Software Development Life Cycle (SDLC) is a process used by the software industry to design, develop and test high quality software.
The SDLC aims to produce a high-quality software that meets or exceeds customer expectations, reaches completion within times and cost estimates.
The software life cycle model that is selected should cover from its birth to its retirement.
Activities include:
Quality Planning
System Requirements Definition
Detailed Software Requirements Specification
Software Design Specification
Construction or Coding
Testing
Installation
Operation and Support
Maintenance
Retirement.
Verification, testing, & other tasks that support software validation occur during each of these activities.
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Evidence of design control, including how the requirements evolved during the development of the product, and requires risk management to be integrated into the design process
Software verification and validation conducted throughout the software development lifecycle
Documentation (evidence) to demonstrate compliance to regulations and to facilitate the investigation of software problems
Adequate planning to ensure effective execution of processes and high quality in the software product.
Risk management activities should be embedded throughout the software development activities
Deliverable During software development activities GxP System Impact Assessment
Compliance Plan
Product/Sprint Backlog
Requirements Risk Assessment
Design Documentation
Test Documentation
Trace Matrix
Compliance Report
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FDA’s Center for Devices and Radiological Health (CDRH) released its FY 2020 draft and final guidance list, which features a few repeats from last year and new drafts coming on device servicing and remanufacturing, unique device identification and patient-reported outcome measures used in device submissions, among others.
As in years past, CDRH divides the list between “A-list” draft and final guidance, which are a priority, and a smaller “B-list” of draft and final guidance, which CDRH says it will publish as resources permit.
USFDA Center for Devices and Radiological Health (CDRH) draft guidance on “Computer Software Assurance for Manufacturing, Operations, and Quality System Software”. It has emphasized on ‘Critical Thinking’ to be a crucial part while implementation of automated systems.
FDA is working to reduce the regulatory burden is through CSA. We’re still waiting on the agency to release the promised guidance, but they have hosted a webinar on the topic.
In brief it is a paradigm shift from document focused computer system validation practices to critical thinking assurance practices. The industry and the FDA are driving the shift toward computer software assurance (CSA).
The FDA doesn’t want companies creating documentation solely because of the FDA. The documentation should serve a purpose. And not all testing demands the same level of documentation. Deciding what needs the most attention is dependent on risk.
When looking at the impact that a feature will have, the FDA is most concerned with whether it’ll affect quality and/or patient safety.
However, risk is not just a matter of impact. Probability and detectability influence the overall risk. So, if an event would have a high impact, but isn’t probable and would easily be detected, the risk could still be considered low.
Traditionally, FDA’s CSV (Computer System Validation) focuses on documentation, followed by testing activities, assurance needs, and critical thinking. Whereas, in the new CSA model it focuses first on critical thinking and then on assurance needs, testing activities, and documentation.
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Computer system validation (CSV) is a much more familiar term than CSA, but CSA is the wave of the future in validating your software.
The FDA outlined a new approach to validation that would focus on confidence levels and help decrease the burden on regulated companies while maintaining high standards.
Traditional CSV uses waterfall development methodology, which most companies have replaced with agile development methodology. CSA is a similar shift from a highly regimented approach to a more adaptable one
With CSA, the FDA is placing the emphasis on what “Directly impacts patients or product quality.” Instead of starting with documentation, the new trend is to start with critical thinking.
Ask yourself how you use your system and why you’re doing everything in the validation process. This can be broken down into a four-step approach:
Identify your intended use.
Determine risk approach.
Perform risk and testing activities.
Create documentation.
Not every feature in a system needs to be validated at the same level.
A feature that lets you set up out-of-office notifications doesn’t require the rigorous testing — or the documentation — of a feature that controls the amount of active ingredient in a pharmaceutical.
