RYAN BERTRAM


“Nothing in this world can take the place of persistence. Talent will not: nothing is more common than unsuccessful men with talent. Genius will not; unrewarded genius is almost a proverb. Education will not: the world is full of educated derelicts. Persistence and determination alone are omnipotent." -Calvin Coolidge

After a 12 year-old Ryan visited the Corvette factory in Bowling Green, Kentucky, he knew he wanted to part of how America makes things. With continued interest in the art and science of manufacturing, Ryan pursued his Bachelors in International Business at Calvin College. After graduating, he realized his dream of working with manufacturing by holding client relations positions throughout the manufacturing industry. At Malisko, Ryan enjoys bringing together the right people for the right job to tackle complex projects, and helping to bring the total solution to the client's plant floor.

Personal Passion
He likes spending time with his family and helping his children to blaze their own trail.

Dream Job
Build houses for Habitat for Humanity

Interesting Fact
He secretly likes the handy-man "fix-it" list his wife gives him every weekend. (Shhh! don't tell her that though!)

OUR APPROACH

ELECTRONIC RECORDS

For manufacturers operating in FDA-regulated industries, such as life sciences and pharmaceutical, Title 21 CFR Part 11 mandates the requirements of automation systems for electronic records and electronic signatures. We have implemented numerous automated production systems over the years meeting Part 11 and can help you with completing your journey to Part 11 compliance of your manufacturing automation systems.

ELECTRONIC RECORDS

For manufacturers operating in FDA-regulated industries, such as life sciences and pharmaceutical, Title 21 CFR Part 11 mandates the requirements of automation systems for electronic records and electronic signatures. We have implemented numerous automated production systems over the years meeting Part 11 and can help you with completing your journey to Part 11 compliance of your manufacturing automation systems.

WHAT PART 11 REQUIRES

Title 21 CFR Part 11 places data integrity, security and audit trail requirements on open and closed systems. A closed system is an environment where system access is controlled by the persons responsible for the content of electronic records on the system. An open system is an environment where it’s not. Most computer-based Control, Data Acquisition and Reporting Systems used in manufacturing are closed systems.

Unsure about CFR Part 11 Requirements and Guidance?

WHAT PART 11 REQUIRES

Title 21 CFR Part 11 places data integrity, security and audit trail requirements on open and closed systems. A closed system is an environment where system access is controlled by the persons responsible for the content of electronic records on the system. An open system is an environment where it’s not. Most computer-based Control, Data Acquisition and Reporting Systems used in manufacturing are closed systems.

Unsure about CFR Part 11 Requirements and Guidance?

HOW WE SUCCESSFULLY ENSURE FULL COMPLIANCE

We leverage our extensive experience and automation expertise to ensure that your system meets Part 11 requirements for:

  • Physical and Logical Security
  • Standard Operating Procedures (SOPs) for ERs and ESs
  • Data Integrity and Traceability
  • Validation and Compliance

We provide related SCV documentation. When we complete our work, you have a system that complies with.

HOW WE SUCCESSFULLY ENSURE FULL COMPLIANCE

We leverage our extensive experience and automation expertise to ensure that your system meets Part 11 requirements for:

  • Physical and Logical Security
  • Standard Operating Procedures (SOPs) for ERs and ESs
  • Data Integrity and Traceability
  • Validation and Compliance

We provide related SCV documentation. When we complete our work, you have a system that complies with.

HOW WE MEET SECURITY REQUIREMENTS

REQUIREMENT: Employ procedures and controls designed to ensure the authenticity, integrity, and confidentiality of electronic records.
OUR SOLUTION: We develop Standard Operating Procedures (SOPs) to support the use of electronic records in the regulated environment. We validate the procedures and system. The validation follows an established System Life Cycle (SLC) methodology; such as GAMP V (ISPE).


REQUIREMENT: Limit system access to authorized individuals only.
OUR SOLUTION: We specify limited physical access to the servers and data storage devices. We also specify robust Windows Security. We ensure user account policies implement password aging, minimum password length, password uniqueness, and account lockout after a reasonable number (typically 5) of unsuccessful login attempts. And we configure each Operator Node to use ‘User Login’ Timeout.

HOW WE MEET SECURITY REQUIREMENTS

REQUIREMENT: Employ procedures and controls designed to ensure the authenticity, integrity, and confidentiality of electronic records.
OUR SOLUTION: We develop Standard Operating Procedures (SOPs) to support the use of electronic records in the regulated environment. We validate the procedures and system. The validation follows an established System Life Cycle (SLC) methodology; such as GAMP V (ISPE).


REQUIREMENT: Limit system access to authorized individuals only.
OUR SOLUTION: We specify limited physical access to the servers and data storage devices. We also specify robust Windows Security. We ensure user account policies implement password aging, minimum password length, password uniqueness, and account lockout after a reasonable number (typically 5) of unsuccessful login attempts. And we configure each Operator Node to use ‘User Login’ Timeout.

