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Every life sciences company that either sells or proposes to sell any kind of medical device has to follow the requirements under the Food and Drug Administration (FDA). This ensures that the company has a solid quality system and all the medical devices manufactured by them are safe and effective for their intended uses.
Which processes need to be compliant with FDA regulations?
Each and every manufacturing process that affects the quality of the end product needs to follow a certain set of regulations. Either it is the product design, raw material inspection, maintenance, or quality control checks each of these processes should have a quality system established.
Generally, the FDA requirements are enshrined in the Code of Federal Regulations, Title 21, Part 820 (21 CFR part 820). Since now more and more drug or medical device manufacturing companies are switching from a manual or paper-based processes to digital processes, a whole new set of regulations have been subjected under the FDA CFR 21 Part 11.
21 CFR Part 11 Compliance Checklist to Follow
1. Validation – For Security
- Is the entire system validated?
- Is there limited system access for authorized individuals?
- Is there a process defined in which only authorized individuals can use the system, electronically sign the documents, alter them or perform other operations?
- Is there any documented training available for the system that includes on-the-job training for system users, developers, IT support staff?
- Is there a written set of policies that make individuals fully accountable and responsible for each and every action initiated by them under their electronic signatures?
- Is data encrypted within the system?
- Are digital signatures used?
2. Audit Trails – For Traceability
- Does the system provide a secure, computer-generated, time-stamped audit trail (including date and time and actions such as create, modify, or delete electronic records)?
- After every change to an electronic record, is previously recorded information still available?
- Is the audit trail available for the purpose of reviewing and copying by the FDA?
- Does the audit trail include the User ID, set of events, a change log, and revision and change controls?
- Do the signed electronic records contain: the name of the signer, the date and time stamp, the purpose of the signing (such as approval, review, etc.)
3. Electronic Signatures – For Valid Use
- Are electronic signatures unique for every user?
- Is it possible to reuse or reassign the electronic signature to anyone else?
- Does each electronic signature link to its respective electronic record?
- Is the identity of an individual checked and thoroughly verified at the time of signing using an electronic signature?
4. Copies of Records – For Reference
- Is there a procedure defined to produce accurate and complete copies of electronic records on paper?
- Is the system capable of providing copies of records in the electronic form to serve the purpose of inspection, review, and copying by the FDA?
- Is the system well equipped to automate the conversion or export methods (PDF, XML, or SGML)?
5. Record Retention – For Efficiency
- Are controls in place to ensure that no individual can have the same combination of identification code and password?
- Is there a functionality to check that the validity of identification codes is periodically checked?
- Is there a need defined to reset passwords periodically?
- Is there a way to recall the identification codes and passwords under any circumstances (if a person leaves or is transferred)?
Is MSB Docs 21 CFR Part 11 Compliant?
Yes, MSB Docs is fully compliant with 21 CFR Part 11 regulations. We understand that FDA 21 CFR Part 11, is of enormous significance to life sciences companies that operate in the US. This regulation provides the criteria for acceptance by FDA that electronic signatures are considered equivalent to handwritten signatures which are executed on paper.
MSB Docs not only guarantees compliance but also provides the full identification of the signer and the sender along with its complete time-stamping details. To each of our clients, we offer detailed and defensible audit trails that ensure accountability at every step. The tamper-proof seal is embedded with each record that adds up a further layer of protection for your critical documents. We keep the privacy and security of our customers at the highest priority for which our system is compliant with industry-leading security standards. This made MSB Docs one of the most secure e-signing solutions available in the market. If that seems satisfying, get in touch with us to collaborate.