CSA Approach:
Critical Thinking: Risk definition for each Software Features
Assurance: Demonstrate if the feature & functionality is working as desired
Testing Activities: Leverage and define the different test methods like Scripted and Unscripted testing
CSA Objectives:
Develop streamlined practice recommendations and pilots.
Modifications to the 820.70(i) and 820.50 regulatory languages.
Guidance development centered on this software category.
The FDA is ultimately concerned about patient safety; not how many documents a company can produce. That documentation should be the end of the validation process, not the beginning.
The new FDA guidance intends to focus on more testing and considerably less documentation.
CSA will reduce the Testing and Documentation efforts.
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‘If it’s not written down, then it didn’t happen!’
Documentation is important because the accurate capture of information plays an vital role in the pharmaceuticals and medical device industry.
Documents are a Mirror to show actual image of any pharmaceutical company.
Documents and products are produced in pharmaceuticals but regulatory bodies are interested to see documents first.
Good documentation is a systematic procedure of preparation, checking, verifying, issuing, storing and reviewing of any documents.
Document is any written statement or proof of any activity in pharmaceuticals. Documentations are to define the manufacturers system of information & control, to minimize the risk of misinterpretation & errors inherent in oral or casually written communication, to provide unambiguous procedures to be followed to provide confirmation of performance, to allow calculations to be checked & to allow tracing of batch history.
The basic rules in any good manufacturing practice (GMP) regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records.
Documentation helps to build up a detailed picture of what a activity has done in the past and what it is doing now and, thus, it provides a basis for planning what it is going to do in the future.
Regulatory inspectors, during their inspections often spend much time examining a company’s documents and records.Effective documentation enhances the visibility of the quality assurance system.
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Purpose of Documentations: • Defines specifications and procedures for all materials and methods of manufacture and control • Ensures all personnel know what to do and when to do it • Ensure that authorized persons have all information necessary for release of product • Ensures documented evidence, traceability, provide records and audit trail for investigation • Ensures availability of data for validation, review and statistical analysis.
Documentation and records used throughout the manufacturing process, as well as supporting processes, such as quality control and assurance, must meet the basic requirements of GDP, including the following:
Batch Record Forms
Bills of Materials (BOMs)
Specifications
Policies
Protocols
Standard Operating Procedures (SOPs)
Work Instructions (WIs)
Test Methods
Checklists
Forms/Log sheets
Training Assessments
Electronic and hardcopy Quality records (e.g. non-conformance, corrective and preventative actions, internal inspection, change control, training records etc.)
Certificate of Analyses (CoA) or Certificate of Compliance (CoC)
Technical transfer reports
Validation documentation
These key documents with the potential to impact product quality must be retained to provide a traceable, historical record of all activities.
Documentation must be readily retrievable in order to meet requirements associated with product investigations, periodic product review, or formal audits.
All pharmaceutical, bio science and healthcare companies, as well as their vendor partners, must observe GDP or face warnings or penalties levied by the FDA.
The implications of not following GDP are often severe and the organizations can get into serious troubles for not following the correct policies/guidelines.
Similar to the GMP the goal of following good documentation practices will absolutely help the industry to establish consistent practices that will minimize the risks of misinterpretations, errors in communication and ensuring great product quality.
Each pharmaceutical unit involved in manufacturing of medicinal products must make a firm commitment to quality and patient safety and implementation of proper GMP.
They must always operate under a robust quality management system and should not work only to pre-qualify their pharmaceutical products, rather companies should operate their manufacturing facilities under quality systems at all times.
Follow GMP/GDP to stay away from FORM 483’s & warning letters and always remember “If it is not DOCUMENTED, it’s not “DONE”!!
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Many pharma companies still use “hybrid systems” combining paper and electronic records: an electronic instrument is used to print results on paper.
Hybrid System – an environment consisting of both Electronic & paper-based Records (frequently characterized by handwritten signatures Executed on paper).
An example of hybrid system is the one in which the system user generates an electronic record using a computer based system & then is required to sign that record as per Regulatory Requirements.
