Section 691-5-7 - Recordkeeping RequirementsSection 7.1 - Recordkeeping Requirements A. The cannabis testing facility must maintain analytical records to demonstrate to the CDC the following: the analyst's name; date of analysis; approver of the certificate of analysis and relevant data package; the test method; and the materials used. (1) Cannabis testing facility recordkeeping may be on paper or on electronic, magnetic or optical media and must be stored in such a way that the data are readily retrieved when requested by the OCP or the CDC.(2) If the cannabis testing facility recordkeeping is not on paper, the cannabis testing facility must be able to produce them in hard copy for OCP or the CDC, upon request.(3) All cannabis testing facility records must be kept for a minimum of five years.(4) OCP and the CDC must be allowed access to all electronic data, including standards records, calibration records, extraction logs, cannabis testing facility notebooks and all other cannabis testing facility-related documents listed below.B. The cannabis testing facility must maintain all documents, forms, records and standard operating procedures associated with the cannabis testing facility's methods, including without limitation the following:(1) Current personnel qualification, training and competency documentation, including, but not limited to, resumes, training records, continuing education records, analytical proficiency testing records and demonstration of capability records or attestations for cannabis testing facility work;(2) Method verification and validation records, including records relating to method modification; method detection limit and reporting limit determination; ongoing verification, such as proficiency testing; and reference material analysis;(3) Quality control and quality assurance records, including the cannabis testing facility's quality assurance manual and control charts with control limits;(4) Any sample collection records the testing facility requires licensees to submit with every sample collected and submitted for mandatory testing, if applicable in accordance with the testing facility's quality system;(5) Chain of custody records, including chain of custody forms, applicable field sample logs, and record relating to sample receipt, sample descriptions, sample rejections, laboratory information management system (LIMS), sample storage, sample retention and disposal;(6) Records relating to purchasing and supply, purchase requisitions, packing slips, and supplier records;(7) Certificates of analysis;(8) Records of equipment installation, maintenance and calibration, including date; name of person performing the installation, calibration or maintenance; and description of the work performed; internal maintenance logs, pipette calibration records, balance calibration records, working and reference mass calibration records and daily verification-of-calibration records;(9) Customer service records, including include contracts with customers, customer request records, transaction records and customer feedback;(10) Records related to the handling of complaints, nonconformities, and corrective action, including records of internal investigations, customer notifications and implementation of corrective action plans;(11) Internal and external audit records, including audit checklists, standard operating procedures and audit observation and findings reports, including the date and name of the person or persons performing the audit;(12) Management review records, including technical data review reports and final management review reports, with review date and the identity of the reviewer;(13) Cannabis testing facility data reports, data review and data approval records, which must include the analysis date and the name of the analysts, including instrument and equipment identification records, records with unique sample identifiers, analysts' cannabis testing facility notebooks and logbooks, traceability records, test-method worksheets and forms, instrumentation-calibration data and test-method raw data;(14) Proficiency testing records, including the proficiency test schedule, proficiency test reports, and records of data review, data reporting, nonconforming work, corrective action, quality control and quality assurance;(15) Electronic data, backed-up data, records regarding the protection of data and cannabis testing facility security records, including raw unprocessed instrument output data files and processed quantitation output files, electronic data protocols and records, authorized personnel records and cannabis testing facility access records and surveillance- and security-equipment records;(16) Traceability, raw data, standards records, calibration records, extraction logs, reference materials records, analysts' cannabis testing facility notebooks and logbooks, supplier records and all other data-related records; and(17) Cannabis testing facility contamination and cleaning records, including autoclave records, acid wash logs and records and general cannabis testing facility safety and chemical-hygiene protocols.C. If the records are missing or incomplete, or if the cannabis testing facility does not produce the records for OCP or the CDC upon request, OCP or the CDC may take disciplinary action against the cannabis testing facility. The cannabis testing facility shall have 7 calendar days from issuance of request to respond.Section 7.2 - Data Package Requests A. The cannabis testing facility must retain the entire data package for each sample the cannabis testing facility analyzes for a minimum of five years and make available to OCP or the CDC upon request. The data package must contain, at a minimum, the following information:(1) The name and address of the cannabis testing facility that performed the analytical procedures;(2) Any sample collection records required by the testing facility's quality system, if applicable, for each batch of cannabis, cannabis concentrate or cannabis product submitted for mandatory testing;(3) The names, functions and signatures of the cannabis testing facility personnel that performed sample preparation and analyses and reviewed and approved the data;(4) All sample and batch quality control sample results;(5) Raw data for each sample;(6) Instrument raw data, if any;(7) Instrument test method with parameters;(8) Instrument tune report;(9) All instrument calibration data;(10) Test method worksheets or forms used for sample identification, characterization and calculations, including chromatograms, sample preparation worksheets and final datasheets;(11) Quality control report with worksheets, forms or copies of cannabis testing facility notebook pages containing pertinent information related to the identification and traceability of all reagents, reference materials and standards used for analysis;(12) Analytical batch sample sequences;(13) The field sample log and the chain of custody form; and(14) The certificate of analysis created, as required under this rule.B. The cannabis testing facility must make the data package for a sample available.C. After the data package has been compiled, the facility director or QAO must:(1) Review the analytical results for technical correctness and completeness;(2) Verify that the results of each analysis carried out by the cannabis testing facility are reported accurately, clearly, unambiguously and objectively and that the measurements are traceable; and(3) Approve the measurement results by signing and dating the data package prior to release of the data by the cannabis testing facility.D. The testing facility must submit requested sample results to the CDC in an electronic format acceptable to the Maine Cannabis Certification Program (MMCP). This includes the reporting of all required laboratory quality control information and associated acceptance limits.Section 7.3 - Electronic Data A. Testing facilities must store all raw unprocessed instrument output data files and processed quantitation output files on some form of electronic, magnetic or optical media. The cannabis testing facility must allow access to these records for inspection and audit.B. Testing facilities must install, manage and maintain password-protection for electronically stored data, including any certificate of analysis.