Solutions

HYDRAfor Life Science

Business Solution for the Medical Technology and Pharmaceutical Industry

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MOTIVATION

Between regulation and competitive pressureApart from the regulatory requirements, most medical technology manufacturers and suppliers are quite ordinary manufacturing companies – they process plastic, metal, paper and other raw materials into components and products of high quality. Pharmaceutical manufacturers also process raw materials into finished products. There-fore, it is hardly surprising that a Manufacturing Execution System (MES) is perfect to integrate and comply with standard production requirements. An integrated MES also meets additional requirements such as traceability, data integrity, special processes and terminology.

ISO 13485:2016 specifies that process software must be validated. This also applies to Manufacturing Execution Systems. Regulated manufacturers must run a quality management system complying with this standard in order to pass the usual audits of FDA inspectors.

The business solution HYDRA for Life Science is based on the globally and industry-wide used MES HYDRA. Many of the available MES functions can be configured or para-meterized in a flexible manner. This makes it possible to implement requirements that usually only occur in regulated industries. Consequently, HYDRA for Life Science helps you tackle both challenges: the regulatory specifications and the constantly increasing competitive pressure.

Standard software facilitates regulated manufacturing processes

Regulated production companies need appropriate software support to increase production efficiency. The software must be validated in conjunction with existing processes. As is well known, validation costs vary and can arbitrarily increase. The ISPE GAMP guide „GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems” classifies software in categories and suggests validation procedures for these categories.

Due to the great number of customers and HYDRA’s configurability, the system can be described as standard software. Therefore, the software can be classified in the GAMP software category 4 „ C onfigured products”. This simplifies the standard validation procedure as a GxP computerized system compared to customer-specific applications (GAMP category 5). It is also of great use that MPDV runs a quality management system (QMS) which is certified according to DIN EN ISO 9001:2015.

VALIDATION

GAMP Category 1Infrastructure software

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GAMP Category 3Non-configured software

GAMP Category 4Configured software

GAMP Category 5Custom software

HYDRA used by manufacturers of medical technology, pharmaceutical companies and their suppliers

A number of regulated companies use the MES HYDRA. Manufacturers of all sizes and industries rely on the competence of MPDV’s experts and the wide range of HYDRA functions.

MPDV is also a member of the VDMA working group medical technology. A lively exchange with manufacturers and suppliers ensures that we can respond quickly and adequately to new requirements and current industry trends.

We support companies from the idea to the rollout with a wide range of competent partners. We also look beyond our own horizons and impart specialist expertise in neighboring segments, such as intralogistics, automation and IT infrastructure.

COMPETENCE

Industry-wide standard functions

MES HYDRA provides a vast range of standard functions used globally and by all industries. Apart from conventional production management (e.g. data collection, KPIs, planning, etc.), HYDRA also meets important tasks of quality assurance and HR management.

MES HYDRA

More than

40years of experience in the production

environment

More than

800.000people use HYDRA

every day

About

480MPDV employees

at 13 locations

More than

1.250250 HYDRA installa-

tions worldwide

The functions and benefits of HYDRA and the single modules of our standard software are described in further brochures. You can find these brochures at our homepage mpdv.info/products i

Shop Floor Data Maximum transparency of production orders

Machine Data Reliable, reproducible data to improve machine utilization

Shop Floor Scheduling Optimization of machine assignment and reduction of idle times

Tool and Resource Management Reducing maintenance, setup and provisioning times

Material and Production Logistics Perfect control and monitoring of production material

DNC & Setting Data Reducing setup times due to the automatic provision of NC/setting data

Energy Management Detect energy waste and reduce production costs

Process Data Document, monitor and identify trends

Tracking & Tracing Maximum safety during product manufacture

Dynamic Manufacturing Control Model, monitor and control flexible production processes

Production Inspection Quality inspection and production processes in one system

Goods Receipt Inspection Only introduce impeccable products into the manufacturing process

Complaint & Measure Management Automate the processing of complaints, reduce costs

Test Equipment Management Perform measurements with the specified and operational test equipment

FMEA Avoid failures at an early stage and steadily increase reliability

Time & Attendance Say good-bye to the punch card and hello to electronic time recording

Time Management Basis for effective payroll

Personnel Scheduling Provide qualified personnel at the right place and time

Premium & Incentive Wages Reliable basis for your incentive pay

Access Control Secure buildings, sites and operational areas (e.g. clean room)

HYDRA modules at a glance

Based on the VDI guideline 5600 (IEC 62264 / ISA 95), the following application packages are available:

Industry-specific applications

In addition to the standard functions, HYDRA for Life Science offers software support for many indust-ry-specific applications. Some important scenarios are exemplified on the pages that follow.

