The benefits of data-driven quality management software in pharma can boost all pharma efficiency. Needs further understanding of a tester’s roles while testing pharmaceutical applications and meeting the criteria for Software Testing in the Pharmaceutical Industry.
Domain knowledge is key to testing a pharmaceutical application. Unlike other software systems, the pharmaceutical industry deals directly with the health and well-being of people at large undergoing specific ailments including physical and psychological trauma. Any error inputs in data or patient treatment plans in the system can potentially lead to serious and fatal health issues. Therefore, it is essential for the software test team to be familiar with all the critically requisite business scenarios.
All pharmacy systems are highly health-critical applications. The software systems not displaying a clinical warning for drug allergy reactions, might cause severe health repercussions for all the patients. Therefore, testers need to reconfigure all patient and drug information so that it performs all the plausible clinical checks prior to allocations.
Software testers must pay attention to all the numbers being used in the pharmacy system; like the dose quantity specified by the prescriber. Any errors in dosage can lead to severe health issues causing an unintentional overdose of medication causing certain possibly fatal side effects. In addition, testers should also focus on the system functionality which allows the system to auto-populate dosages via auto generated SMS, email, or phone call for patient medication.
Most pharmacists use keyboard shortcuts for daily work expeditions. A comprehensive list of keyboard shortcuts should be prepared prior to the start of the QA testing phase and should be shared with all the stakeholders and the software test team.
QA Testers must be provided prior information about real-time drugs and diseases which cause interaction or contraindication between two drugs or create an allergic reaction with a patient’s lifestyle or medical history. A checklist of all test data needs to be prepared before starting the test execution. The source of test data must be fully reliable.
21 CFR Part 11 applies to any electronic records or digitized signatures that are maintained, created, or processed under records requirements defined by the FDA. Any electronic records stored, signed, or processed digitally for life sciences, and biotechnology fall under FDA regulation.
Mandatory to all businesses operating in the US, life sciences, medical instrumentation, biotechnology, pharmaceuticals, or similar industries. Including non-food businesses under FDA jurisdiction meet 21 CFR Part 11 compliance. At present, since it is difficult to store paper records, almost all businesses bookkeeping digital and electronic records are mandated within the regulation.
Compliance Quest (CQ) enables 21 CFR Part 11 FDA for all life science organizations such as healthcare, pharmaceutical, biotechnology, medical manufacturing, medical devices, including other FDA-regulated industries. It facilitates implementing controls on auditing, system validation, digitized electronic signatures, and e-documentation for software systems involved in processing valuable data, business practices, and product development. 21 CFR Part 11 executes the FDA’s validation of all electronic records and electronic signatures as fully trustworthy, authentic, reliable, and legally equivalent to paper records and handwritten signatures. Helping adopt a future proof ‘paperless’ system of record keeping.
Audit Trails: Audit trails require the access controls to be revalidated with the proof of operator access creating a digital system of records. An important factor in understanding 21 CFR part 11 compliant software is mapping the way electronic records are created, modified, reviewed, authorized, and controlled.
System feature time to facilitate auditing for every single digital document and record- It should mandatorily indicate the record modifier user ID, the date and time of modification, and the specific items of modifications. Ensuring the trail is easily restored and demonstrated.
The system implementation of 21 CFR part 11 digital signatures. 21 CFR part 11 compliant electronic signatures attesting to the creation, review, or approval by an authorized reviewer.
Digital Signature: 21 CFR Part 11 compliance is fully focused on bookkeeping electronic records, streamlining activities, and e-signatures. For all captured digital signatures to be fully compliant, they are computed by rules and parameters verifying the ID of the signer and the authenticity of the data provided.
Access Vigilance: With access granted to authorized users, the legitimacy of the records and signatures for audit must be mandated. Each user with an unduplicated login credential enables all activities to be easily identified, illustrating all the authorized access controls in place.
The policy works: All policies regarding operating and maintaining the hardware, and software, including physical records of the organization are clearly documented. They are fully covered during training for anyone with the policy records access.
Validation: Regular system validation checks mandated are logged to meet all compliance requirements. All FDA auditors ensure the data integrity of the system prior to reviewing.
The checklist mandate for FDA 21 CFR part 11 assessment validation include:
- System compliance with FDA 21 CFR part 11 security requirements.
- Authorized user authentication credentials
- System data encryption
- Statement of procedure (SOP) of system management.
- Record maintenance as per the defined record retention period for each record type.
Training: 21 CFR Part 11 requires users with system access to be fully trained in protocol compliance. Employees are trained for specific roles with an awareness of the limitations of access controls and responsibilities. All training is documented so FDA auditors can review the operator audit trail by cross-referencing with the training logs.
A 21 CFR part 11 compliance checklist can assess a system’s compliance with the regulation.
Companies must deploy the 21 CFR Part 11 Compliance Checklist to the regulators ensuring a robust system to meet FDA criteria and standards. A comprehensive 21 CFR Part 11 compliance checklist guides all pharma businesses through the complexities of regulatory requirements assisting to meet the applicable compliance standards. The checklists also aid in the improvement of system processes and procedures establishments. Helping in identifying risk laden areas.
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