Quality System

Requirements for
Documents, Records and
Change Control
Katja Sundström, CI Manager
20.03.2013

1 © 2009 PerkinElmer
 TURKU SITE
ONE OF THE LARGEST
MANUFACTURING AND R&D
FACILITIES IN PERKINELMER
Centre of Excellence for Diagnostics Devices

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 We develop and manufacture
instrumentation, reagents and software
for screening and research purposes

We are the world leader in newborn screening

systems and 1st trimester prenatal screening

We have extensive capabilities in cytogenetics

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 OUR CUSTOMERS
We provide products and services to over 90 countries over the
world, to all continents.
Our customers are public and private hospitals and laboratories
around the globe, served by our own sales organization and nearly
100 distributors

Customer sales 2011 by region In the US, our biggest customers are the states of:
North America
CALIFORNIA
19 % Western Europe TEXAS
FLORIDA
44 % OREGON
10 % Eastern Europe,
Middle East, Africa GEORGIA
ALABAMA
South America
16 % NEW JERSEY
11 % ARIZONA
APAC NORTH CAROLINA
ARKANSAS

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Medical Device Regulatory Environment

Quality System certified against ISO 9001:2000 and

ISO 13485:2003 (Medical Devices – QMS)
Gives general structure and modern approach

IVD Directive
European CE mark
Competent Authority
Notified Body audits of both the
quality system and specified products

US 21 CFR Part 820*

CFR US Code of Federal Regulations
21 Federal Food, Drug and Cosmetic Act
Part 820 QSR = Quality System Regulation

510(K), PMA (licenses)

Comprehensive inspections for
both QS and PAI

Brazilian National Health Vigilance Agency

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Document, Record and Change Control Requirements

Expected to establish and maintain a documented system to develop, identify,

distribute, change and control all documentation required by Quality System
System applies to all product, process, and quality assurance documentation

Required to keep all records mandated by, or kept in order to comply with, the
Quality System, whether or not the record is product specific, available and
accessible

Control changes made to product, process and documents in such a manner that
the change, reason, impact analysis including risk, and implementation tasks are
identified, traceable and documented

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Document, Record and Change Control

Traceability (jäljitettävyys)
Accountability (vastuuvelvollisuus)
Authenticity (oikeellisuus)
Evidence of Business (todistusvoima)

All products must be safe, effective, and fit for its intended use; the quality
characteristics of a product (determined during the NPD process) that make it safe,
effective and fit for its intended use are established in documents.

Documents declare product standards and describe how to monitor, test and judge for
compliance with these standards. Developing, writing, and implementing the
specifications, manufacturing records, and procedures establish quality.

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QMS Documents and Records

External
Quality Quality
standards Policy Records

Quality
Regulatory manual
Device History
requirements Records

Procedures

Guidances Device Master

Records
Work
instructions

Design History
Records, documents Files

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 Document Control

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 Document Control Requirements

FDA CFR 21, 820

820.40 Document Controls
820.180 General Controls

ISO 13485:2003
4.2.1 Documentation requirements - General
4.2.3 Documentation requirements – Control of documents

Requirements are similar; the standard has an additional requirement of

control of documents of external origin.

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 Document Control Requirements

In one way or another, document control affects all aspects of a

manufacturer’s operation and activities in
Design
Purchasing
Production
Testing and inspection
Quality assurance
Installation
Service
Materials
Product
Equipment

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 820.40 Document Control

QSR 820.40 Document Control

a) Approval and Distribution a) Hyväksyntä ja jakelu

- Establish (= define, document, do) and - luo ja ylläpidä menetelmät jolla hallita
maintain procedures to control all kaikki vaaditut dokumentit
required documents

- Designate individual(s) to review - määrittele vastuuhenkilöt tarkastamaan

documents for adequacy and approve ja hyväksymään dokumentit ennen
prior to issuance voimaan astumista

