Medtronic Controlled Information This document/record is electronically controlled; printed copies are considered uncontrolled. System of Record: Medtronic Records Control System (MRCS) Identifier Version Author Moon, Darci 11-May-2015 16:08 UTC APPROVALS Effective Not Applicable Signed by Date/Time (UTC) Meaning of Signature Branch, Michael 06-May-2015 19:07 Global IT QA Lead Branch, Michael 06-May-2015 19:20 Manager Eickhof, Le Anne 11-May-2015 16:08 Quality Group Moon, Darci 06-May-2015 19:09 Author
Document History The history table shows recent change descriptions. Change descriptions for previous versions are available in previously retained versions of this document. Revision Reason/Description Moved contents of 103245-SOP Document Review SOP into this SOP: Section 7 added to contain the Document Review procedure. Scope, Purpose, Responsibilities and Abbreviation sections edited to include review information. The term significant changes is changed in 3 places to changes since the term significant was unclear. Other Process Improvements: References Section: updated title for 70654-SOP (and updated this text/reference throughout the document). Removed reference to 103245-SOP. Abbreviations Section: clarified that Document and Record mean the same thing for this SOP. Removed responsibilities from the definition of Approval. Responsibilities Section: Revised Approver responsibilities to incorporate the concept of area of expertise. 6.2.1 Required Elements: moved version to be included with unique identifier, clarifying that unique identifier can be made up for one or more items. 6.3 Minimum Required Approver table: For Quality Records changed SABA to Learning Management System. 6.3: aligned Approver bullet with revised responsibilities. 6.3 (due to internal audit finding), o edited bullet regarding embedded files and links to state that those items are not to be used in approved records. o Added bullet to state records and attachments (such as to PRs) must be viewable (do not use password protection which limits viewability or protected zip files). 6.6: clarified that completed (rather than approved) changes are made available to users. 6.12: minor edits for clarity. Deliverables: simplified by removing redundant information. 7.0 This version is approved in the Webtop version of MRCS. Updates made to support use of both the Webtop (legacy) and D2 (new) interfaces to MRCS documentum. This includes: Clarifying that quality records are effective upon approval but process documents are effective when status is set to effective. Revising language regarding first approved version numbers (Webtop=2.0; D2=1.0) Guidance and template/form minimum approvers described in more detail. Clarified QMS Process Documents means Policy, SOP, WI and Template documents. Business Process Documents are newly described for informational purposes but are not in scope of this SOP. Security section removes the requirement to state Medtronic Confidential on controlled documents and adds the requirement to follow 91249-InfoSec-IC for labeling documents. As a result, changed footer label to Medtronic Controlled. Moved wet ink and document format & content components of 87275-WI Document Control to this SOP. 87275-WI will be obsoleted. Added reference to 86922-SOP Training SOP. Deleted author column from history table. Validated document repository tracks author Global IT Quality Management System Page 1 of 18
Table of Contents 1. Scope 3 2. Purpose 3 3. References 3 4. Abbreviations, Acronyms, and Definitions 4 5. Responsibilities 5 6. Document Control 6 6.1. Quality Pyramid 6 6.2. Record Format and Contents 7 6.3. Document Approval 9 6.4. Communication of Document Effectivity 11 6.5. Control of Documentation 11 6.6. Document Version Control 11 6.7. Obsolete Documentation 12 6.8. Email 12 6.9. Retention 12 6.10. Electronic Signature and Electronic Records 12 6.11. Paper Quality Records 13 6.12. Document Security 13 6.13. Legacy Documentation 13 7. Document Review 14 7.1. Process Document Review 14 7.2. Quality Record Review 17 8. Deliverables 18 9. Approvals 18 Global IT Quality Management System Page 2 of 18
1. Scope Global IT Document Control SOP pertains to all organizations governed by the Global Technology Council (GTC). This SOP applies to Quality Management System process documentation and quality records, both paper and electronic. This process applies to authors and approvers (reviewers) of a Quality Management System (QMS) document that is either required, or is needed by the Global IT organization to ensure the effective planning, operation and control of processes. This document does not pertain to business process documentation. 2. Purpose This SOP defines the document control procedure and describes the minimum requirements for control of Quality Management System process documentation and quality records which are produced to demonstrate compliance to applicable regulatory and corporate requirements. Additionally, this SOP defines document review and describes review requirements to ensure QMS documents are up to date, correct, readable and available. 