However, the system does not have an electronic signature option, so the user has to print out the report and sign the paper copy. Now he has an electronic record and a paper/handwritten signature. The ‘system’ has an electronic and a paper component, hence the term, hybrid.
Hybrid systems combining electronic and paper-based records preserve the paper-based workflow. Realizing the full benefits of working electronically requires the implementation of electronic signatures
Hybrid systems require some specific and additional controls in reflection of their complexity and potential increased vulnerability to manipulation of data.
All component of hybrid system should be qualified and controlled in accordance with the predicate rule.
Always hybrid systems are clearly defined and identified, and that each contributing element of the system is validated.
Is an Electronic record can be signed using electronic signatures?
Yes. Since Part 11 does not require that electronic records be signed using electronic signatures, e-records may be signed with handwritten signatures that are applied to electronic records or handwritten signatures that are applied to a piece of paper.
If the handwritten signature is applied to a piece of paper, it must link to the electronic record.
The FDA will publish guidance on how to achieve this link in the future, but for now it is suggested that you include in the paper as much information as possible to accurately identify the unique electronic record (e.g., at least file name, size in bytes, creation date and a hash or checksum value.)
However, the master record is still the electronic record. Thus, signing a printout of an electronic record does not exempt the electronic record from Part 11 compliance.
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Open vs. Closed is one of the trickiest parts of the regulations, especially because the definitions provided by the FDA in Part 11 are different from those understood by the IT industry at large.
The open or closed portion turns on whether you as an organization have complete control over people accessing the system. If it’s something out on the internet, clearly the internet is the biggest open system in the world, so that’s not going to be considered a closed system.
What is Open System?
A computer system where user access is not controlled by the same people responsible for its contents.
Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.
The company cannot confirm the identity of all users prior to providing access to the electronic record system. In addition to electronic signatures, digital signatures are also required to verify the identity of the person signing the document.
Requirements for open systems:
21 CFR Part 11.30 places additional requirements on open systems. These include measures such as document encryption and the use of digital signature standards to ensure the authenticity, integrity and confidentiality of records.
Open systems typically mean that more people have access to the record-keeping system, so the security requirements should be slightly more comprehensive to help ensure that the records kept are accurate and reliable.
This section recommends that open systems are subject to the same 11 security requirements as closed systems, along with any additional appropriate measures such as document encryption and the use of digital signature standards to ensure the integrity and confidentiality of the records.
Digital signature requirements
The requirements of 21 CFR Part 11 regarding digital signatures will seem familiar to anyone who has dealt with this issue before and, for example, the German Signature Act:
Content: A digital signature must contain:
The name of the signatory
The date and time of the signature and
The meaning of the signature (e.g. review, approval, author).
Protection against falsification: It must not be possible to falsify the digital signature (21 CFR establishes the same de facto requirements as are in place for documents).
Link to document: The signature must be linked to the document in such a way that it cannot be used on other documents.
Uniqueness: Naturally, it must be possible to assign the signature to a specific individual.
Biometric and non-biometric methods: The identification must be based on biometric methods or two distinct identification components such as an identification code and password.
When using identification codes (e.g. user name, initials or number) and passwords, 21 CFR Part 11 establishes the following requirements in 11.200 (a) and 11.300:
Four-eyes principle: The electronic signature must be regulated in such a way that any attempted misuse of someone else’s electronic signature requires the collaboration of two or more individuals.
Unique combinations: The duplicate assignment of codes and passwords must not be possible.
Updating: Both codes and passwords must be regularly checked regularly to ensure that they are still sufficiently secure.
Loss management: In the event that codes, passwords, cards, etc. are lost, there must be a procedure that permits “disable/deactivate/deauthorization”.
Security measures: Suitable measures must be in place to protect against and detect unauthorized access attempts.
Testing: Input/output devices, including cards that bear or read authorization information, must be tested periodically to ensure that they are working correctly.