HOW WE MEET COMPLIANCE FOR ELECTRONIC RECORDS (ERs) & ELECTRONIC SIGNATURES (ESs)

REQUIREMENT: Generate accurate and complete copies of records in both human-readable and electronic format. Protect records to enable their accurate and are ready-retrieval throughout the records retention period.
OUR SOLUTION: We help develop SOPs to ensure that records are securely retained for an appropriate duration of time.


REQUIREMENT: Implement secure, computer-generated, time-stamped audit trails.
OUR SOLUTION: We specify Microsoft Windows Clock Synchronization among all computers and servers in the application.


REQUIREMENT: Ensure that signed Electronic Records (ER) contain the following:

  • Printed name of the signer
  • Date and time when the signature was executed
  • Meaning of signature – i.e. review, approval, responsibility, authorship. Ensure these requirements also apply to ANY human-readable form of the ER – both the hard-copy printout and electronic display.

OUR SOLUTION: We make sure the audit trails includes:

  • Date and time stamp
  • Node of origination
  • Operator’s User Name
  • Action Taken
  • What Parameter (Tag Name) Acted Upon
  • Message Type

REQUIREMENT: Ensure Electronic Signatures (ES) and Hand-Written Signatures executed to ERs are linked to their respective ERs in such a way as to ensure that signatures cannot be excised, copied, or otherwise transferred to falsify an ER by ordinary means.
OUR SOLUTION: We help develop SOPs to prevent unauthorized access to the Relational Database containing the Audit Trail File. We also validate the procedures and system.

HOW WE MEET COMPLIANCE FOR ELECTRONIC RECORDS (ERs) & ELECTRONIC SIGNATURES (ESs)

REQUIREMENT: Generate accurate and complete copies of records in both human-readable and electronic format. Protect records to enable their accurate and are ready-retrieval throughout the records retention period.
OUR SOLUTION: We help develop SOPs to ensure that records are securely retained for an appropriate duration of time.


REQUIREMENT: Implement secure, computer-generated, time-stamped audit trails.
OUR SOLUTION: We specify Microsoft Windows Clock Synchronization among all computers and servers in the application.


REQUIREMENT: Ensure that signed Electronic Records (ER) contain the following:

  • Printed name of the signer
  • Date and time when the signature was executed
  • Meaning of signature – i.e. review, approval, responsibility, authorship. Ensure these requirements also apply to ANY human-readable form of the ER – both the hard-copy printout and electronic display.

OUR SOLUTION: We make sure the audit trails includes:

  • Date and time stamp
  • Node of origination
  • Operator’s User Name
  • Action Taken
  • What Parameter (Tag Name) Acted Upon
  • Message Type

REQUIREMENT: Ensure Electronic Signatures (ES) and Hand-Written Signatures executed to ERs are linked to their respective ERs in such a way as to ensure that signatures cannot be excised, copied, or otherwise transferred to falsify an ER by ordinary means.
OUR SOLUTION: We help develop SOPs to prevent unauthorized access to the Relational Database containing the Audit Trail File. We also validate the procedures and system.

HOW WE MEET COMPLIANCE FOR STANDARD OPERATING PROCEDURES (SOPs)

REQUIREMENT: Establish and adhere to written policies that hold individuals accountable and responsible for actions initiated under their ESs to deter record and signature falsification.
OUR SOLUTION: We help develop SOPs to support the use of ERs and ESs in your Regulated Environment. And we validate the policies and system.


REQUIREMENT: Establish and adhere to written policies that:

  • Maintain the uniqueness of each combined identification code and password
  • Periodically check, recall, or revise ID code and password issuances
  • Follow loss management procedures to electronically de-authorize stolen, missing, or compromised tokens, cards, or other devices
  • Use transaction safeguards to prevent unauthorized use of IDs and PWs
  • Conduct initial and periodic device testing

OUR SOLUTION: We employ one of two possible scenarios. Use current, robust SOPs already in place via our clients’ IT/IM departments; or develop new SOPs to control and properly maintain the identification names and passwords of individuals. And we validate the policies and systems with Qualification protocols.

HOW WE MEET COMPLIANCE FOR STANDARD OPERATING PROCEDURES (SOPs)

REQUIREMENT: Establish and adhere to written policies that hold individuals accountable and responsible for actions initiated under their ESs to deter record and signature falsification.
OUR SOLUTION: We help develop SOPs to support the use of ERs and ESs in your Regulated Environment. And we validate the policies and system.


REQUIREMENT: Establish and adhere to written policies that:

  • Maintain the uniqueness of each combined identification code and password
  • Periodically check, recall, or revise ID code and password issuances
  • Follow loss management procedures to electronically de-authorize stolen, missing, or compromised tokens, cards, or other devices
  • Use transaction safeguards to prevent unauthorized use of IDs and PWs
  • Conduct initial and periodic device testing

OUR SOLUTION: We employ one of two possible scenarios. Use current, robust SOPs already in place via our clients’ IT/IM departments; or develop new SOPs to control and properly maintain the identification names and passwords of individuals. And we validate the policies and systems with Qualification protocols.

