VALIDATION & COMPLIANCE
ENGINEERING

Kylie Brailsford

Validation & Systems engineering Manager

Contact Kylie for any Validation & Compliance Inquiries

  • Validation
  • Data Integrity
  • ERP Validation
  • Temperature Modelling

Validation services

validation services

Validation Capabilities

Synertec is an ISO9001 certified company and therefore we understand what it takes to develop and maintain a compliant quality system and to deliver products that meet client’s needs.

Synertec’s experience and knowledge are centered around a team of dedicated engineers and scientists who not only understand the technology and processes in a wide range of industries but also have hands-on experience in implementing compliant solutions in these industries. 

Based on this extensive experience Synertec’s team can identify and “translate” the applicable regulatory requirements and standards that are best suited to the project and the organisation. 

Once the applicable standards are identified, Synertec can then implement a compliant strategy that is sustainable, risk based, cost-effective, and pragmatic enabling a solution that is the “right fit” for the organisation.

Track Record

Synertec’s areas of expertise include:

  • Development and maintenance of compliant quality systems
  • Continuous improvement planning
  • Risk assessment and risk management
  • Change management
  • Training
  • Audit readiness inspections and remediation planning/execution
  • Process mapping
  • Verification and validation of equipment, systems and processes
  • Design, construction and qualification of cleanrooms and isolation suites

Data Integrity services

secure network concept. isometric 3D render.

Why is Data Integrity Essential?

The ISPE (International Society of Pharmaceutical Engineers) have recently published guidelines on the need for and use of data integrity; Any data that is used to make a decision which will affect product quality, patients and those being administered the products, or is regulated is subject to the requirements stipulated by the ISPE. Both electronic data and paper records of this affected data must comply with these standards.

Synertec’s Solution

With in-house Data Integrity specialists, Synertec can ensure that comprehensive independent data integrity audits are carried out to comply with the ISPE regulations.

This is achieved through client workshops and risk assessments to determine the critical data on your site. 

 Audit checklists which have been developed through our experience in Data Integrity analysis are used to check compliance. A report is generated for our customers detailing Data flow maps and areas of compliance.

If required, Synertec can provide a Data Integrity policy which can ensure that all future critical data will comply with the ISPE standards.

ERP Validation Services

project management planning

ERP Validation Capabilities

Synertec is recognised as an industry leader in all aspects of validation and has an enviable reputation in the validation of Enterprise Resource Planning (ERP) systems. 

In acknowledgement of this, Synertec has delivered technical presentations alongside the TGA, at a number of ISPE seminars on “ERP Validation in a Regulated Environment”. 

Synertec’s knowledge of TGA, FDA and other regulatory requirements has seen Synertec work with organisations such as:

  • Pfizer
  • Baxter
  • CSL
  • Hospira (Mayne Pharma)
  • GlaxoSmithKline
  • Wyeth
  • Cochlear
  • Ventracor
  • ResMed
  • Universal Biosensors
  • Pharmaxis
  • Bayer

Relevant Experience

Synertec is accustomed to validating a wide range of systems for clients and working with various system vendors, including: 

  • Microsoft NAV ERP system at Parnell, Pharmaxis and CathRx in Sydney and Universal Biosensors in Melbourne
  • MAPS, Pfizer’s global Manufacturing Accounting & Planning system, West Ryde
  • De-integration of MAPS at Pfizer, Caringbah, following the acquisition of Pfizer’s Consumer  Health Business by Johnson & Johnson
  • Upgrade to Oracle ERP system, at ResMed
  • Pronto ERP system at Mediherb, Warwick (Queensland)
  • MFG PRO at PanBio, Brisbane
  • JD Edwards ERP system at Symbion, Brisbane
  • SAGE at Agen Medical, Brisbane
  • SAP ERP at Ego Pharmaceuticals, Melbourne, and iNova, Sydney

Synertec appreciates the business imperatives of different organisation structures and cultures and strives to deliver regulatory compliance solutions which are commercially pragmatic.

Temperature Modelling services

temperature modelling services

Temperature Modelling Capabilities

Synertec’s areas of expertise in validating controlled environments (through mapping of temperature, humidity and pressure) include:

  • Autoclaves
  • Incubators
  • Fridges and freezers
  • Hot air ovens
  • Cold rooms
  • Clean rooms

Synertec owns state-of-the-art measurement and calibration instruments to deliver cost-effective qualification solutions. Synertec takes care of the validation process from protocol development, protocol execution and through to the delivery of validation reports and certificates. 

Relevant Experience

Synertec’s experience and systems allow the company to offer cost-effective and time-efficient temperature mapping solutions that are compliant to the following standards: 

  • AS/NZS 4187: Cleaning, disinfecting and sterilising reusable medical and surgical instruments and equipment and maintenance of associated environments in health care facilities.
  • AS 2853: Enclosures – Temperature-controlled – Performance testing and grading.

A partnership with Synertec will reduce compliance costs and reduce compliance risk. 