3. References Reference ID Quality 21 CFR 820, 210, 211, and 11 Document of External Origin (Y/N) 1 Y Title or Document Description Quality Regulations ISO 13485 Y Quality Management Systems Requirements for regulatory purposes Corporate-007 N Electronic Records and Signatures Corporate-028 N Quality Records and Document Control Policy 70654-SOP N Records & Information Management Retention Schedule 87055-P N Global IT Quality Management System Manual 86922-SOP N Global IT Training Procedure SOP 128952-GD N Global IT QMS Document Author Checklist Guidance 131658-GD N Global IT Quality Record Checklist Guidance 91249-InfoSec-IC N Information Risk Management Standard Document of External Origin is required by the Corporate Global Policy (028 Quality Records and Document Control Policy) Document of External Origin: A document that originates from outside the organization and contains specific information that the organization needs to fulfill customer requirements, maintain their quality management system (QMS) or comply with statutes. Examples: National / International Standards (ISO, ASTM, etc.), Customer specifications, Industry and product standards (ex. clean room standards), Statutory and regulatory requirements, Operating and repair manuals needed to use/maintain equipment Global IT Quality Management System Page 3 of 18
4. Abbreviations, Acronyms, and Definitions Term Approval Controlled Document Document Guidance ITIL Obsolete Document OLA Process Documents Policy QMS Quality Records Quality Record Integrity Reference Document Review Signature SLA Definition Signature and date of the individual(s) approving the entry, entries or document(s), whether by paper or electronic means. Approval occurs prior to issuance. A document (paper or electronic) under change control where each version, revision level or iteration is uniquely identified. Refers to process documents or quality records. Note the terms Document and Record have the same meaning in this SOP. Documents that are not required but may be created to enhance productivity and facilitate training. Information Technology Infrastructure Library Documents that are no longer in effect. Obsolete documents do not get further revisions. OLA (ITIL): An agreement between an IT service provider and another part of the same organization. It supports the IT service provider s delivery of IT services to customers and defines the goods or services to be provided and the responsibilities of both parties. QMS Process Documents: Policy, SOP, Work Instruction, Guidance and Form/Template documents (the subject of this SOP). Business Process Documents: documents not fulfilling QMS requirements (not the subject of this SOP) A Policy communicates an organization s overall intentions and direction. It defines high-level compliance and business requirements. Quality Management System Paper or electronic evidence stating results achieved or providing evidence of activities performed. Quality records are used to demonstrate conformance to applicable regulation(s) and other specified requirements and the operation of systems and processes. Quality records require control to maintain integrity and ensure accuracy for the required retention period of the record. The reliability and correctness of the record; a condition that exists as long as accidental or intentional destruction, alteration, or loss of data in the record does not occur. Any document that either constrains or supports a document s content (e.g. external standards or other closely related internal documents). Informal process of soliciting input from reviewers, SMEs and other affected parties. The purpose is to ensure correctness, completeness and to understand impacts. The review process is fluid, dynamic, iterative and flexible. Evidence of interim review activity is not required because the final approved document represents a culmination of all review input. One s name as written by oneself used to identify the person signing a document. An electronic signature is the electronic equivalent to a hand written signature. SLA (ITIL): An agreement between an IT service provider and a customer. A service level agreement describes the IT service, documents service level targets, and specifies the responsibilities of the IT service provider and the customer. Global IT Quality Management System Page 4 of 18
Term SOP SME Stored Record Template / Form Wet Ink WI Definition A Standard Operating Procedure (SOP) defines the organization s key processes used to comply with a Policy. An SOP identifies what is to be done, who will do it, when it will be done, what inputs or supporting documents are required, and what outputs are produced. Subject Matter Expert 5. Responsibilities Role Author Approver Global IT Quality System Representative Records that do not have an approval cycle and are not approved. These records do not need to demonstrate conformance to applicable regulation(s) and other specified requirements and the operation of systems and processes. Document used to standardize the collection or presentation of information. The scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate writing in a permanent form. The act of signing, with a pen or writing instrument. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark. A Work Instruction provides a detailed breakdown of instructions required to carry out one or more steps or tasks from a procedure. A Work Instruction is created when attention and precision to detail is required. Responsibilities Responsible for creating, revising, and obsoleting documents retaining documents correctly (appropriate physical file for paper records or a validated document / record repository for electronic records) accurate document content and format accuracy within the context of a validated document repository (for electronically controlled documents) assigning approvers of the document and obtaining their approvals QMS process document authors are additionally responsible for periodic document review. Person who applies an approval to a record and is accountable for the integrity of the entire record. Approvers are responsible for reviewing the entire record: with emphasis on their area of expertise and for completeness, correctness, adequacy, and correct retention Individual from Global IT Quality Compliance Management team. Reviews quality aspects of documents, when required. Approves documents prior to issue. Sets process document status to effective if needed. Ensures process documents are available on the Global IT Quality Management System web site. Global IT Quality Management System Page 5 of 18
Role Reviewer or Subject Matter Expert (SME) Responsibilities Individuals that: use the process or document, are responsible for input into the process / document Utilize the output from the process / document. These individuals will review the document to ensure no negative impact from any changes. All reviewers do not necessarily approve a document. They may be added as an approver of the document. 6. Document Control 6.1.Quality Pyramid The types of documents under document control of the Global IT Quality Management System are identified in the following Quality System Pyramid. Global IT Quality Management System documents are maintained and controlled in a validated document/record repository or physical file for paper records. The quality pyramid identifies relationships between the different types of documents. Documents at a lower level implement upper level documents. Procedures may be supported by Work Instructions. Some Procedures may provide enough detail that an additional Work Instruction is not necessary. Templates or Forms may be provided as part of a Procedure or Work Instruction to further control how data is collected or presented. Procedures or Work Instructions define any quality record that results from carrying out the actions therein, as applicable. Quality records demonstrate conformance to applicable regulation(s) and other specified requirements and the operation of systems and processes. Global IT Quality Management System Page 6 of 18
Quality records are maintained and controlled in a validated document/record repository or a physical file for paper records. 6.2.Record Format and Contents This section pertains to both process and quality record documents. Documents that were created and approved prior to this Procedure s current version will be maintained in their current format until their next revision. 6.2.1. Required Elements records must contain: a) unique identifier ( name, number, version or any combination of these items) b) title c) page number(s) d) approval information including meaning of signature, date and signature e) history of changes to approved versions including a change description. Note: changes to quality records are effective upon approval. Changes to process documents are effective when the document status is set to effective. 6.2.2. Recommended Common Elements The following provides guidance on record format and contents but does not describe required elements. All sections described below may not apply to all records. 6.2.2.1. Scope Process Documents: The scope section is intended to help readers understand if the document pertains to them or their work. Describe the criteria or group that is associated with the document. Include organizational scope language such as in the following example, This document pertains to all organizations governed by the Global Technology Council (GTC). Quality Records: The scope section clarifies the extent of the subject matter the record applies to such as a system version, project or event. 6.2.2.2. Purpose Process Documents: The purpose section includes information on how to plan, operate and control processes. Example: To describe the process adopted by Global IT Infrastructure to manage the implementation of changes in the production environment. Quality Records: The purpose section specifies the reason the record exists. This could include describing what process is being fulfilled, or the objectives of the record. 6.2.2.3. References List the Reference ID and Title / Description of any document that either constrains or supports a document s content. This includes external standards or other closely related internal documents. Reference table example: Global IT Quality Management System Page 7 of 18