- Make documents available at designated - varmista että dokumentit ovat saatavilla

locations määritellyissä paikoissa

- Remove obsolete documents from all - poista vanhentuneet/ei enää voimassa

points of use to prevent unintended use
olevat dokumentit

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 820.40 Document Control

QSR 820.40 Document Control

b) Document changes b) Dokumenttien muutokset

- Review/approval of changes by - tarkastajat ja hyväksyjät samasta

individual(s) in the same toiminnosta kuin alkuperäisessä
function/organization as original dokumentissa
review and approval
- Kommunikoi muutoksista
- Communciate approved changes
to appropriate personnel

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 820.40 Document Control
QSR 820.40 Document Control
b) Document changes
- Maintain records of changes,
including
- Description of change
- Identification of affected
documents
- Signature of the approving
individual(s)
- Approval date
- When change becomes effective
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b) Dokumenttien muutokset
- ylläpidä muutostallenteita jotka
sisältävät
- Kuvauksen muutoksesta
- Mihin dokumentteihin muutos
vaikuttaa
- Hyväksyjän allekirjoitus
- Hyväksymispäivämäärä
- Voimaan astumispäivämäärä
 Document Control Requirements

Typical document control process mechanics:

The need for the document is justified
The scope fo the change is described
The new document is evaluated (e.g. regulatory status, effect on risk, design
change requirements, validation)
The current and proposed revision levels are identified
The effectivity of the change is assigned by e.g. date
If applicable, the disposition of raw materials, components, work in progress,
finished goods and distributed devices is assigned
The responsibility for implementing the change is designated
Training requirements is determined
The document is routed for review and approval
The document/changes is communnicated
The document is distributed and obsolete versions removed

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 Document Control Requirements

The documentation system must encompass all new

documents AND changes to existing controlled documents
It must ensure that
Accuracy and use of documents are controlled
Obsolete documents are removed or prevented from being used
All documentation is adequate for its purpose

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 Record Control

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 Records Control

FDA CFR 21, 820

820.180 Records, General Controls
820.181 Device Master Record
820.184 Device History Record
820.186 Quality System Record

ISO 13485:2003
4.2.4 Documentation controls – Control of records

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 Records Control Requirements Comparison

21 CFR 820 13485:2003 Similarities

820.180 General None Regulation specifically requires back up of records stored
in data prosessing systems. Regulation requires the
availbility fo records to officials and FDA employees.
820.180(a) None Regulation provides for marking records confidential
Confidentiality during inspection.
820.180(b) 4.2.3., 4.2.4 Similar requirements.
Retention
820.180(c) None Regulation excempts certain records from review by FDA
Exceptions during inspections.
820.181 DMR 4.2.1, 7.1 Similar requirements.
820.184 DHR 7.5.1.1 Similar requirements.
820.186 QSR None Standard does not require QSR but does require the
types of records and documents that should be kept in
the QSR

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 Records Control

Records of product development, product manufacturing, and testing

events are a products in themselves. Without records, a product can
not be introduced to the market; if destroyed or lost, a product may
be recalled. Therefore, records should be managed in as controlled
manner as products.

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 Records Control – Electronic records

When records are electronic:

Backups are required
Validation of electronic recordkeeping systems is required
general validation requirements in CFR 820.70(i)
Validation applies to any system used to create or maintain records
Specific requirements for an eRM system and validation are in 21 CFR
Part 11 ”Electronic Records; Electronic Signatures”

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 Subpart M – Records; 820.180 General Requirements
QSR 820.180 General requirements/yleiset vaatimukset
Maintain all required records at
manufacturing establishment, or other
reasonable location
Make records readily available for review
and copying by FDA
Ensure records are legible and stored to
minimize deterioration and prevent loss
Back up records stored in automated
data processing systems
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Säilytä tallenteet paikanpäällä (=
arkisto)
Varmista että tallenteet ovat
saatavilla tarvittaessa 24 tunnin
sisällä tarkastustilanteessa
Varmista että tallenteet säilyvät
luettavina, ja säilytettynä siten että
ympäristön haitalliset vaikutukset
voidaan minimoida ja jotta voidaan
ehkäistä häviäminen
Varmista sähköisten tallenteet
varmistuskäytäntö
 Subpart M – Records; 820.180 General Requirements

