Document Control Software to Meet Regulatory Requirements

Posted April 5, 2021

A document control system is an important tool to make sure that all regulatory compliances are meant in industries that are highly regulated. The systems can benefit any organization ranging from startups to businesses that are already up and running. It’s vital to choose a document control software to meet regulatory requirements and to choose one that will give you all the features you require. Flexibility is key when choosing the best document management software for your company.

In 2018 there were 476 warning letters sent out by the FDA in the United States. Of these 476 letters, 201 of them were regarding manufacturing processes including document control. The regulatory bodies in North America investigate life science, medical device manufacturing and drug manufacturing companies.

If your company receives one of these warning letters, you’ll need to be ready to provide evidence of effective documentation practices to avoid any further action being taken. It’s easier to provide documents that are audit-ready when they have been stored electronically. Taking preventive actions for document storage is key for all types of highly regulated industries.

Effective document control software to meet regulatory requirements provides the following capabilities and benefits:

  • Alert stakeholders, owners and managers of possible issues
  • Streamline processes for corrective action
  • Eliminate the possibility of missing documentation

The failure to comply with regulations can be disastrous for any business. The best way to make sure that you are always on top of things is to use a document control system that is highly effective.

Document Control Software – Access Control

Document control software supports the automation of paperless processes and the management of these documents along with audit trails. When you are choosing the right document control systems an emphasis must be placed on access management so that only a select few can have access to the highly sensitive documents. There must be appropriate governance for access to prevent any leakage of information. The accidental exposure of data in industries that are highly regulated can lead to noncompliance issues. This will result in damage to the reputation of the brand, an advantage for the competition and other potential threats.

Access control should always be considered as a top priority. The document control software that you choose should offer custom controls and access based on the roles of individual employees. This will give you an advantage in terms of data security.

It’s estimated that only 66% of the industries that can be considered to be highly regulated are still using manual methods for the management purposes of documents. This can lead to a number of compliance problems and make it hard to produce an audit trail. If a warning letter has been delivered this can be a nightmare. All regulated businesses can benefit from document software that has been aligned to keep compliance reporting and documentation at an all-time high.

Document Control Solution – Necessary Compliance Factors

If you have a product that you are trying to bring to market or if you are dealing with an audit, some of the key factors that governing bodies will be looking for include the following:

  • Effective safeguards in place to guard against alteration, deletion or unauthorized revisions of documents
  • A complete recall of documents containing standard operating procedures that are outdated and other documents that are irrelevant
  • A total revision history, which will include the names of the people that did the editing and the revision dates

The best electronic control software for documents will help simplify the compliance of regulatory requirements that are complex. Some documents will require electronic signatures along with passwords. You must have a document control solution that will help reduce the risk of having audit trails that are spotty, incorrect forms or documentation that is incomplete.

Information Transparency

Any system for controlling documents has an important role to play in terms of access management to protect sensitive documents. At the same time, simplified access must be in place for authorized parties so that searches can be done quickly. Look for document management solutions that allow categorizations so that active and archived documents can be retrieved easily. This is the most efficient way to provide information transparency to privileged users.

Some of the key components of document software that will facilitate these factors include the following:

  • Easy and flexible searches using keywords
  • Restriction access based on role or identity
  • Ability to store multiple types of documents including spreadsheets and PDFs
  • Ease of finding both prior and edited versions of documents
  • Mobile access so that documents can be shared, edited and viewed on mobile devices
  • User access restrictions placed on who can delete and archive documents

Both the control and transparency of documents must be in place in the document control solution you choose.

Collaboration on a Global Level

When you find the right document control software to meet regulatory requirements, it must also have the capability to provide global collaboration. In today’s world, documents may need to be sent across the world to a different country. Businesses that operate on a global level must have effective document control systems in place to keep productivity high.

Global access also allows individuals that are on business trips access to the documents they need the most. When documentation is stored on the cloud, employees and business partners will be able to view, revise and restore the documents as required. This keeps the organization running at top performance. Other slow and manual processes such as faxing documents can greatly delay workflows, which would result in a competitive disadvantage for the company.

When you’re looking for the best document control software that meets all of the above requirements and much more, please visit our website now at You can take our state-of-the-art document software for highly-regulated industries for a test run and we are available to answer any questions you may have. Our document management system is also flexible and can be completely customized to meet the unique needs of your business.