Reference ID ISO 13485; Second edition; 2003-07-15 Document of External Origin (Y/N) 1 Y Title or Document Description Quality Management Systems Requirements for regulatory purposes 87055-P N Global IT Quality Management System Manual 1 Document of External Origin notation is required by the Corporate Global Policy (028 Quality Records and Document Control Policy) 6.2.2.4. Abbreviations, Acronyms, and Definitions List terminology used in the document content that is not commonly used or understood, or will assist in the understanding of the document. 6.2.2.5. Responsibilities Process Documents: List the roles responsible for conducting the work described in the document. For each role, provide a summary of their responsibilities. Quality Records: This section is typically used in plans. 6.2.2.6. Policy, SOP, WI, Record Content Process Documents: Document the process details in this section. Include diagrams or flowcharts as appropriate. It is permissible to use appendices for clarifying information. Deliverables generated are described. Quality Records: Document the record details in this section. The record content is based on the purpose and scope of the record. 6.2.2.7. Deliverables Process Documents: List any outputs that are a result of executing the process or demonstrate compliance with the process. List a description of the record and the record retention code as specified in the 70654-SOP. Quality Records: This section is typically used in plans and reports. 6.2.2.8. Document History Document History begins with the first approved version number. The Reason/Description can be defaulted to Version. The history should be updated for each approved revision. Enter the reason for and description of the revision. If a date is listed for a particular version, it indicates the date the author completed updates prior to routing for approval. Global IT Quality Management System Page 8 of 18
6.2.2.9. Approvals For electronically approved documents, the approval section can reference the validated document repository for author and approver names and roles. Examples of suitable language include: Signing constitutes applying an approval signature prior to issuance. This approval indicates that the approver has reviewed the document and finds it to be adequate, complete and correct. Approvals of this document are maintained using the e-signature functionality of the validated document repository. 6.2.2.10. Header and Footer These sections typically convey basic information about a document including: unique identifier, title, version, page numbers, security statement and electronic control statement. 6.3.Document Approval Document Type Roles Minimum Required Approvers Policy Author CIO / Global IT Quality System Owner Global IT QA Lead Global IT Quality System Representative Procedure Author Manager (independent from Author) Global IT QA Lead Global IT Quality System Representative Work Instruction Author Subject Matter Expert (independent from Author) Global IT Quality System Representative Guidance Author Global IT Quality System Representative Quality Records Minimum of two approvers, except Learning Management System records which require a minimum of one approver. OLA / SLA Author Manager (independent from Author) Global IT Quality System Representative Customer (required for SLA only) Templates / Forms Author Global IT Quality System Representative a) Where a minimum of two approvers are required. The author can be one of the approvers. b) Those who will be approving or routing for approval shall be trained in document and record control. c) Document Approvers apply an approval to documents and are accountable for the integrity of the entire document with an emphasis on their area of expertise d) One individual can represent multiple roles with exceptions as noted in the Approvers table above. e) Embedded files and links shall not be included in approved records (except as instructional text intended to be removed from templates). Global IT Quality Management System Page 9 of 18
f) records or attachments must be viewable using normal methods (e.g. do not apply password protection to records which limits viewability, do not protect a zip file). g) Contents of referenced documents are not included in the approval but the reference citation must be reviewed for accuracy. h) Faxing of approvals is permitted as long as the original signed document is stored with the fax copy when received and it is via an internally generated fax. If the original is lost, the fax should be confirmed as authentic by the original approver within the fax i) The date of the approval must be recorded with the approval. j) No backdating (or predating) of documents is allowed. The date a document or quality record is approved must be the current date. It is acceptable to additionally document the date an activity was completed. 