Prefect - Training Management System

21 CFR Part 11 deals with the FDA guidelines on electronic records and electronic signatures. These guidelines, commonly know as Part 11 details the criteria by which electronic signatures and records are deemed to be as reliable as handwritten signatures and paper records.

These guidelines require all companies within the pharmaceutical sector regulated by the FDA to implement controls, including audits, validation systems, and documentation for software and systems involved in processing many forms of data as part of business operations and product development.

The Prefect Training Management System addresses the requirements in the following way:

Part 11 Section 11.10
Ensure authenticity, integrity, and when appropriate confidentiality of electronic records.

• Prefect TMS permits administrators of the system to define accessibility to the system and its features on a user by user basis. A full audit trail is generated when any actions are taking whilst using the system.

Part 11 Section 11.10
Minimize possibility of repudiation by signer.

• All users of the Prefect TMS system have a unique public key, (user name), and private key, (password). This private key must be entered each time a user wishes to sign off a task whether it is to signal a document has been read or a test has been taken. The password is encrypted to enhance security.

Part 11 Section 11.10 i
Determination that persons using the electronic system have been properly trained to perform their assigned tasks.

• Bespoke training programs are developed within the Prefect TMS system for individual users and or groups of employees working within a company to ensure they can use the Prefect TMS system. These training programs are focused on ensuring users can perform the required tasks asked of them when using Prefect TMS.

Part 11 Section 11.10 k
Appropriate controls over system documentation including access to documentation for system operation and revision and change control procedures that documents time-based system modification.

• Prefect TMS provides a closed environment in which only those with the necessary public and private keys can access the system. This coupled with the automated audit trail ensures that user's movements within a system are permanently monitored. Version control privileges for documents, training exams, competency testing and role change are controlled by administrators and recorded in the audit trail, thus ensuring all change control is documented in real time with a time stamp of when actions occurred.

Part 11 Section 11.50 a
Signed electronic records must contain the following data:

• When a user of the system enters the private key, an audit trail with the time and date is generated and stored within the system. The audit trail also provides information on what task was performed that lead to the user entering their private key, such as sign off to indicate a document had been read.

Part 11 Section 11.70
Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records.

• Whilst the audit trail can be viewed by those with the necessary privileges, it and the information collated cannot be altered. Thus the entry of an electronic signature will remain linked to the record as long as the system is in use.

The regulations set forth in this part and in parts 211 contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.

Compliance with 21 CFR Part 210 and Part 211 is aided through the use of the Prefect Training Management Solution in the following ways:

Sub Part B, Section 211.22, d
The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.

• The document library within the Prefect TMS provides the ideal solution for electronic document storage relating to companies needs. The document library provides the ability to create documents and where necessary version control documents and restricts access to view and amend these documents. All document creations, additions and amendments can be distributed to the users through the incorporated public messages function. The provision of the real time audit trail ensures a record of a documents' history is up to date and accessible to auditors at a moments notice

Sub Part B, Section 211.22, d
Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.

Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

• The Prefect TMS allows for bespoke training programs to be developed to provide the necessary training. The system automatically assigns compulsory training tasks and individual training programs can be added as and when needed. In addition this system monitors development through the training program in real time, thus providing the user and administrators with up to the minute data about any employee's development. This promotes an efficient professional development system in which both the company and the trainee advance in a time and cost efficient manner.

This regulation describes Current good manufacturing practice (CGMP) requirements. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labelling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the FDA act.

21 CFR 820 Subpart D
Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following:

• The Prefect TMS document library allows selected users to create documents and distribute them to the necessary users. The documents are date and time stamped following their addition to the library after the document creator has input their electronic signature. The version control function allows for changes to be made to documents thus preventing users from reading or implementing out of date material. All document creations, additions and amendments can be distributed to the users through the incorporated public messages function. The entire process relating to document development, revision and distribution is recorded using the real time audit trail function which runs in the background.

21 CFR 820 Subpart B Sec. 820.25
Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.

• Prefect TMS is designed to meet individual training needs within a given company. The systems flexibility allows an administrator to set up individual training modules for designated users where required. The defined process by which users must follow a training order ensures an accumulation of information and skills suited to a user’s development. Failure to meet the necessary requirements is identified immediately and the user must undergo the training again until such time as they are deemed to be compliant. All training including test failures and the number of attempts required to reach competency are recorded within the system allowing a company to readily identify a users capability and worth to the company.