Supporting the CAPA process

CAPA (Corrective Actions / Preventive Actions) is one of the most important quality processes of regulated production companies. The CAPA process records, documents and tracks any kind of deviation.

HYDRA for Life Science provides the following software functions to support the CAPA process:

• Enter deviations manually• Generate deviations automatically based on recorded process data and failures in production• Clear presentation of all deviations including sort and filter functions• Edit and process deviations using workflows and assign the deviations to the responsible persons• Connect deviations with inspection orders• Create forms and reports and define individual layouts• Enter, forward and track measures• Extensive analyses of deviations and associated costs in graphical and tabular form including

pivot function• Integrated failure mode analysis

LIFE SCIENCE

Training management for production staff

In all regulated manufacturing companies, production employees must be trained on a regular basis. All measures have to be documented and monitored.

HYDRA for Life Science provides the following functions for training management:

• Integrated HR master data that can be imported from and/or synchronized with an ERP or HR system• Adding all kinds of documents to the stored personnel information in form of a digital personnel file• Managing and assigning qualifications to individual employees• Handling of temporary qualifications and recurring training measures• Automatic reminder of due trainings including notification of defined persons• Integrated work equipment management• Qualification matrix to edit, monitor and prioritize qualifications for each employee• Plan trainings and store certificates of participation• Use the stored qualifications for personnel scheduling in the shop floor• Check the required qualifications when planning

Data integrity with audit trail

Data integrity is both a key challenge and a regulatory requirement for manufacturing companies in the life science industry. The ALCOA+ principle explains all mandatory requirements for all types of quality management systems.

HYDRA for Life Science ensures data integrity with functions that can be summarized under the term „ Audit Trail”. Highlights are:

• Specify the data changes you want to integrate.• Record all changes to defined data.• Assign changes to single persons.• Enter a comment when changing master data (optional or mandatory).• Compare different master data versions.• Define events and actions that require special authorization.• Support of digital signatures and the four eyes principle.• Optionally deactivate the option of disabling any kind of logging.• Configurable long-term archiving.

A for Attributable = Data must be traceable to the person who has collected the data

L for Legible = Data must be readable, even after years in an archive

C for Contemporaneaous = Data must be traced back to the recording time

O for Original = Data must kept in the original stage (no overwriting when changes are made)

A for Accurate = Data must be absolutely correct

+ for other requirements relating in particular to digital data integrity: Complete = Data must be complete (Evident by the Audit Trail) Consistent = Data must be consistent (Evident by the Audit Trail) Enduring = Data must be permanently legible (General data format). Available = Data must be available at all times (Access to archive)

Batch record / device record for more transparency

In medical technology, device records are commonly used to collect information on specific products and articles. The pharmaceutical industry, however, speaks of batch records. In both cases, you have to differentiate between a master record and a history record. The master record includes all specifications and plans for a specific product type. The history record informs about the production process and all resources involved in a specific item. Either a serial number (device history record) or a batch (batch history record) identifies this item.

HYDRA for Life Science can integrate and show master records and history records. Master records also require links to external sources. HYDRA for Life Science provides the following functions to display batch and/or device records:

• Summary of work, inspection and maintenance plans• Definition of collection rules, production variants and material assignments• Collection and documentation of all data occurring during the manufacturing process

– Used machines and tools – Involved employees – Used material – Malfunctions occurred – Performed maintenance activities – Due and performed inspections including results – Used test equipment including proof of calibration

• Overview of material movements and order-related postings• Logging of changes to specifications by versioning• Print, export and archive batch records and/or device records

Documentation and traceability

Complete and reliable documentation of the manufacturing process is, on the one hand, an important regulatory requirement (e.g. 21 CFR Part 11) and, on the other, ensures traceability of the manufactured products and their components. Traceability in turn has two main objectives: Patient safety and cost efficiency. It goes without saying that patient safety can only be guaranteed if the materials used in a product are documented properly. If a failure occurs, all affected products can then be recalled. Reliable identification of affected products prevents the recall costs from getting unnecessarily high. In the end, patient safety is much more essential, but the economic efficiency of manufacturers should not be neglected.