QSR 820.180 General requirements/yleiset vaatimukset

a) Confidentiality a) Luottamuksellisuus
- Mark to aid FDA in determining whether
information should be disclosed under the - Varmista että luottamuksellinen
public information regulation materiaali on merkitty luottamukselliseksi

b) Record retention b) Säilytysaika

- Retain for a period of time equalent to the - Säilytä asiakirjat ainakin tuotteen eliniän
design and expected life cycle of the
device, but in no case less than 2 years mutta ei koskaan lyhyemmän aikaa kuin
form the date of release 2 vuotta valmistuspäivämäärästä

c) Exceptions (to FDA inspections) c) Poikkeukset (tarkastuksen

- Does not apply to reports required by yhteydessä)
- Management review (820.20(c))
- Ei tarvitse näyttää MR pöytäkirjat,
- Quality audits (820.22)
- Supplier audit reports used to meet the
sisäiset audit raportit (laatu ja toimittaja)
requirements of 820.50(a)

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 Subpart M – Records; 820.181 Device master record
QSR 820.181 Device Master Record (DMR)/Tuotteistamisdokumentaatio
DMR means a compilation of records
containing the procedures and specifications
for a finished device.
Purpose is to document the performance and
configuration charachteristics in order to
control them.
a-e) establish and maintain for each type of
device, including
- Device specifications
- Production process specifications
- QA procedures and specifications
- Packaging and labeling specifications,
- Installation, maintenance, and servicing
procedures and methods
Prepare and approve DMR in accordance with
820.40, Document Controls
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DMR on kokoelma asiakirjoja jota sisältävät
lopullisen tuotteen menetelmät/ohjeet ja
spesifikaatiot.
Tarkoitus on dokumentoida suoritus ja
konfiguraatio ominaisuudet jotta ne voidaan
hallita.
a-e) Ylläpidä jokaisesta tuotetyypistä
sisältäen
- Tuotteen spesifikaatiot
- Tuotannon prosessin spesifikaatiot
- QA’n menetelmät ja spesifikaatiot
- Pakkausten ja etikettien spesifikaatiot
- Installoinnin, ylläpidon ja huollon
menetelmät ja ohjeet
Valmistele ja hyväksy DMR’t noudattaen
820.40 vaatimuksia
 Subpart M – Records; 820.184 Device history record
QSR 820.184 Device History Record (DHR)/Tuotantodokumentaatio
DHR means a compilation of records
containing the production history of a finished
device.
Intended to provide objective evidence that the
requirements of the DMR were met and to
provide traceability.
a-f) maintain the DHR in accordance with
procedures including
- Date of manufacture
- Quantity manufactured, and released for
distribution
- Acceptance records
- Primary identification label and labeling
used for each production unit
- Any device identificaiton(s) and control
number(s) used
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DHR on kokoelma asiakirjoja jota sisältävät
lopullisen tuotteen tuotantohistorian
Tarkoitus puolueettomasti toimittaa todisteita
siitä että DMR:ää on noudatettu, sekä toimittaa
jäljitettävyyttä tuotteisiin.
a-f) ylläpidä DHR kuten ohjeet vaativat,
sisältäen
- Valmistumispäivämäärä
- Valmistumismäärä ja määrä vapautettu
toimitettavaksi
- Hyväksyntät
- Ensisijaiset tunnistettavuustiedot
sisältävät etiketit ja pakkaukset
jokaiselle tuotantoyksikölle
- Käytetyt tunniste- ja kontrollinumerot
 Subpart M – Records; 820.186 Quality system record

QSR 820.186 Quality System Record (QSR)/Laatutallenne

Establish and maintain a QSR to
include procedures and documentation
of activities not specific to a particular
type of device
- Prepare and approve QSR in
accordance with 820.40, Document
control
- Examples
- Nonconformance procedures
- CAPA procedures and records
- Calibration records
- Preventive maintenance records
- Complaint procedures
Luo ja ylläpidä laatutallenne sisältämään
menetelmät ja dokumentointi toiminnoista
jotka eivät ole tuotespesifisiä
- Valmistele ja hyväksy
laatutallenteet noudattaen 820.40
- Esimerkkejä
- Poikkeama menetelmät
- CAPA menetelmät ja tallenteet
- Kalibrointitallenteet
- Ennalta ehkäisevän huollon
tallenteet
- Valitusmenetelmät