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A Computer system whose user access is controlled by the same people responsible for its contents.
*Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.
The company can confirm the identity of all users prior to providing access to the electronic record system and only electronic signatures are required.
Requirements for closed systems
Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine.
21 CFR Part 11.10 defines the requirements for closed systems. The idea behind the requirements is that the people who work with these systems must ensure the authenticity, integrity and, if necessary, confidentiality of the data.
For this reason, the following are obligatory:
System validation (Ensure consistent intended performance, accuracy, reliability, the ability to detect invalid or altered records).
Generation of accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency.
Ensuring the protection of recordsthroughout the records retention period.
Limiting system access to authorized individuals.
Use of computer-generated, time-stamped audit trails that show who changed what and when. But here the FDA is rowing back, as you can read in the above mentioned Guidance Document.
Operational system checks to ensure that (only) the permitted sequencing of steps and events is enforced – if necessary.
Authority checks to ensure that only authorized users can use the system (e.g. electronically generate and sign documents), and access the operating system, computer or peripherals.
Peripherals check to ensure that the inputs and outputs are correct.
Training of the persons who develop, maintain, or use electronic record/electronic signature systems
Prevention of falsification so that individuals are accountable and responsible in writing for what they sign.
Appropriate controls over System documentation e.g. on who has access to the system, how this access is granted, whether it be for the use or maintenance of the system, and on who changed what in the system and when (maintain an audit trail).
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Let’s be honest: No one really likes legacy systems.
Most legacy setups at companies happen because something else goes wrong – there’s a compliance issue, or a rollout is too difficult to do all at once, or ongoing projects require older software/hardware…or decision makers who just don’t like change
What is Legacy system?
Legacy system is an old method, technology, computer system, or application program relating to previous or outdated computer system. This can also imply that the system is out of date or in need of replacement.
In some organizations, a legacy system is defined by the obsolete operating system or hardware platform that it runs on. Whereas many systems these days run on either Linux, Unix, or Windows; some applications may run on a mainframe or the Tandem hardware platform, placing it into the legacy category.
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This means that the Agency does not intend to take enforcement action to enforce compliance with any part 11 requirements if all the following criteria are met for a specific system:
The system was operational before the effective date.
The system met all applicable predicate rule requirements before the effective date.
The system currently meets all applicable predicate rule requirements.
You have documented evidence and justification that the system is fit for its intended use(including having an acceptable level of record security and integrity, if applicable).
Challenges in legacy system:
Limited options are available in legacy system.
Maintenance was problematic due to the lack of part availability; they were having trouble locating refurbished parts.
No highly accurate result.
Not easily integrate with new technology.
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Use of Software as a Medical Device is continuing to increase. It can be used across a broad range of technology platforms, including medical device platforms, commercial “off-the-shelf” platforms, and virtual networks, to name a few.
Such software was previously referred to by industry, international regulators, and health care providers as “standalone software,” “medical device software,” and/or “health software,” and can sometimes be confused with other types of software.
Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use.
Application Software (IEEE):
Software designed to fill specific needs of a user; for example, software for navigation, payroll, or process control. Contrast with support software; system software.
What is COTS ?
The Food and Drug Administration (FDA) Glossary of Computerized Systems Software Development Terminology, published in 1995, defines COTS as “configurable, off-the-shelf software,” but within regulated industries the “c” also is understood to mean “commercial.” FDA now simply identifies software as off the-shelf (OTS) only (FDA, Jan. 11, 2002).
The use of off-the-shelf software in automated medical devices and in automated manufacturing and quality system operations is increasing. Off-the-shelf software may have many capabilities, only a few of which are needed by the device manufacturer.
When device manufacturers purchase “off-the-shelf” software, they must ensure that it will perform as intended in their chosen application.