  • Validation
  • Data Integrity
  • ERP Validation
  • Temperature Modelling

Validation services

validation services

Validation Capabilities

Synertec is an ISO9001 certified company and therefore we understand what it takes to develop and maintain a compliant quality system and to deliver products that meet client’s needs.

Synertec’s experience and knowledge are centered around a team of dedicated engineers and scientists who not only understand the technology and processes in a wide range of industries but also have hands-on experience in implementing compliant solutions in these industries. 

Based on this extensive experience Synertec’s team can identify and “translate” the applicable regulatory requirements and standards that are best suited to the project and the organisation. 

Once the applicable standards are identified, Synertec can then implement a compliant strategy that is sustainable, risk based, cost-effective, and pragmatic enabling a solution that is the “right fit” for the organisation.

Track Record

Synertec’s areas of expertise include:

  • Development and maintenance of compliant quality systems
  • Continuous improvement planning
  • Risk assessment and risk management
  • Change management
  • Training
  • Audit readiness inspections and remediation planning/execution
  • Process mapping
  • Verification and validation of equipment, systems and processes
  • Design, construction and qualification of cleanrooms and isolation suites

Data Integrity services

secure network concept. isometric 3D render.

Why is Data Integrity Essential?

The ISPE (International Society of Pharmaceutical Engineers) have recently published guidelines on the need for and use of data integrity; Any data that is used to make a decision which will affect product quality, patients and those being administered the products, or is regulated is subject to the requirements stipulated by the ISPE. Both electronic data and paper records of this affected data must comply with these standards.

Synertec’s Solution

With in-house Data Integrity specialists, Synertec can ensure that comprehensive independent data integrity audits are carried out to comply with the ISPE regulations.

This is achieved through client workshops and risk assessments to determine the critical data on your site. 

 Audit checklists which have been developed through our experience in Data Integrity analysis are used to check compliance. A report is generated for our customers detailing Data flow maps and areas of compliance.

If required, Synertec can provide a Data Integrity policy which can ensure that all future critical data will comply with the ISPE standards.

ERP Validation Services

project management planning

ERP Validation Capabilities

Synertec is recognised as an industry leader in all aspects of validation and has an enviable reputation in the validation of Enterprise Resource Planning (ERP) systems. 

In acknowledgement of this, Synertec has delivered technical presentations alongside the TGA, at a number of ISPE seminars on “ERP Validation in a Regulated Environment”. 

Synertec’s knowledge of TGA, FDA and other regulatory requirements has seen Synertec work with organisations such as:

  • Pfizer
  • Baxter
  • CSL
  • Hospira (Mayne Pharma)
  • GlaxoSmithKline
  • Wyeth
  • Cochlear
  • Ventracor
  • ResMed
  • Universal Biosensors
  • Pharmaxis
  • Bayer

Relevant Experience

Synertec is accustomed to validating a wide range of systems for clients and working with various system vendors, including: 

  • Microsoft NAV ERP system at Parnell, Pharmaxis and CathRx in Sydney and Universal Biosensors in Melbourne
  • MAPS, Pfizer’s global Manufacturing Accounting & Planning system, West Ryde
  • De-integration of MAPS at Pfizer, Caringbah, following the acquisition of Pfizer’s Consumer  Health Business by Johnson & Johnson
  • Upgrade to Oracle ERP system, at ResMed
  • Pronto ERP system at Mediherb, Warwick (Queensland)
  • MFG PRO at PanBio, Brisbane
  • JD Edwards ERP system at Symbion, Brisbane
  • SAGE at Agen Medical, Brisbane
  • SAP ERP at Ego Pharmaceuticals, Melbourne, and iNova, Sydney

Synertec appreciates the business imperatives of different organisation structures and cultures and strives to deliver regulatory compliance solutions which are commercially pragmatic.

Temperature Modelling services

temperature modelling services

Temperature Modelling Capabilities

Synertec’s areas of expertise in validating controlled environments (through mapping of temperature, humidity and pressure) include:

  • Autoclaves
  • Incubators
  • Fridges and freezers
  • Hot air ovens
  • Cold rooms
  • Clean rooms

Synertec owns state-of-the-art measurement and calibration instruments to deliver cost-effective qualification solutions. Synertec takes care of the validation process from protocol development, protocol execution and through to the delivery of validation reports and certificates. 

Relevant Experience

Synertec’s experience and systems allow the company to offer cost-effective and time-efficient temperature mapping solutions that are compliant to the following standards: 

  • AS/NZS 4187: Cleaning, disinfecting and sterilising reusable medical and surgical instruments and equipment and maintenance of associated environments in health care facilities.
  • AS 2853: Enclosures – Temperature-controlled – Performance testing and grading.

A partnership with Synertec will reduce compliance costs and reduce compliance risk. 

Kylie Brailsford

Validation & Systems engineering Manager

Contact Kylie for any Validation & Compliance Inquiries