HYDRA for Life Science consistently documents the complete manufacturing process. Therefore, HYDRA for Life Science offers a wide range of evaluations and tools to identify failures and affected products and/or batches. Essential functions:

• Collect, save and visualize any kind of process data• Automatically generate failures in the event of anomalies• Document the used material batches, machines, tools and other resources• Personal assignment of work steps, inspections and releases• Precise documentation of existing specifications (versioning)• Tracing of specific material batches including where-used list in the batch tree• Long-term archiving of all data including export option

Quality risk management with FMEA

Product quality and reliability play an important role for regulated production companies - particularly in view of patient safety. According to ISO 13485 and 21 CFR 820, businesses must implement a risk management system. A risk management system is intended to support businesses in maintaining high quality standards for their products and thus to avoid risks for patients and users.

Providing the application Failure Mode and Effects Analysis (FMEA), HYDRA for Life Science supports a targeted method to identify failures at an early stage and to avoid these failures by appropriate measures. Important HYDRA-FMEA functions:

• Create and analyze failure nets by drag & drop• Calculate and assess risks using KPIs

– Severity of the failure – Probability of occurrence of the failure cause – Probability of failure detection

• Define and trace countermeasures• Specify system elements and measures to detect, avoid and eliminate identified risks• Create reports and configurable evaluations• Reuse analysis results as inspection plans for quality assurance

Reliable access management

Access control is an increasingly important issue, in particular for regulated manufacturing companies – not least due to legal requirements. In contrast to conventional locking systems, modern access control systems offer many benefits. This mainly affects the logging of accesses and access attempts. Higher flexibility in assigning access authorizations and lower costs, especially in case a badge is lost compared to a lost key, also speak in favor of an electronic system.

HYDRA for Life Science and the integrated access control system specify when and where authorized persons gain access without hindrance. At the same time, the system protects against unauthorized access. HYDRA provides the following, essential functions:

• Specify individual access profiles for groups and single persons• Assign exceptional authorizations• Define individual access hours for specific times and weekdays including exceptions• Use secure identification methods

– Non-contact ID cards (e.g. RFID) – Biometrics (e.g. finger print)

• Record accesses and access attempts• Record alarms and malfunctions• Define and monitor zones including rescue lists• View the current access statuses in the security control center• Support of offline components for access points without direct electronic connection

Further assistance with implementation and validation

We support our customers in the challenge of meeting standardized and legal requirements. We assist our customers during the validation process as part of MES implementations and international rollouts. Consequently, we save our customers’ limited resources and assure conformity with the requirements of the manufacture of pharmaceuticals and medical devices.

With our Best Practice workshops we prepare you for these new challenges and free up your resources. Your key users gain detailed application knowledge by attending our software training courses on specific modules at our training centers or in-house at your site.

Some of our services:

• Analysis workshops• Detailed specifications• Preparing specification sheets• Advanced project management• System test, GoLive support• Hypercare

For the validation process, we support you throughout the entire HYDRA life cycle, from the introduction including support for future validations to revalidation for release changes.

Our GxP risk-based GAMP5 approach and a state-of-the-art validation safeguard your investment.

HYDRA for Life Science is a sophisticated MES industry solution and meets the requirements of electronic data collection as stated in the FDA regulation 21 CFR part 11.

Our customers from regulated industries have been auditing our processes for many years now – undisputed in all cases. We benefit here from documenting all our processes in accordance with DIN EN ISO 9001:2015.

SERVICES

© 2019 MPDV Mikrolab GmbH l Doku-Ident: LifeScience EN 10/2019.Unless otherwise stated, the images used are from MPDV or Adobe Stock and are released for publication by the respective author.

MPDV Mikrolab GmbH · Römerring 1 · 74821 Mosbach+49 6261 9209-0 · info@mpdv.com · www.mpdv.com

Your partner in the regulated production environment

MPDV Mikrolab GmbH headquartered in Mosbach, Germany, is the market leader of IT solutions for the production sector. With more than 40 years of project experience in the production environment, MPDV has extensive expertise and supports companies of all sizes on their way to the Smart Factory. Products such as the Manufacturing Execution System (MES) HYDRA by MPDV or the Manufacturing Integration Platform (MIP) enable production companies to streamline their processes and stay one step ahead of the competition. The systems can be deployed to record and evaluate production-related data along the entire value chain in real time. If the production process is delayed, employees can immediately detect the problem and take proactive measures. More than 800,000 people in over 1,250 production companies worldwide use MPDV’s innovative software solutions every day. These include renowned companies from all industries. The MPDV group currently employs 480 people at 13 sites in Germany, China, Luxembourg, Malaysia, Singapore, Switzerland and the USA.

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