quality assurance of the highest standard - itac...

iTAC solutions for the medical industry

Quality assurance ofthe highest standardFDA-compliant. Reliable. Productive.

In addition to full FDA conformity, seamless traceability,

which makes production documentation available during the

actual process on a real-time basis, is one of the most

important objectives when implementing an MES solution.

A further goal is to optimise the production process, so

that failures can be prevented before they occur rather than

being subsequently documented. Furthermore, as a rule the

MES system assumes responsibility for quality management,

which was previously often realised with stand-alone

solutions.

Workflow capability (4-eyes principle) and (wherever

possible) paperless manufacturing processes are two other

demands made of an MES system for the medical technology

industry.

Software selection

The specic requirements and

demands of the manufacturers of

medical devices such as FDA

conformity, small batch sizes,

complex products requiring the

highest levels of quality and

reliability are among the stringent

requirements that have to be

met by a dedicated MES solution.

The iTAC.MES.Suite stands out due to its high level of

standardization.

iTACs MES solution is characterised by a manageable

number of enhancements for fullling FDA requirements.

It can be validated in close collaboration with the companies

concerned, meaning it can replace proprietary solutions.

In addition to many years experience, of signicance is

iTACs strategy for supporting zero-failure production

processes (active traceability).

Market Requirements

1 Statutory regulations and stringent requirements laid down by the American regulatory authority, FDA

Extremely complex devices

Highly automated production processes on the one hand a large number of manual workplaces on the other

2

3

Since production faults in the medical technology industry, in

particular, can have serious consequences, quality assurance

plays an especially crucial role.

Above all, immense challenges are posed by comprehensive

statutory regulations and the requirements stipulated by the

American regulatory authority, FDA (FDA cGMP, 21 CFR Parts 11

and 820).

The defined requirements

stipulate, among other things,

FDA-compliant system support

as well as detailed

documentation of all production-

related processes and

specifications, so that in the

event of a recall the medical

product can be traced from the

manufacturer through to the

customer.

Objectives

Continual improvement in customer benefits, quality

and productivity are among the key corporate goals of

companies operating in the medical technology industry.

A systematic quality management system should

guarantee a high level of operational reliability

in production, while enabling ongoing competitiveness.

MES standard software for transparency and reliability


By interlocking individual processes and work operations,

the iTAC.MES.Suite minimises the rate of defective products

during the manufacturing process.

The capability for creating a completely paper-free

manufacturing process including change workflows with

electronic and digital signatures is frequently another

important selection criteria for choosing the iTAC.MES.Suite.

Web-based access also enables the MES software to be

deployed across multiple remote locations.

Requirements & deployment of an MESsolutionSince many medical device manufacturers export a large

proportion of their products to the United States, they

have to comply with various FDA regulations. These

manufacturers regularly verified during audits and certified

accordingly.

A Quality Management manual, procedural instructions,

primary product files, work instructions, medical device

reports, CAPA plans, design validation - the requisite

documentation and records for an audit are extensive.

The requirements laid down in CFR 21 Part 821, which

stipulate that the manufacturer must be able to trace the

medical device in the event of a recall, can be fulfilled

with the assistance of the iTAC.MES.Suite - standard.

Continuous real-time product tracking at unit or container

level - from the materials used through to the packaged

product, and from the supplier to the customer - is

possible with the solution as delivered.

Device Master Record (DMR)

The documentation of production processes as well as

compliance with production specifications are among the

challenges faced by FDA-regulated manufacturing companies.

The stipulated requirements include detailed documentation

of all the production-related processes and specifications.

By implementing these requirements, it can be assured that

every single manufactured item incorporates the latest

changes made at the planning level.

Component list data and activity schedules from the ERP

system, test plans from the engineering department, work

instructions and specifications from the document

management system - the iTAC.MES.Suite compiles a so-

called Device Master Record (DMR) for every single

product stating how it is to be manufactured. This data

is imported from the ERP system and prepared accordingly.


Highly automated electronics manufacturing

The iTAC.MES.Suite minimises the production of

defective products by interlocking individual process

and work steps. The system runs checks at every stage

of the production process to establish whether the

components and assemblies stipulated by the product

developers have been installed and that the defined

production process parameters are being adhered to.

If any faults appear in a component or assembly during

the production process, the affected unit is not processed

any further, but is subjected to a pre-defined escalation

procedure where it is analysed, repaired, re-checked and

then released or scrapped. This allows faults in the

production process to be detected and remedied at an

early stage and in real time.

This is made possible through bidirectional communication

between the various manufacturing machines via

standardised software functions (API service adapters)

that have been integrated into the machinery, control

systems and the test or SPS/PLC systems.

Operator support & release workows

The iTAC.MES.Suite can be used to create and verify work

instructions and to ensure that they are complied with.

Using a PC-client, production employees can follow the

relevant work instructions and explanations directly on-

screen without being able to make any changes to the

document.

Before the next workstep can take place on a machine,

the operator must confirm electronically that the

document in question containing details of the next

steps has actually been read.

Device History Record (DHR)

Documentation of the actual production processes is

mandatory. iTACs Manufacturing Execution System

generates an electronic Device History Record (DHR) for

every single manufactured item which can be viewed in

the ERP system. This obviates the need for laboriously

compiling paper-based data, a process which is

extremely susceptible to errors.