6.3.1. Approval Delegation When the approver of a document or quality record is unable to sign, the document or quality record can be approved in one of the following ways: a) Delegation: A designee with an authorization from the approver that is documented, approved, and valid for the date the document is being signed. The delegate authorization can be a quality record or can be maintained using the validated document repository delegation functionality. b) The approver s direct manager. c) An email designating and authorizing an alternate approver. The email must be confirmed and approved by the original approver as valid upon the approver s return. The authorization is a quality record. d) A validated system generated authorization granted to the alternate approver. e) Alternate approvers designated in an approved procedure or work instruction (such as a Change Request Approval Matrix). f) An equivalent method defined in an approved procedure. g) In the case where an approver and their direct manager are unable to sign, the approval can be completed by the next level up manager or any manager higher up in the reporting chain. 6.3.2. Electronic and Wet Ink Signatures Documents or quality records may be signed electronically (preferred method), or with wet ink. a) Electronic Approval Documents or quality records will be entered into the document management system and routed through electronic workflow for approval. b) Wet ink signature: o Wet ink signatures must comply with all approval requirements as stated in this document. o Signature components include a legible representation of full name, date, responsibility, and signature. o The wet ink signature must be scanned and added as part of the document being electronically signed off. o The statement for approval needs to indicate that the wet ink signature has been verified to be an exact copy of the original. Global IT Quality Management System Page 10 of 18
o Scanned records containing the wet ink signature components become the system master record. o A scanned copy of a wet ink signature is not an electronic signature. o Black or blue permanent ink shall be used for wet ink signatures. 6.4.Communication of Document Effectivity A quality record document becomes effective on the date of the final approver s signature. An approved status for a quality record is equivalent to an effective status. Quality Management System process documents in D2 MRCS become effective on the date its status is set to effective. Global IT Quality System Representatives are responsible for setting effective status. Quality Management System process documents in Webtop MRCS become effective upon the date listed for the final approver s electronic signature. An effective date can also be noted within the document. This is the document s effective date unless the final approver s electronic signature is later. To ensure that an effective process document is communicated and implemented within the context of the Quality Management System, the Global IT Quality Management System website is updated with appropriate links if needed and training of affected personnel will be conducted per Global IT Training Procedure 86922-SOP. 6.5.Control of Documentation Documents that are managed electronically in the document control repository must be marked to indicate that the electronic copy is the official version of the document. Only controlled copies of documents will be used to support daily activities. Controlled paper and website reference library can be used as reference documentation, provided that the paper copy or website copy is an exact replica of the current approved version. This approach can be used as a contingency plan if the electronic repository is not available. Websites that provide documents should not provide copies of static content but rather should be pulling the most current version directly from the validated document repository. Each group is responsible for management of paper documents and websites that reference documents used by that group. This includes paper documents approved prior to the conversion from the paper system to the electronic system in the document control repository. Handwritten changes or notes or whiteout on paper copies are not acceptable. If changes are needed to existing Global IT Quality Management System documents, requests for change are managed by the document author. 6.6.Document Version Control All documents will be controlled through version level identifiers. The first approved version identifier will be documented and levels will progress sequentially with each approved document change. Changes to controlled documents will be managed as follows: a) The reason for changes will be summarized in the document s history section. b) Document changes will be reviewed and approved as described in the Document Approval section and this entire SOP. c) Completed changes shall be made available to the appropriate personnel in a timely manner. Global IT Quality Management System Page 11 of 18