HOW WE MEET COMPLIANCE FOR SYSTEM INTEGRITY AND TRACEABILITY

REQUIREMENT: Use operational system checks to enforce permitted sequencing of steps and events.
OUR SOLUTION: We typically recommend logging all Parameter (Recipe) downloads, sequence events, and operator actions in a secure SQL database.


REQUIREMENT: Use device checks to determine the validity and integrity of the source of data input or operation instructions.
OUR SOLUTION: We verify sources of data input, such as operator stations (thin clients) as part of the validation process, restrict access to program code only by authorized technical support personnel, and deploy recipe/formula/operational procedures to a secure server computer environment.


REQUIREMENT: Ensure revision and change control procedures to maintain an audit trail that documents time-sequenced developments and modifications of system documentation.
OUR SOLUTION: We typically cover this requirement with the IQ and OQ Validation Protocols, Change Control procedures and existing IT/IM and Compliance SOPs.

HOW WE MEET COMPLIANCE FOR SYSTEM INTEGRITY AND TRACEABILITY

REQUIREMENT: Use operational system checks to enforce permitted sequencing of steps and events.
OUR SOLUTION: We typically recommend logging all Parameter (Recipe) downloads, sequence events, and operator actions in a secure SQL database.


REQUIREMENT: Use device checks to determine the validity and integrity of the source of data input or operation instructions.
OUR SOLUTION: We verify sources of data input, such as operator stations (thin clients) as part of the validation process, restrict access to program code only by authorized technical support personnel, and deploy recipe/formula/operational procedures to a secure server computer environment.


REQUIREMENT: Ensure revision and change control procedures to maintain an audit trail that documents time-sequenced developments and modifications of system documentation.
OUR SOLUTION: We typically cover this requirement with the IQ and OQ Validation Protocols, Change Control procedures and existing IT/IM and Compliance SOPs.

HOW WE MEET VALIDATION & DOCUMENTATION COMPLIANCE

REQUIREMENT: Validate the system to ensure the accuracy, reliability, and consistency of intended performance while providing the ability to discern invalid or altered records.
OUR SOLUTION: We develop and execute IQ and OQ Validation Protocols creating documented evidence of compliance with Title 21 CFR Part 11.


REQUIREMENT: Ensure adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.
OUR SOLUTION: We help align SOPs to cover this requirement.

HOW WE MEET VALIDATION & DOCUMENTATION COMPLIANCE

REQUIREMENT: Validate the system to ensure the accuracy, reliability, and consistency of intended performance while providing the ability to discern invalid or altered records.
OUR SOLUTION: We develop and execute IQ and OQ Validation Protocols creating documented evidence of compliance with Title 21 CFR Part 11.


REQUIREMENT: Ensure adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.
OUR SOLUTION: We help align SOPs to cover this requirement.

MORE ABOUT OUR COMPLIANCE METHODS

Our Validation efforts help ensure you establish and adhere to qualification criteria for persons who develop, maintain or use the ER/ES system and ensure teams have education, training, and experience to perform their assigned tasks.

We help ensure that your closed computer systems have a collection of technological and procedural controls to protect data within your system. We help make sure that safeguards are in place so your electronic records are authentic, incorruptible, and confidential.

We provide accurate record generation so that records entered into the system are completely retrievable without unexpected alteration or unrecorded changes. We test this during validation by verifying that records entered into your system are accurately displayed and accurately exported from your system with no adulteration.

And we provide the related validation documentation that you need as evidence that your manufacturing automation system meets Part 11 compliance.

MORE ABOUT OUR COMPLIANCE METHODS

Our Validation efforts help ensure you establish and adhere to qualification criteria for persons who develop, maintain or use the ER/ES system and ensure teams have education, training, and experience to perform their assigned tasks.

We help ensure that your closed computer systems have a collection of technological and procedural controls to protect data within your system. We help make sure that safeguards are in place so your electronic records are authentic, incorruptible, and confidential.

We provide accurate record generation so that records entered into the system are completely retrievable without unexpected alteration or unrecorded changes. We test this during validation by verifying that records entered into your system are accurately displayed and accurately exported from your system with no adulteration.

And we provide the related validation documentation that you need as evidence that your manufacturing automation system meets Part 11 compliance.

INDUSTRIAL AUTOMATION FOR RESULTS

In our more than 20 years of helping manufacturers, we’ve intelligently applied automation for hundreds of companies across a wide range of industries. And we’ve earned repeat business from 90 percent of our clients.

Have a question or do you want more output, fewer lost batches and better reports? We can show you how to improve your production and maximize your successes through industrial automation.

500 N BROADWAY SUITE 1600 ST LOUIS, MO 63102

(314) 621-2921

500 N BROADWAY
SUITE 1600
ST LOUIS, MO 63102

(314) 621-2921

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