GMP Compliance Statement

Lean-Q System’s Quality Objectives

The critical objective for developing Lean-Q system is to expedite the completion of quality investigations quickly and reliably and to generate electronic GMP records which are accurate, secured and permanent.

Lean-Q quality system software has been carefully designed and developed to facilitate process improvements significantly by providing easy access to complete quality concerned investigations electronically and to maintain documented evidence for future analysis. Lean-Q system can directly contribute to improve the overall product quality as well as to increase the compliance of regulatory requirements.

Many Regulatory agencies have made significant efforts to guide their life science industries on the development and maintenance of validated electronic systems which can be used to generate GMP records electronically and keeping those records in a safe and reliable manner.

One of the most popular guidelines in this respect is FDA, 21 CFR Part 11 (Electronic Signatures and Records). In this guidance document, FDA has made specific recommendations for manufacturing businesses involving in producing therapeutic products on how to develop, modify, maintain, archive, retrieve and transmit electronic records while operating the business under a GMP license.

The requirements set forth in 21 CFR part 11 also include certain provisions of the Current Good Manufacturing Practice regulations (21 CFR Part 211), the Quality System regulation (21 CFR Part 820) and the Good Laboratory Practice for Non-clinical Laboratory Studies regulations (21 CFR Part 58).

Summary of 21 CFR Part 11 Requirements

The rules and recommendations for maintenance of electronic records governed by 21 CFR Part 11 can be summarized and interpreted as follows. Business should take adequate steps to:

  • Limiting the electronic system access to authorized individuals
  • Use of operational system checks of the computerized systems
  • Perform authority checks for using those computerized systems
  • Use of device check
  • Determine that persons who develop, maintain or use electronic systems have the education, training and experience to perform their assigned tasks
  • Establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures.
  • Appropriate controls over systems documentation
  • Controls for open systems corresponding to controls for closed systems.

21 CFR Part 11 Also Defines

  • Records that are required to be maintained can be done either in electronic format in place of paper format or in electronic format in addition to paper format and must be relied on to perform regulated activities.
  • Business should exercise cautions and risk based approach in validating their electronic systems to the extent to ensure the accuracy, reliability, integrity, availability and authenticity of the required records and signatures.
  • Persons working for the business must comply with the requirements related to maintenance of electronic documentation with an audit trail which should demonstrate the persons name, position, time / date stamping of an electronic signature and the sequence of events are maintained to ensure changes to a record do not obscure previous entries. The availability of an audit trail is to ensure the trustworthiness and reliability of an electronic record.
  • Business should be able to produce copies of electronic records to be held in common portable formats when records are kept in those formats and business should be able to provide an investigator reasonable and useful access to the records during an inspection.
  • Businesses must be able to provide adequate protection of their electronic records and be capable of retrieving those records accurately and readily throughout the record retention period.

Typical Quality Investigation Steps:

A typical quality concern investigation should include at least the followings:

  • Brief description of the subject to which problem relates
  • Description of the incident/problem/deviation
  • Documentation of probable causes of the incident
  • Documentation of investigation findings relative to each probable cause
  • Documentation of evaluation of each probable cause
  • Elaboration on actual or suspect cause(s)
  • Documentation of the investigator’s logic; citation of the data and information being used
  • Evaluation and documentation of whether other batches, etc are potentially involved
  • Documentation of conclusions and rationales
  • Outline of corrective and preventive actions; short term & long term
  • Outline of impact on status of disposition of batches, etc

Lean-Q Software Compliance with GMP Regulations:

Lean-Q system has been validated for use in GMP licensed facility as well as compliant with the mandatory regulatory requirements due to the following built in features:

  • Lean-Q program has the built in functionality to login securely only by its authorized users. A strong identification and password algorithm must be needed to log into the program.
  • Lean-Q has multiple layers of permission levels among the users. Such as system Administrator, Entry level, Reviewer and Approver users to ensure specific tasks can only be performed by authorized persons according to their positions and responsibilities. (Applicable for integrated version of Lean-q system)
  • Each step of an investigation has to be documented in the Lean-Q electronic investigation forms according their sequence of events. For example, record initiation > investigation > record review > record approval > and record closure. Lean-Q is designed to reflect the real-time sequential workflow of an investigation by not allowing the user to perform a task randomly which can break the logical sequence. (Applicable for integrated version of Lean-q system)
  • In Lean-Q system, all new entries and amendments to old entries during the investigation process must have to be saved after an electronic signature being executed by the authorized persons. All electronic signatures accompany the person’s name, position title, date, time and activity comment. The signature and entry comments are shown on both the live record and searched reports.
  • Lean-Q system does not allow the users to leave or skip a field blank (which has significance on the investigation workflow) in order to comply as a GMP document. (Applicable for integrated version of Lean-q system)
  • The Lean-Q software has been designed with numerous validation rules which guide the users to complete a task comply sequentially and to comply with GMP. An automated Audit system checks the entries on the form and prompts the user if any of those validation rules are violated during the course of an investigation. Lean-Q system is able to recommend the users where the rules are broken and necessary steps to follow in order to correct those. (Applicable for integrated version of Lean-q system)
  • Lean-Q system does not allow users to delete or amend a comment or investigation step without being passed through proper record change management system.
  • Lean-Q system does not allow the administrator to delete an user from the system who no longer works for the organization. This is to ensure the compliance of record retention provision described in the FDA regulation 21 CFR Part 11.
  • The Lean-Q software database is hosted and published from secured servers which has restricted access only by the experienced developers to ensure the database integrity. (Applicable for integrated version of Lean-q system)
  • The Lean-Q software database has the option to backup multiple times in each day as the contingency to disaster recovery. (Applicable for integrated version of Lean-q system)
  • Lean-Q software is able to generate GMP records as well as analyzing reports based on the true data and is able to generate copies of the reports which can be stored into portable electronic devices.