Software Requirement & Specification:
Quality System regulation states that design input requirements must be documented, and that specified requirements must be verified. Regulation does not further clarify the distinction between the terms “requirement” and “specification.”
Requirements reflect the stated or implied needs of the customer, and may be market-based, contractual, or statutory, as well as an organization’s internal requirements. There can be many different kinds of requirements (e.g., design, functional, implementation, interface, performance, or physical requirements).
Software used as a component, part, or accessory of a medical device;
Software that is itself a medical device (e.g., blood establishment software);
Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment); and
Software used in implementation of the device manufacturer’s quality system (e.g., software that records and maintains the device history record).
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Good Automated Manufacturing Practice, Founded in 1991. International Society for Pharmaceutical Engineering (ISPE) sets the guidelines for manufacturers and the current Version is GAMP 5.
GAMP describes a set of principles and procedures that help ensure that pharmaceutical Software have required quality.
Computer system validation (CSV) following GAMP guidelines require users and suppliers to work together so that responsibilities regarding the validation process are understood.
For users: GAMP provides a documented assurance that a system is appropriate for the intended use before it goes “live.”
Why GAMP 5?
Facilitates the interpretation of regulatory requirements.
Establishes a common language and terminology.
Promotes a system life cycle approach based on good practice.
Clarifies roles and responsibilities.
Focus attention on those computerized systems with most impact on patient safety, product quality, and data integrity
Avoid duplication of activities
Purpose of Software Categorization:
In GAMP 3 and GAMP 4 the purpose of the GAMP categories had clear purpose, identifying which validation deliverables were not required. Categories 1-3 were considered to standard systems and the System Life Cycle Design (SLCD) documentation were not required, this included
Supplier Audits
Functional Specifications
Source Code Reviews
This implies a level of governance to be applied over suppliers independent of the maturity or complexity of the software.
While GAMP5 provides guidance to the approach based on the categories there are better rationales that can be put in place rather than the complexity of the software.
For example a Laboratory Instrument (Category 3 – COTS) which is pre-use and post-use calibrated or runs standards along with the test need less verification than a system where only the results are relied on. This can be documented within the validation plan or the risk assessments.
Categorization of Software:
The GAMP (Good Automated Manufacturing Practice) software categories were originally introduced to provide an initial assessment as to the validation requirements / deliverables.
GAMP 4, there were five categories of software:
Category 1: Operating systems
Category 2: Firmware
Category 3: Standard software
Category 4: Configured software
Category 5: Custom software
In GAMP5, these have been revised in GAMP5 to four categories.
Category 1 – Infrastructure software including operating systems, Database Managers, Network monitoring software, batch scheduling tools, configuration management tools etc.
Category 3 – Non configurable software including, commercial off the shelf software (COTS), Laboratory Instruments / Software. It includes Standard Software Packages.
Category 4 – Configured software including, LIMS, SCADA, DCS, CDS, etc. Configurable software packages provide standard interfaces and functions that enable configuration of user specific business processes.
Category 5 – Bespoke software. These systems or subsystems are developed to meet the specific needs of the regulated company.
Category 2 from GAMP 5 has been removed.
This related to firmware. At the time that GAMP4 was issued firmware was considered to be used for simple instruments. However as technology has advanced it has been recognized that complex software can be embedded (firmware) within systems.
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A static record format, such as a paper or electronic record, is one that is fixed and allows little or no interaction between the user and the record content.
Static record is used to indicate a fixed-data record such as a paper record or an electronic image.
Static data is data that does not change after being recorded. It is a fixed data set.
For example, once printed or converted to static electronic format chromatography records lose the capability of being reprocessed or enabling more detailed viewing of baselines
Dynamic Record:
Records in dynamic format, such as electronic records, allow an interactive relationship between the user and the record content.
For example, electronic records in database formats allow the user to track, trend and query data; chromatography records maintained as electronic records allow the user or reviewer (with appropriate access permissions) to reprocess the data and expand the baseline to view the integration more clearly.