Every step of the process, every calibration and all the

measurement data are retrieved directly from the

respective systems and matched against the DMR. This

ensures that the product is constructed according to

specifications.

Suppliers batches of components installed are

documented, while the production and process-related

data is recorded, verified and stored in the central

database. This guarantees that every single item can be

traced back to the supplier's batch of installed

components, including references to the operation in

question and the production employees.

ERP integration

Integrating the respective ERP system in the iTAC.MES.Suite

provides companies implementing the software with a

global, standardised traceability solution that verifies

every stage of the production process and guarantees

the highest quality.

iTAC Software AG's manufacturing execution system features

active traceability functionality which identifies quality

problems during the production process in real time,

analyses the causes, and provides a prompt and systematic

evaluation of remedial measures as part of a continuous

improvement process.


Electronic signature

CFR 21 Part 11 specifies how electronic recordings and

signatures are to be handled. Who has changed which

parameter variable to what other variable and when? -

Companies in the medical industry must be able to

answer these questions at all times.

In order to comply with the requirements laid down in

FDA 21 CFR Part 11, certain values that are entered

manually into the system must be confirmed

electronically (electronic signature).

This is usually done by entering a user name together

with the matching password, which expires after a

defined time and is blocked for security reasons if it is

entered incorrectly.

The iTAC.MES.Suite is capable of mapping the entire

electronic signature system. If an incorrect or non-

authorised password is entered, the software blocks

the subsequent work steps. Workflows for releasing the

electronic DMR documents play an important role here.

Information is only passed on to the DHR in the ERP

system with a serial number if the verification is

successful.

This release workflow, with the assignment of

permissions (electronic signature), not only guarantees

that predefined processes are observed, it also supports

follow-up traceability. All details regarding who has

confirmed which work step or who has confirmed that

he has read which work instructions using his password

are saved as well.

Paperless repair & returns processing

As a rule, semi-automated production processes involve

the circulation of many different pieces of information

(catalogues, job tickets, etc.). This information can now

be administered from a single point of control with the

help of the iTAC.MES.Suite. As soon as the relevant

serial number has been scanned, the test data for the

products to be repaired already recorded in the QM

system can be viewed from any workplace immediately

after verification. This is made possible by the

corresponding paperless repair functions, which send

the test results from the individual production lines to

the iTAC.MES.Suite database.

The iTAC.MES.Suite issues a work plan for returns stating

all the necessary repair steps. With the aid of the operator

support functionality, the person at the repair and

diagnosis workplace is also provided with all the necessary

and appropriate documentation such as the layout, circuit

diagrams, wiring diagrams, etc., for the relevant product

in paperless form.

The iTAC.MES.Suite restricts further processing if the repair

cannot be carried out at all or only incompletely. The causes

of faults and the corresponding repairs are recorded,

together with the repair time that is actually needed and the

name of the person who carried out the repairs.


Semi-automated assembly workplace

Summary

The iTAC.MES.Suite is capable of meeting the specific

requirements of manufacturers of medical devices out

of the box.

By implementing the MES software, companies can replace

their previous stand-alone solutions, fulfil their own

stringent quality management requirements, and do so in

compliance with statutory regulations (FDA, ISO). The iTAC

solution enables companies to systematically optimise

their manufacturing and quality processes and increase

productivity.

The iTAC.MES.Suite gives medical technology industry

enterprises full traceability capability, and makes their

manufacturing processes more transparent and efficient.

All the trace data is available in real time during the

actual processes, which can be interlocked to prevent

failures from occurring in the first place.

Dynamic work plans

Repair jobs at many companies are recorded manually in

so-called service reports in the ERP system. If ERP access

is not available to every employee, work instructions are

provided on paper. Once the repairs have been carried

out, these steps have to be recorded by hand in a

subsequent step.

Another factor here is that work and test steps have

frequently been statically defined in advance, and it is

always necessary to go through each step in each case.

In deploying state-of-the-art MES software, the work plan

can now be dynamically adapted in line with the products

specifications, validated, released via the defined

workflow and then used for production.

Corrective and preventive action can now also be

initiated.

Document and data management

Current or modified versions of documents can be made

available to defined groups of users based on an

integrated permissions concept with the help of the

document management module. This ensures that only

correct and valid manufacturing documents are used in

the production process.


Conformity with statutory regulations

FDA: FDAGNP, 21 CRF Part 11 und 820,

requirements for traceability of electronic

assemblies.

ISO 13485: Requirements to be met by quality

management regarding recalls and for

safeguarding products


Standardised interface for ERP systems and

Automatically generated DHRs

Paperless manufacturing

Modular service architecture for meeting initial

requirements and permitting future expansion

Extensive and scalable function portfolio

Benets of iTAC.MES.Suite

manufacturing machinery


www.itacsoftware.com

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iTAC Software AG

Burgweg 19

56428 Dernbach, Germany

tel +49 2602 1065 - 0

fax +49 2602 1065 - 30

[email protected]

www.itacsoftware.com

Certied in compliance with

ISO 9001:2008 certied by DQS

iTAC.MES.Suite facilitates

Seamless, transparent manufacturing processes in real time

increased productivity with optimised production processes

the prevention of failures from the outset by interlocking

processes and with preventive strategies

paperless manufacturing in digital factories

release workows with electronic signatures

conformity with FDA and ISO 13485

mapping of Device History Records (DHR)

mapping of Device Master Records (DMR)

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