d) Changes made during the draft process may be tracked outside of the electronic document control system. Version history tracks changes from the previous approval. 6.7.Obsolete Documentation When a document has been identified as obsolete, the document shall be marked accordingly. Obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use. 6.8.Email The use of email as a quality record is discouraged. When it is necessary, the email must be approved and retained as a quality record to confirm authenticity. It is acceptable to use emails as a data input source to create a quality record, such as when a complaint from a customer is received via email. 6.9.Retention When a process generates quality records, the process specifies the record retention times for the quality record. Retention times for quality records are defined in 70654-SOP Records & Information Management Retention Schedule. Storage & Retrieval During the record retention period, the quality record must be readily accessible for use and inspection in a human readable format. Retained quality records shall be legible and stored to minimize deterioration and prevent loss. Records that are stored may be either Active or Inactive. Active records are in use. Inactive records are no longer in use but must be maintained because they have not yet met the retention period. Inactive records must still be accessible even if the system that created the records has been retired. Medtronic Document Management Services Records Center provides record storage services. Disposition Records that have met their retention period are candidates for disposal, unless a legal or tax hold has been placed on the record or set of records. Records subject to a legal or tax hold must be segregated from other records to prevent unintentional destruction before the hold has been released. 6.10. Electronic Signature and Electronic Records The validated document management system shall satisfy applicable Medtronic and 21 CFR Parts 820 & 11 requirements. Electronic signatures must comply with the Corporate Electronic Records and Signatures Policy. If an electronic signature is used to confirm record integrity, even if the meaning of the signature is not approval, the electronic signature must comply with the Corporate Electronic Records and Signatures Policy. Global IT Quality Management System Page 12 of 18
6.11. Paper Quality Records Paper quality records may be scanned and stored as electronic records if following steps are followed. A scanned copy of a paper based signature is not an electronic signature. a) Prior to scanning, all records must be visually inspected for acceptability and any anomalies discovered must be resolved. b) The scanned electronic records must be verified against the original record to assure accuracy, legibility, and completeness of the data transfer. c) The person verifying the electronic record must approve this record as evidence of verification. d) The original paper quality record may be disposed providing all of the following are true: The scanned copy was successfully verified, The electronic repository is validated including 21 CFR Part 11 compliance, There is no current legal hold on the document or quality record, There is no regulation or process that specifically prohibits destruction of the original paper record, and Meets the requirements of 70654-SOP Records & Information Management Retention Schedule. 6.12. Document Security In accordance with 91249-InfoSec-IC, documents in the Quality Management System must be labeled for confidentiality and access to documents must be maintained. Where documents or quality records are stored electronically, secure storage and complete backups must be implemented. 6.13. Legacy Documentation Historical documents, procedures and records for legacy and active systems or applications may reside in their current repositories. New or updated documents, procedures and records shall reside in Global ITs validated document repository, unless there is a business need for them to remain in their current location. Global IT Quality Management System Page 13 of 18
7. Document Review 7.1. Process Document Review 7.1.1. Criteria for QMS Process Document Review. The review of a document will be initiated when one of the following events occurs 1. the document is due for its periodic review 2. required update due to changes to process 3. a new document is created that describes a policy, process or work instruction. 4. a Corporate or Regulatory requirement is established or changed and necessitates a review Global IT Quality Management System Page 14 of 18
7.1.2. Periodic Review for QMS Process Documents Document authors are responsible for periodically reviewing their QMS documents for accuracy and adequacy. Documents will be versioned only if changes are needed. Policies within the Global IT Quality Management System will be reviewed every 36 months ongoing from the last approved or periodic review date. QMS documents types including Procedure, Work Instruction, Agreement, Template and Form will be reviewed every 12 months ongoing from the last approved or periodic review date. Guidance documents are efficiency aids and do not convey requirements so they are excluded from periodic review. 7.1.3. Obsoleting a Process Document When reviewing a document, determine if the document is a candidate for being obsoleted. If the process does not exist anymore or if the process is described in another document, obsolescence should be considered. 7.1.4. New Process Document or Process Change When a new process is identified, a process author drafts the process details. A process draft is reviewed by SMEs and by anyone affected by the process. Agreement on the document and changes requested from the review are reflected captured in the final approved version of the document. If a process change occurs to a current document, the author of the document shall start the review process immediately regardless of the timing of the next periodic review. 7.1.5. Guidance Checklist for Process Documents During the creation and updating of documents, the author can optionally use the guidance document: 128952-GD Global IT QMS Document Author Checklist Guidance. This guidance is an optional productivity aid. Reviewers can also optionally use the checklist to aid in reviewing the document. Global IT Quality Management System Page 15 of 18