Where it is not practical or feasibly possible to retain the original copy of source data, (e.g. MRI scans, where the source machine is not under the study sponsor’s control and the operator can only provide summary statistics) the risks and mitigation should be documented.
Dynamic means that the record format allows interaction between the user and the record content
Experts contrast static data with dynamic data, where dynamic data may change after it is recorded, and has to be continually updated.
Source: MHRA GXP Data Integrity Guidance and Definitions; Revision 1: March 2018
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“No matter who you are and what you do, your manners will have a direct impact on your professional and social success”.
David Conellias
At any age, regardless of your station in life or your salary, table manners are essential for two reasons.
One is to make others comfortable.
The second reason is to keep us from embarrassing ourselves
Good manners can give you the edge over another candidate, so, take some time to brush up your dining etiquette skills before you go to the interview.
Dining with a prospective employee allows employers to review your communication and interpersonal skills, as well as your table manners, in a more casual environment.
Meals are a common part of both the job search process and working with clients in the business world. Below is a list of tips to keep in mind when dining for business.
Eating with someone you don’t know well in a professional environment is a tricky situation. On the one hand, you’re trying to get to know the person better, but on the other hand, you’re also worried about what your eating habits say about you.
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Basic Dining-Table Etiquette Everyone Should Know And Follow
Be courteous to everyone, including restaurant staff.
If your meal arrives first, wait to eat until others have received their food as well
If possible, let the employer take the lead in ordering and order along the same price range as the host or choose an entrée in the middle of the price range.
Don’t talk with food in your mouth
It is best to order food that can be easily eaten with a knife and fork. Finger foods can be messy and are best left for informal dining.
Take small, manageable bites
It’s best to not drink alcoholic beverages during an interview. If your interviewer orders alcohol, use your best judgment and stay within your comfort zone(if of legal age). You can always opt for a seltzer or soft drink.
When dining at a formal table setting, a good rule of thumb is to begin with the outermost pieces of silverware and work towards the plate.
When in doubt about the table setting, always remember solids on the left (bread plates) and liquids (drinking glasses) on the right. Think “BMW”: Bread- Meal-Water. Wait to eat until everyone at the table has been served and your host has started his/her meal.
Eat at a moderate speed and don’t make others wait for you to finish. Remember — your first priority is the business, not the food.
When you are not eating, keep your hands on your lap or resting on the table with wrists on the edge of the table. Elbows on the table are acceptable only between courses, not while you are eating.
Used silverware should never touch the table; rather, it should rest on your plate.
If a piece of your silverware falls on the floor, pick it up if you can reach it and let the server know you need a clean one. If you cannot reach it, tell the server you dropped a piece of your silverware and ask for a clean one.
Don’t make a big fuss if you spill or break something on the table. Wipe it up with your napkin if it is small or call the waiter.
Place your napkin on your chair if you leave the table during a meal. Place your dirty napkin near your plate only when everyone has finished and you are ready to leave the table.
You should not leave the table during the meal except in an emergency. If you must go to the bathroom or if you suddenly become sick, simply excuse yourself. Later you can apologize to your host by saying that you did not feel well.
Say “no thank you” if you don’t like or want something.
It is inappropriate to ask for a doggy bag when you are a guest. Save the doggy bag for informal dining situations.
After the Meal
After you finish eating, partially fold your napkin and place it to the left of your plate. Wait until the host or hostess signals that the meal is over, you may stand.
After the meal is over, don’t eat and run. If nothing is planned after dinner, stick around for approximately an hour before saying good-bye to the host and thanking him or her for the dinner. If the event is informal, you may offer to help clean up.
Later
Always send the host or hostess a thank you note or card in the mail, and don’t wait more than a day or two after the event.
Address the host or hostess, thank him or her for the lovely dinner, and add another short, positive comment to show your appreciation. Your note may be brief but heartfelt.
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