Medical Device Manufacturers and CFR21 Part 11

CFR21 Part 11 is a part of the Code of Regulations, Title 21, which has established the regulations for electronic signatures and records for the United States Food and Drug Administration. Any company that uses electronic systems for signature control and documents must be compliant to CFR21 Part 11. This shows that the documents in electronic form are authentic. Regulations also provide for the confidentiality of these electronic records.

Medical device businesses must comply with the guidelines presented in this regulatory landscape. Basically, software validation is required in addition to validation in the design and manufacturing of medical devices. Computer systems must be using software that ensures that these important compliance regulations are being met.

Technology continues to advance in the medical device field every day and it’s important to have digitalization of all compliance records and documents and the automation of the processes involved. Systems must be developed that understand the validation requirements of CFR21 Part 11.

The compliance regulations have been created to keep the integrity of the data systems safeguarded while at the same time ensuring the validity and the safety of electronic signatures. Medical devices rely on the assurance of data integrity.

Companies must maintain specified records in a secured fashion and then submit data as needed to the FDA as part of the overall compliance. Validation for Part 11 is required for systems that modify, create, maintain, transmit or retrieve electronic records.

The computer software system that you use must be chosen based on the input it will have on the integrity, reliability, city, availability and authenticity of the signatures and records you’ll be keeping. For a free demo of the best compliance software available on the market for medical device manufacturers please visit today.


The Canadian Society for Medical Laboratory Science “CSMLS” is again hosting their annual conference “LABCON 2019” this year being held at the Fredericton Convention Centre, Fredericton, New Brunswick, Ontario May 24th to May 26th 2019. The convention center is located in the heart of the city and is close to the famous St John River.
Fredericton a maritime community is dominated by the St John River which bisects the capitol and is the dominant feature of the city. Named for Prince Frederick of York, it is a youthful city due to the two large universities and is vibrant with art, culture and education. Also there are many bars, restaurants and coffee houses as well as art galleries, museums and music venues as befitting for such an historic city.

The mission statement of CSMLS is to advance the medical laboratory profession through certification, education and advocacy and they adhere to the values of integrity, accountability, respect and commitment. The yearly meeting is an exciting gathering from all across Canada of laboratory professionals, supervisors, technicians, managers, directors and educators reconnecting or meeting anew to explore new technologies and procedures and to benefit from the efforts of CSMLS.

“LABCON” offers the opportunity for professionals to increase their expertise with several hands-on and in-depth workshops. This year they are hosting a large number of topics over the four days of the conference. Many of the presentations this year are focused on quality practices and maintaining high standards in the laboratory and also focusing on accountability. Topics are being covered in many of the laboratory disciplines by a large number of presenters.

This year the Management Intensive Program focuses on the “Management of others in the Lab.”

Some of the more general topics this year include:

  1. Lab Management Transition-Big Bang Theory – Rich Bak MLT
  2. Stick with the Turkey you know – Christine Bruce BHA, MLT, CLQM, LSSBB
  3. Blood bank? This is trauma. We are activating the MTP – Nicole Caldwell Bsc MLT
  4. Twin placental pathology – Are they identical? – Cassie Buick PA
  5. Fluid morphology – Jonaki Manna MD FRCPSC

There is also a social aspect to the conference with a welcoming reception, opening ceremonies, and an exhibitor’s reception. On Saturday the President hosts a reception in the Beaverbrook Art Gallery. The conference will also host the CSMLS annual general meeting and an open forum.

As well as laboratory professionals attending a large number of exhibitors will also be attending “LABCON 2019” giving attendees a chance to see and experience new products and services relevant to their field. Paradigm 3 Compliance Management Software will again exhibit at the event, and they have been attending for the past several years and have had the chance to interact with many of Canada’s laboratory professionals. Paradigm 3 aids laboratories to maintain their policies, procedures and compliances in an efficient, easy to manage and cost effective way.