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 Documentation process summary

Essential Characeristics of the documentation process

1. The document directing the process is appropriately written,
reviewed and approved.
2. The document is appropriate for the task or process.
3. The data to record the task or process is authentic.
4. The data is accurate.
5. The data is complete.
6. The data is legible, consistently recorded, and trustworthy.
7. The data collected fulfills specifications.
8. The data is accessbile to those who need it.
9. The original data and document is retrievable for review or audit.
10.The original record is secure.

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 Change Control

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 Change Control

In accordance with many regulatory standards and guidelines,

change control - or controlling or managing change within an
organization- must be conducted to ensure that the organization can
maintain and improve quality by identifying changes that could
improve the product, ensuring proper review and analysis of the
changes, and documenting and communicating the changes to
the appropriate stakeholders.

For example, the ISO regulations, having a continual improvement and

document control tone, infer that change should be managed. In addition, the
medical device regulations of 21 CFR Part 820, specifically regulate change
management.

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 Change Control Scope

Change control activities and procedures apply to:

design;
components, including software;
labeling and packaging;
device manufacturing processes;
production equipment;
manufacturing materials; and
all associated documentation such as
quality system procedures,
standard operating procedures,
quality acceptance procedures and data forms, and
product-specific documentation.

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 Change Control Scope

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 Change Control Requirements

CFR 21, 820.30

(i)Design changes. Each manufacturer shall establish and maintain procedures for the
identification, documentation, validation or where appropriate verification, review, and approval of
design changes before their implementation.

CFR 21, 820.40

(b)Document changes. Changes to documents shall be reviewed and approved by an individual(s)
in the same function or organization that performed the original review and approval, unless
specifically designated otherwise. Approved changes shall be communicated to the appropriate
personnel in a timely manner. Each manufacturer shall maintain records of changes to
documents. Change records shall include a description of the change, identification of the affected
documents, the signature of the approving individual(s), the approval date, and when the change
becomes effective.

CFR 21, 820.50

(b)Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or
reference the specified requirements, including quality requirements, for purchased or otherwise
received product and services. Purchasing documents shall include, where possible, an
agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of
changes in the product or service so that manufacturers may determine whether the changes may
affect the quality of a finished device. Purchasing data shall be approved in accordance with
820.40.

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 Change Control Requirements

CFR 21, 820.70

(b)Production and process changes. Each manufacturer shall establish and maintain
procedures for changes to a specification, method, process, or procedure. Such changes
shall be verified or where appropriate validated according to 820.75, before implementation
and these activities shall be documented. Changes shall be approved in accordance with
820.40.

CFR 21, 820.75

(c) When changes or process deviations occur, the manufacturer shall review and evaluate
the process and perform revalidation where appropriate. These activities shall be
documented.

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 Change Control

In order for an organization to minimize the risk that

changes can have on the organization, the organization
must identify these potential changes, thoroughly
evaluate the impacts of the changes and the risk of not
doing them, obtain the necessary approvals,
communicate with the affected parties, and create
action plans to implement the changes.

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 Change Control Process

Describe the current process

Describe the proposed change
Perform a risk analysis and impact assessment
Develop a qualification program where necessary
Develop a regulatory strategy
Develop an implementation strategy
Implement the change
Execute the qualification studies where necessary
Implement the regulatory strategy
Monitor the process to determine any long term effects from the
change

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 Document, Record and Change Control – Summary repeated

Expected to establish and maintain a documented system to develop, identify,

distribute, change and control all documentation required by Quality System
System applies to all product, process, and quality assurance documentation

Required to keep all records mandated by, or kept in order to comply with, the
Quality System, whether or not the record is product specific, available and
accessible

Control changes made to product, process and documents in such a manner that
the change, reason, impact analysis including risk, and implementation tasks are
identified and traceable

DEFINE, DOCUMENT, DO - IN A CONTROLLED MANNER

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Thank you!

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