ISO 9000 is a grouping of standards for quality management systems. ISO 9000 is maintained by the International Organization for Standardization and is administered by accreditation and certification bodies. First published in the late 1980’s the standards originated in manufacturing. However today they are now employed across a wide range of organizations. Whilst ISO compliance is voluntary in many countries, growing legions of customers are moving towards using vendors and suppliers that are ISO-certified. Some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) would include:

• a set of procedures that cover all key processes in the business;
• monitoring processes to ensure they are effective;
• keeping adequate records;
• checking output for defects, with appropriate corrective action where necessary;
• regularly reviewing individual processes and the quality system itself for effectiveness; and
• facilitating continual improvement

ISO 9001:2000 has gained most recognition as it applies to organizations across sectors as this standard focuses on quality management through continued enhancement of quality systems. The Prefect Training Management System helps companies to meet the requirements of ISO 9001:2000 is the following way:

ISO 9000:2000 Clause 4.2.1 to 4.2.4
Relating to the documentation of a quality system. This requirement places importance on the development and control of quality system documents and the maintenance of records relation to the quality system.

• The document library within the Prefect TMS provides the ideal solution for electronic document storage relating to companies needs. The document library provides the ability to create and store documents in a central location relating to company practice and task specific training. The system allows authorised users to amend and subsequently version control documents and restricts access to view and amend documents where applicable. The provision of the real time audit trail ensures a record of a documents' history is up to date and accessible to auditors at a moments notice

ISO 9000:2000 Clause 6.2.1 and 6.2.2
This clause relates to the provision of quality personal with an adequate background and the provision of adequate professional training where required.

• The Prefect TMS allows for bespoke training programs to be developed to provide the necessary training. The system automatically assigns compulsory training tasks and individual training programs can be added as and when needed. In addition this system monitors development through the training program in real time, thus providing the user and administrators with up to the minute data about any employee's development. This promotes an efficient professional development system in which both the company and the trainee advance in a time and cost efficient manner.

ISO 13485 a standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A fundamental difference, however, is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained.

Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to EEC-decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The result of a positive assessment is the authorisation for the CE-identification and the permission to sell the high quality medical device in the European Union.

ISO 13485 Clause 4
Relating to the documentation of a quality system. This requirement places importance on the development and control of quality system documents and the maintenance of records relation to the quality system.

• The document library within the Prefect TMS provides the ideal solution for electronic document storage relating to companies needs. The document library provides the ability to create and store documents in a central location relating to company practice and task specific training. The system allows authorised users to amend and subsequently version control documents and restricts access to view and amend documents where applicable. The provision of the real time audit trail ensures a record of a documents’ history is up to date accessible to auditors at a moments notice

ISO 13485 Clause 6.1 & 6.2.2
This clause relates to the provision of quality personal with an adequate background and the provision of adequate professional training where required.

• The Prefect TMS allows for bespoke training programs to be developed to provide the necessary training. The system automatically assigns compulsory training tasks and individual training programs can be added as and when needed. In addition this system monitors development through the training program in real time, thus providing the user and administrators with up to the minute data about any employee’s development. This promotes an efficient professional development system in which both the company and the trainee advance in a time and cost efficient manner.

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. Facilities performing laboratory tests on human samples must comply with CLIA to obtain a certificate from the department of Health and Human Services. In total, CLIA covers approximately 189,000 laboratory entities predominantly located in the United States of America

CLIA Section 493.1200a
Each laboratory that performs non-waived testing must establish and maintain written policies and procedures that implement and monitor quality systems for all phases of the total testing process (that is, preanalytic, analytic, and post analytic) as well as general laboratory systems.

CLIA Section 493.1445e15
Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and post analytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results.

• The document library within the Prefect TMS provides the ideal solution for electronic document storage relating to a laboratories needs. The document library provides the ability for the laboratory supervisor/manager to create and store, (in a centralised location), necessary documents relating to SOP’s, policies and individual duties. The system allows authorised users to amend and subsequently version control documents and restricts access to view and amend documents where applicable. The provision of the real time audit trail ensures a record of a documents’ history is up to date accessible to auditors at a moments notice.

CLIA Section 493.1200b
Each of the laboratory's quality systems must include an assessment component that ensures continuous improvement of the laboratory's performance and services through ongoing monitoring that identifies, evaluates and resolves problems.

CLIA Section 493.1445
Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results.

• The Prefect TMS allows for bespoke training programs to be developed to provide the necessary training for groups of staff or individuals where necessary. The system automatically assigns compulsory training tasks and individual training programs can be added as and when needed. In addition this system monitors development through the training program in real time, thus providing the user and administrators with up to the minute data about any employee’s development. Failure to meet the necessary requirements is identified immediately and the user must undergo the training again until such time as they are deemed to be compliant. All training including test failures and the number of attempts required to reach competency are recorded within the system allowing a supervisor to readily identify a user’s competency to undertake tasks unaided. Typically the system is set up in a manner that users must show a competency level 1 as a result of reading documents and passing both the examinations and manual skill competency tests.