Cannabis test labs and ISO 17025 accreditation

Around the world, ISO—the International Organization for Standardization—is synonymous with standards, and that’s just what the cannabis industry needs. In analytical labs, ISO is like the Good Housekeeping Seal of approval. It means that someone with authority endorses what a lab is doing and, how it does it. Although ISO has published 21,613 International Standards, the most common one sought by cannabis analytical labs is ISO/IEC 17025. According to ISO, this standard “specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling.”

Adequate safety testing for Cannabis is an attainable goal. Many of the existing Cannabis testing laboratories are now well-staffed and well-funded. Competent laboratories will have little difficulty meeting the accreditation criteria used by both the private sector and the governmental regulatory bodies that oversee the laboratories that test our food, soil, medicines, and drinking water. These criteria are consolidated in the International Organization for Standardization (ISO) guidelines known as ISO 17025 (General requirements for the competence of testing and calibration laboratories), and they are clear, effective, and universally accepted.

The testing of Cannabis must be performed by laboratories that have been able to demonstrate their competence through well-established accreditation mechanisms. Accreditation is a formal recognition by an authoritative third-party of a laboratory’s competence to perform specific tests. This accreditation infrastructure is well established by the mutual recognition arrangement (MRA) among accreditation bodies through the International Laboratory Accreditation Cooperation (ILAC). ILAC functions as a forum for harmonizing laboratory and inspection body accreditation procedures and policies, thus promoting accreditation as a mechanism to enhance confidence in testing and inspection facilities.

Multiple resources are also available to assist laboratories in preparing for accreditation. ISO 17025 consultants can be hired to perform a gap analysis on their quality system and various training courses are offered by Accreditation Bodies on the basics of accreditation, internal auditing, root cause analysis, etc.

Scope of Accreditation

ISO 17025 does not specify what methods a laboratory uses. Laboratories must themselves define the methods included within their scope of accreditation. In order for a Cannabis testing laboratory to be fully accredited across all of its relevant methodologies, its scope must include identification and quantitation of those components and potential contaminants relevant to public health. These will fall into the following categories.

  1. Pesticides. These should be tested for using methods based on AOAC Official Method 2007.01 (or on more effective methods when they become available) with a state-mandated subset of the chemicals specified therein. The Cannabis Safety Institute white paper on pesticides will specify a list that laboratories should be required to test for.
  2. Cannabinoids, including, at a minimum, THC, THCA, CBD, and CBDA. This must include extraction methods for dealing with the variety of matrices found in edible products.
  3. Microbiology testing: detection and quantitation of all relevant bacterial and fungal species specified in state guidelines.
  4. Volatile Organic Compounds (VOCs), often referred to as residual solvent testing (for extracts made with hydrocarbon or organic solvents).
  5. Water Activity (a measure of water available to support microbial growth; not substitutable by moisture content measurements).

Most established Cannabis laboratories also test for plant compounds known as terpenes. These are not considered harmful, but in view of their increasing importance and the increasing evidence that they contribute significantly to the characteristics of each Cannabis variety, laboratories should be expected to add these tests to their scope. Cannabis testing laboratories should, of course, also include in their scope any other assay required under state law.


Third-party laboratory accreditation can help to demonstrate that a lab is structured properly, that it has adequate documentation of all of its procedures and quality assurance methods, and that it follows these procedures and methods. Additionally the laboratory must ensure is that it has its test methods in control. One means to achieve this is through the use of proficiency testing using blinded samples provided for analysis. All ISO 17025 accredited laboratories must participate in proficiency testing activities when they are relevant and available.

Accreditation to the internationally accepted ISO 17025 standard for testing laboratories, in combination with a rigorous proficiency testing program, is the proven approach for ensuring the quality and reliability of the vast majority of analytical cannabis laboratories. Paradigm 3 is a compliance management software that manages various facets of your ISO 17025 system such as document control, corrective action, training and competency and calibration.