7.1.6. Review For new or updated documents, an interim review prior to approval may be conducted. A draft copy of the document with changes should be provided to reviewers. Reviews are an informal process of soliciting input from reviewers, SMEs, minimum approvers and other affected parties. The purpose is to ensure process correctness, completeness and to understand impacts. The review workflow is fluid, dynamic, iterative and flexible. Evidence of review activity is not required because the final approved document represents a culmination of all review input. Reviewers may originate from the following groups in addition to SMEs. This will help to ensure that any impacts from either upstream or downstream can be identified during the review. 1. Users of the process 2. Users that create input for the process 3. Users that use the output from the process If the review is a periodic review and no changes are needed, that information can be tracked and retained by a Global IT Quality System Representative. 7.1.7. Training Any needed training is conducted per 86922-SOP Global IT Training Procedure SOP. 7.1.8. Approval The last step in the review of a new or updated document is the submitting of the document for approval. The minimum approvers that are required to approve the document are identified in section 6.3 of this document. Optionally, approval can also include those who reviewed the document. Global IT Quality Management System Page 16 of 18
7.2.Quality Record Review Reviewers Approvers Document Author 7.2.1. Criteria for Quality Record Review The review of a quality record will be initiated when the document is new and needing approval or the approved document requires an update (i.e. new version for a requirements document). 7.2.2. New or Updated Quality Record When there is a new quality record or an update (revision) to an existing quality record, the document author drafts the initial record or updated version. The document is then reviewed. Agreement on the document and changes requested from the review are captured in the document. 7.2.3. Guidance Checklist for Quality Records During the creation and updating of documents, the author can optionally use the guidance document: 131658-GD Global IT Quality Record Checklist Guidance. This guidance is an optional productivity aid. Reviewers can also optionally use the checklist to aid in reviewing the document. 7.2.4. Review A draft copy of the document is provided to reviewers. Reviews are an informal process of soliciting input from reviewers, SMEs, minimum approvers and other interested parties. The purpose of review is to ensure the record is correct, complete, and adequate for achieving its intended purpose and retained correctly. The review process is fluid, dynamic, iterative and flexible. The results of the review process are reflected in the final approved document so there is no need to retain reviewer s input. Global IT Quality Management System Page 17 of 18
7.2.5. Approval The last step in the review of a new or updated document is submitting the document for approval. Minimum approvers that are required to approve the document are defined in section 6.3 of this document. Additional approval requirements may be found in the process that calls for creation of the record or in project documents (e.g. Validation Plan). 8. Deliverables Deliverable Title Description Record Code 1 Policies, Procedures (SOPs), Work Instructions (WIs), Guidance Documents, Forms and/or Templates, Agreements (Operating Level or Service Level) Quality Record Stored Record See Abbreviations, Acronyms, and Definitions Section in this document. See Abbreviations, Acronyms, and Definitions Section in this document. See Abbreviations, Acronyms, and Definitions Section in this document. ADM3000 unless directly product related, then PRD8000 ADM3020 unless product related, then PRD5000 ADM5000 1 See 70654-SOP for record code definitions and length of time to retain the record. The start of the retention period begins upon approval of the deliverable. 9. Approvals Signing constitutes applying an approval signature prior to issuance. This approval indicates that the approver has reviewed the document and finds it to be adequate, complete and correct. Approvals of this document are maintained using the e-signature functionality of the validated document repository. End of Document Global IT Quality Management System Page 18 of 18