COMPLETED

PROGRAM / PROCESS EVALUATION COMPLETED

PROGRAM / PROCESS APPROVED

Page 34: Compliance activity management system w background

COMPLIANCE ACTIVITY MANAGEMENT SYSTEM